Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT03575351
Status:
COMPLETED
Last Update Posted:
2025-08-03
First Post:
2018-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please Email:', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 60 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (Up to 16.5 months).', 'description': 'The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.\n\nRandomized SOC (92) for All-Cause Mortality is presented separately under "SOC pre-crossover only" and "SOC-JCAR017 Pre- and post-cross over" arms as pre-specified\n\nTreated SOC (91) for SAEs and Other AEs is presented separately under "SOC pre-crossover only" and "SOC-JCAR017 Pre- and post-cross over" arms as pre-specified', 'eventGroups': [{'id': 'EG000', 'title': 'SOC Arm (Pre-crossover Only)', 'description': "Participants received 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). 1 cycle = 3 weeks", 'otherNumAtRisk': 30, 'deathsNumAtRisk': 31, 'otherNumAffected': 30, 'seriousNumAtRisk': 30, 'deathsNumAffected': 9, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'Liso-cel Arm Only', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)', 'otherNumAtRisk': 92, 'deathsNumAtRisk': 92, 'otherNumAffected': 92, 'seriousNumAtRisk': 92, 'deathsNumAffected': 34, 'seriousNumAffected': 43}, {'id': 'EG002', 'title': 'SOC-JCAR017 Arm Pre- and Post-Crossover (All Crossed)', 'description': "participants received 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). Participants crossed over to JCAR017 regardless of if they received CAR T therapy or not.", 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 57, 'seriousNumAtRisk': 61, 'deathsNumAffected': 33, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 75}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 31}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 54}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cytokine release syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 24}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypogammaglobulinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vascular access site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 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cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': "Bowen's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Thyroid cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Event-free Survival (EFS) Per Independent Review Committee (IRC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '4.9'}, {'value': '29.5', 'comment': 'Upper limit not calculated due to insufficient number of events per Kaplan-Meier product-limit estimates.', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to death from any cause, PD, failure to achieve CR or PR by 9 weeks post randomization, or start of new antineoplastic therapy due to efficacy concerns, whichever occurs first (Up to 36 months)', 'description': 'Time from randomization to death, progressive disease (PD), failure to achieve complete response (CR) or partial response (PR) by 9 weeks or start of new antineoplastic therapy, whichever occurs first. CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \\> 50% in length. PD: LDi \\> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \\> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Progressive metabolic disease: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Complete Response Rate (CRR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'categories': [{'measurements': [{'value': '43.5', 'groupId': 'OG000', 'lowerLimit': '33.2', 'upperLimit': '54.2'}, {'value': '73.9', 'groupId': 'OG001', 'lowerLimit': '63.7', 'upperLimit': '82.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization up to 3 years post randomization (Up to 36 months)', 'description': 'Complete response rate (CRR) is defined as the percentage of participants achieving a best overall response of complete response (CR). Participants with unknown or missing response will be counted as non-evaluable in the analysis. CR: Target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, no extralymphatic sites, no new lesions. Complete metabolic response: Lymph nodes/extralymphatic sites score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Complete Response (CR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization up to 3 years post randomization (Up to 36 months)', 'description': 'The number of participants achieving a best overall response of complete response (CR). Participants with unknown or missing response will be counted as non-evaluable in the analysis. CR: Target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, no extralymphatic sites, no new lesions. Complete metabolic response: Lymph nodes/extralymphatic sites score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '8.6'}, {'value': 'NA', 'comment': 'Median and upper limit not calculated due to insufficient number of events per Kaplan-Meier product-limit estimates.', 'groupId': 'OG001', 'lowerLimit': '12.6', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to progression, or death from any cause, whichever occurs first (Up to 36 months)', 'description': 'Progression-free survival is defined as the time from randomization to progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi \\> 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \\> 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and upper limit not calculated due to insufficient number of events per Kaplan-Meier product-limit estimates.', 'groupId': 'OG000', 'lowerLimit': '18.2', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and upper limit not calculated due to insufficient number of events per Kaplan-Meier product-limit estimates.', 'groupId': 'OG001', 'lowerLimit': '42.8', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to time of death due to any cause (Up to 36 months)', 'description': 'Overall Survival (OS) is defined as the time from randomization to death due to any cause. Estimates of time to event are from Kaplan-Meier product-limit estimates.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'categories': [{'measurements': [{'value': '48.9', 'groupId': 'OG000', 'lowerLimit': '38.3', 'upperLimit': '59.6'}, {'value': '87.0', 'groupId': 'OG001', 'lowerLimit': '78.3', 'upperLimit': '93.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to PR or CR (Up to 36 months)', 'description': 'ORR is defined as the percentage of participants achieving a best overall response of partial response (PR) or complete response (CR). CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \\> 50% in length. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR) Per Independent Review Committee (IRC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'comment': 'Upper limit not calculated due to insufficient number of events per Kaplan-Meier product-limit estimates.', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and upper limit not calculated due to insufficient number of events per Kaplan-Meier product-limit estimates.', 'groupId': 'OG001', 'lowerLimit': '16.9', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to to disease progression, start of new antineoplastic therapy due to efficacy concerns or death, whichever occurs first (Up to 36 months)', 'description': 'DoR is defined as the time from first partial or complete response (CR or PR) to disease progression, start of new antineoplastic therapy due to efficacy concerns or death, whichever occurs first. CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \\> 50% in length. PD: LDi \\> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \\> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Progressive metabolic disease: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PR or CR'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Progression-free Survival on Next Line of Treatment (PFS-2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'title': 'Number of patients who died', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Number of patients with first progression', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Number of patients with second progression', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization to second objective progression, or death from any cause, whichever occurs first (Up to 36 months)', 'description': "Progression-free Survival (PFS)-2 based on investigator's assessment is defined as time from randomization to second objective progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi \\> 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \\> 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Event-free Survival (EFS) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'title': 'EFS Rate at 6 months', 'categories': [{'measurements': [{'value': '36.2', 'groupId': 'OG000', 'lowerLimit': '26.3', 'upperLimit': '46.1'}, {'value': '68.1', 'groupId': 'OG001', 'lowerLimit': '58.6', 'upperLimit': '77.7'}]}]}, {'title': 'EFS Rate at 12 months', 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '31.3'}, {'value': '57.0', 'groupId': 'OG001', 'lowerLimit': '46.8', 'upperLimit': '67.2'}]}]}, {'title': 'EFS Rate at 18 months', 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '31.3'}, {'value': '52.6', 'groupId': 'OG001', 'lowerLimit': '42.3', 'upperLimit': '62.8'}]}]}, {'title': 'EFS Rate at 24 months', 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000', 'lowerLimit': '13.0', 'upperLimit': '30.0'}, {'value': '51.4', 'groupId': 'OG001', 'lowerLimit': '41.1', 'upperLimit': '61.7'}]}]}, {'title': 'EFS Rate at 36 months', 'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': '27.3'}, {'value': '45.8', 'groupId': 'OG001', 'lowerLimit': '35.2', 'upperLimit': '56.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 6, 12, 18, 24, 36', 'description': 'EFS rate is defined as the percentage of participants free of any EFS event at fixed timepoints. Complete response: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. Partial response: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \\> 50% in length. Progression: LDi \\> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \\> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Metabolic progression: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'title': 'PFS Rate at 6 months', 'categories': [{'measurements': [{'value': '51.7', 'groupId': 'OG000', 'lowerLimit': '40.2', 'upperLimit': '63.1'}, {'value': '73.7', 'groupId': 'OG001', 'lowerLimit': '64.5', 'upperLimit': '83.0'}]}]}, {'title': 'PFS Rate at 12 months', 'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000', 'lowerLimit': '20.3', 'upperLimit': '42.4'}, {'value': '63.0', 'groupId': 'OG001', 'lowerLimit': '52.8', 'upperLimit': '73.2'}]}]}, {'title': 'PFS Rate at 18 months', 'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000', 'lowerLimit': '20.3', 'upperLimit': '42.4'}, {'value': '58.2', 'groupId': 'OG001', 'lowerLimit': '47.7', 'upperLimit': '68.7'}]}]}, {'title': 'PFS Rate at 24 months', 'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000', 'lowerLimit': '18.8', 'upperLimit': '40.7'}, {'value': '57.0', 'groupId': 'OG001', 'lowerLimit': '46.4', 'upperLimit': '67.5'}]}]}, {'title': 'PFS Rate at 36 months', 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000', 'lowerLimit': '15.9', 'upperLimit': '37.1'}, {'value': '50.9', 'groupId': 'OG001', 'lowerLimit': '39.9', 'upperLimit': '62.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 6, 12, 18, 24, 36', 'description': 'Progression-free Survival (PFS) rate is defined as the percentage of participants free of any PFS event at fixed timepoints. Progression-free survival is defined as the time from randomization to progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi \\> 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \\> 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'title': 'OS Rate at 6 months', 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000', 'lowerLimit': '82.4', 'upperLimit': '95.4'}, {'value': '93.4', 'groupId': 'OG001', 'lowerLimit': '88.4', 'upperLimit': '98.5'}]}]}, {'title': 'OS Rate at 12 months', 'categories': [{'measurements': [{'value': '72.0', 'groupId': 'OG000', 'lowerLimit': '62.7', 'upperLimit': '81.3'}, {'value': '83.5', 'groupId': 'OG001', 'lowerLimit': '75.8', 'upperLimit': '91.1'}]}]}, {'title': 'OS Rate at 18 months', 'categories': [{'measurements': [{'value': '61.7', 'groupId': 'OG000', 'lowerLimit': '51.5', 'upperLimit': '71.8'}, {'value': '73.3', 'groupId': 'OG001', 'lowerLimit': '64.2', 'upperLimit': '82.5'}]}]}, {'title': 'OS Rate at 24 months', 'categories': [{'measurements': [{'value': '58.2', 'groupId': 'OG000', 'lowerLimit': '47.9', 'upperLimit': '68.5'}, {'value': '67.5', 'groupId': 'OG001', 'lowerLimit': '57.8', 'upperLimit': '77.2'}]}]}, {'title': 'OS Rate at 36 months', 'categories': [{'measurements': [{'value': '51.8', 'groupId': 'OG000', 'lowerLimit': '41.2', 'upperLimit': '62.4'}, {'value': '62.8', 'groupId': 'OG001', 'lowerLimit': '52.7', 'upperLimit': '72.9'}]}]}, {'title': 'Participants who died', 'categories': [{'measurements': [{'value': '45.7', 'comment': 'Only percentage of participants who died to be reported', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '37.0', 'comment': 'Only percentage of participants who died to be reported', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Participants who were censored', 'categories': [{'measurements': [{'value': '54.3', 'comment': 'Only percentage of participants who were censored to be reported', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '63.0', 'comment': 'Only percentage of participants who were censored to be reported', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 6, 12, 18, 24, 36', 'description': 'Overall Survival (OS) rate is defined as the percentage of participants alive at fixed timepoints. OS is defined as the time from randomization to death due to any cause. Participants alive or lost to follow up at the time of analysis will be censored at the last date the participants was known to be alive.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'title': 'Overall participants with TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}, {'title': 'Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL) with TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'NIH: Follicular Lymphoma Grade 3B with TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'NIH: High-Grade B-cell Lymphoma with DLBCL Histology with TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma with TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma with TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo with TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'DLBCL: DLBCL from Transformed Indolent NHL with TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization to 90 days after last dose or start of new antineoplastic therapy, whichever occurs first (Up to 16.5 months)', 'description': 'An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relation with this treatment. TEAEs are adverse events occurring or worsening on or after the date of randomization and within 90 days after last dose of chemotherapy (Arm A), or within 90 days after the infusion of JCAR017 (Arm B) or start of new antineoplastic therapy, whichever occurs first as well as those AEs made known to the investigator at any time thereafter that are suspected of being related to study treatment. Graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants treated in any study medication per overall participants and in clinical, histological and molecular subgroups that are prespecified for this endpoint (subgroups are not mutually exclusive)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'title': 'Overall Participants with serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL) with serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'NIH: Follicular Lymphoma Grade 3B with serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NIH: High-Grade B-cell Lymphoma with DLBCL Histology with serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma with serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma with serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo with serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'DLBCL: DLBCL from Transformed Indolent NHL with serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization to 90 days after last dose or start of new antineoplastic therapy, whichever occurs first (Up to 16.5 months)', 'description': 'A serious adverse event is defined as any adverse event occurring at any dose that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or constitutes an important medical event. Treatment emergent adverse events are adverse events occurring or worsening on or after the date of randomization and within 90 days after last dose of chemotherapy (Arm A), or within 90 days after the infusion of JCAR017 (Arm B) or start of new antineoplastic therapy, whichever occurs first as well as those AEs made known to the investigator at any time thereafter that are suspected of being related to study treatment. Graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants treated in any study medication per overall participants and in clinical, histological and molecular subgroups that are prespecified for this endpoint (subgroups are not mutually exclusive)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematology Parameters 1: Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'title': 'Hemoglobin Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.98', 'spread': '13.408', 'groupId': 'OG000'}, {'value': '-14.94', 'spread': '14.628', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-25.00', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-30.83', 'spread': '19.013', 'groupId': 'OG000'}, {'value': '-15.78', 'spread': '19.410', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-22.00', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.80', 'spread': '14.935', 'groupId': 'OG000'}, {'value': '-3.16', 'spread': '19.755', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '19.242', 'groupId': 'OG000'}, {'value': '-0.52', 'spread': '15.632', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.17', 'spread': '14.598', 'groupId': 'OG000'}, {'value': '3.32', 'spread': '15.417', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.37', 'spread': '14.592', 'groupId': 'OG000'}, {'value': '7.38', 'spread': '12.854', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.88', 'spread': '18.996', 'groupId': 'OG000'}, {'value': '7.38', 'spread': '16.986', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.41', 'spread': '16.978', 'groupId': 'OG000'}, {'value': '13.63', 'spread': '12.417', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36', 'description': 'Change from baseline in hemoglobin. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with a baseline value and a post-baseline value at the time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Selected Hematology Parameters 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'title': 'Month 1 leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.815', 'spread': '6.9413', 'groupId': 'OG000'}, {'value': '-3.219', 'spread': '2.4688', 'groupId': 'OG001'}]}]}, {'title': 'Month 2 leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.870', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.445', 'spread': '5.8845', 'groupId': 'OG000'}, {'value': '-2.234', 'spread': '2.3520', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.180', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.699', 'spread': '1.9099', 'groupId': 'OG000'}, {'value': '-1.853', 'spread': '2.5876', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.710', 'spread': '3.0670', 'groupId': 'OG000'}, {'value': '-1.156', 'spread': '3.3604', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.427', 'spread': '1.4093', 'groupId': 'OG000'}, {'value': '-1.138', 'spread': '2.3772', 'groupId': 'OG001'}]}]}, {'title': 'Month 18 leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.598', 'spread': '1.6136', 'groupId': 'OG000'}, {'value': '-1.088', 'spread': '2.8028', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.694', 'spread': '3.0465', 'groupId': 'OG000'}, {'value': '-0.806', 'spread': '2.5709', 'groupId': 'OG001'}]}]}, {'title': 'Month 36 leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.761', 'spread': '2.3637', 'groupId': 'OG000'}, {'value': '-0.970', 'spread': '3.0158', 'groupId': 'OG001'}]}]}, {'title': 'Month 1 lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2824', 'spread': '0.43519', 'groupId': 'OG000'}, {'value': '-0.7380', 'spread': '0.43499', 'groupId': 'OG001'}]}]}, {'title': 'Month 2 lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2100', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4216', 'spread': '0.55872', 'groupId': 'OG000'}, {'value': '-0.1318', 'spread': '0.43385', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1700', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1343', 'spread': '0.38219', 'groupId': 'OG000'}, {'value': '-0.0845', 'spread': '0.48047', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3264', 'spread': '0.66121', 'groupId': 'OG000'}, {'value': '-0.0442', 'spread': '0.39684', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5089', 'spread': '0.71831', 'groupId': 'OG000'}, {'value': '0.0097', 'spread': '0.37252', 'groupId': 'OG001'}]}]}, {'title': 'Month 18 lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6942', 'spread': '0.98993', 'groupId': 'OG000'}, {'value': '0.2283', 'spread': '0.55421', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8688', 'spread': '1.12695', 'groupId': 'OG000'}, {'value': '0.3298', 'spread': '0.51386', 'groupId': 'OG001'}]}]}, {'title': 'Month 36 lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2253', 'spread': '1.20268', 'groupId': 'OG000'}, {'value': '0.3550', 'spread': '0.55387', 'groupId': 'OG001'}]}]}, {'title': 'Month 1 neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.368', 'spread': '6.5393', 'groupId': 'OG000'}, {'value': '-2.065', 'spread': '2.3479', 'groupId': 'OG001'}]}]}, {'title': 'Month 2 neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.590', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.621', 'spread': '6.8377', 'groupId': 'OG000'}, {'value': '-1.909', 'spread': '2.1727', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.160', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.648', 'spread': '1.7635', 'groupId': 'OG000'}, {'value': '-1.584', 'spread': '2.4539', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.879', 'spread': '2.9777', 'groupId': 'OG000'}, {'value': '-1.001', 'spread': '3.1318', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.822', 'spread': '1.5780', 'groupId': 'OG000'}, {'value': '-1.035', 'spread': '2.2898', 'groupId': 'OG001'}]}]}, {'title': 'Month 18 neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.167', 'spread': '1.3772', 'groupId': 'OG000'}, {'value': '-1.189', 'spread': '2.6342', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.124', 'spread': '2.5434', 'groupId': 'OG000'}, {'value': '-0.998', 'spread': '2.5506', 'groupId': 'OG001'}]}]}, {'title': 'Month 36 neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.404', 'spread': '1.8392', 'groupId': 'OG000'}, {'value': '-0.998', 'spread': '2.5222', 'groupId': 'OG001'}]}]}, {'title': 'Month 1 platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.9', 'spread': '140.94', 'groupId': 'OG000'}, {'value': '29.4', 'spread': '115.53', 'groupId': 'OG001'}]}]}, {'title': 'Month 2 platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.0', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-189.5', 'spread': '132.93', 'groupId': 'OG000'}, {'value': '-65.7', 'spread': '100.52', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-74.0', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-45.5', 'spread': '94.13', 'groupId': 'OG000'}, {'value': '-48.2', 'spread': '89.04', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-57.0', 'spread': '110.48', 'groupId': 'OG000'}, {'value': '-48.9', 'spread': '89.29', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-66.5', 'spread': '85.82', 'groupId': 'OG000'}, {'value': '-42.4', 'spread': '92.65', 'groupId': 'OG001'}]}]}, {'title': 'Month 18 platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-68.0', 'spread': '84.69', 'groupId': 'OG000'}, {'value': '-32.6', 'spread': '81.68', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-29.4', 'spread': '103.87', 'groupId': 'OG000'}, {'value': '-28.7', 'spread': '79.70', 'groupId': 'OG001'}]}]}, {'title': 'Month 36 platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-45.2', 'spread': '123.28', 'groupId': 'OG000'}, {'value': '-10.5', 'spread': '72.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36', 'description': 'Change from baseline in selected hematology parameters such as leukocytes, lymphocytes, neutrophils, and platelets. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with a baseline value and a post-baseline value at the time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Selected Chemistry Parameters 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'title': 'Month 1 Alanine Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.22', 'spread': '25.997', 'groupId': 'OG000'}, {'value': '-0.52', 'spread': '18.337', 'groupId': 'OG001'}]}]}, {'title': 'Month 2 Alanine Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.00', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 Alanine Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.40', 'spread': '22.295', 'groupId': 'OG000'}, {'value': '2.53', 'spread': '13.246', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 Alanine Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.00', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 Alanine Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.81', 'spread': '21.067', 'groupId': 'OG000'}, {'value': '3.08', 'spread': '14.813', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 Alanine Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.43', 'spread': '20.165', 'groupId': 'OG000'}, {'value': '5.23', 'spread': '16.660', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 Alanine Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.72', 'spread': '23.542', 'groupId': 'OG000'}, {'value': '4.19', 'spread': '19.653', 'groupId': 'OG001'}]}]}, {'title': 'Month 18 Alanine Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.40', 'spread': '15.892', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '10.943', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 Alanine Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.69', 'spread': '15.134', 'groupId': 'OG000'}, {'value': '1.88', 'spread': '13.211', 'groupId': 'OG001'}]}]}, {'title': 'Month 36 Alanine Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.41', 'spread': '17.429', 'groupId': 'OG000'}, {'value': '13.98', 'spread': '104.054', 'groupId': 'OG001'}]}]}, {'title': 'Month 1 Aspartate Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.38', 'spread': '16.624', 'groupId': 'OG000'}, {'value': '2.03', 'spread': '17.526', 'groupId': 'OG001'}]}]}, {'title': 'Month 2 Aspartate Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.00', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 Aspartate Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.47', 'spread': '17.248', 'groupId': 'OG000'}, {'value': '-1.24', 'spread': '8.800', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 Aspartate Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.00', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 Aspartate Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.23', 'spread': '15.911', 'groupId': 'OG000'}, {'value': '1.78', 'spread': '8.550', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 Aspartate Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.68', 'spread': '12.549', 'groupId': 'OG000'}, {'value': '2.12', 'spread': '10.355', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 Aspartate Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.44', 'spread': '16.180', 'groupId': 'OG000'}, {'value': '1.88', 'spread': '13.200', 'groupId': 'OG001'}]}]}, {'title': 'Month 18 Aspartate Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.90', 'spread': '7.663', 'groupId': 'OG000'}, {'value': '-1.22', 'spread': '7.452', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 Aspartate Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.63', 'spread': '9.172', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '10.757', 'groupId': 'OG001'}]}]}, {'title': 'Month 36 Aspartate Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.06', 'spread': '15.117', 'groupId': 'OG000'}, {'value': '14.95', 'spread': '94.651', 'groupId': 'OG001'}]}]}, {'title': 'Month 1 Lactate Dehydrogenase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-66.7', 'spread': '222.79', 'groupId': 'OG000'}, {'value': '-14.0', 'spread': '203.18', 'groupId': 'OG001'}]}]}, {'title': 'Month 2 Lactate Dehydrogenase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.0', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 Lactate Dehydrogenase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-57.2', 'spread': '377.22', 'groupId': 'OG000'}, {'value': '-84.1', 'spread': '183.29', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 Lactate Dehydrogenase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '117.0', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 Lactate Dehydrogenase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-85.5', 'spread': '310.71', 'groupId': 'OG000'}, {'value': '-53.7', 'spread': '183.53', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 Lactate Dehydrogenase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-85.0', 'spread': '362.52', 'groupId': 'OG000'}, {'value': '-62.0', 'spread': '186.25', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 Lactate Dehydrogenase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-52.9', 'spread': '74.56', 'groupId': 'OG000'}, {'value': '-41.9', 'spread': '207.30', 'groupId': 'OG001'}]}]}, {'title': 'Month 18 Lactate Dehydrogenase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-44.1', 'spread': '71.19', 'groupId': 'OG000'}, {'value': '-50.8', 'spread': '133.31', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 Lactate Dehydrogenase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-45.6', 'spread': '75.04', 'groupId': 'OG000'}, {'value': '-63.3', 'spread': '148.25', 'groupId': 'OG001'}]}]}, {'title': 'Month 36 Lactate Dehydrogenase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-46.0', 'spread': '85.14', 'groupId': 'OG000'}, {'value': '-59.9', 'spread': '124.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36', 'description': 'Change from baseline in selected chemistry parameters such as alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with a baseline value and a post-baseline value at the time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Selected Chemistry Parameters 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'title': 'Month 1 magnesium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.023', 'spread': '0.1145', 'groupId': 'OG000'}, {'value': '0.009', 'spread': '0.0933', 'groupId': 'OG001'}]}]}, {'title': 'Month 2 magnesium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.080', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 magnesium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.063', 'spread': '0.1210', 'groupId': 'OG000'}, {'value': '0.007', 'spread': '0.1010', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 magnesium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.200', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 magnesium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.041', 'spread': '0.1452', 'groupId': 'OG000'}, {'value': '0.015', 'spread': '0.1090', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 magnesium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.027', 'spread': '0.1459', 'groupId': 'OG000'}, {'value': '0.025', 'spread': '0.1079', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 magnesium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.012', 'spread': '0.1047', 'groupId': 'OG000'}, {'value': '0.031', 'spread': '0.1054', 'groupId': 'OG001'}]}]}, {'title': 'Month 18 magnesium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.033', 'spread': '0.0639', 'groupId': 'OG000'}, {'value': '0.032', 'spread': '0.1065', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 magnesium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.040', 'spread': '0.1145', 'groupId': 'OG000'}, {'value': '0.015', 'spread': '0.1027', 'groupId': 'OG001'}]}]}, {'title': 'Month 36 magnesium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.039', 'spread': '0.0920', 'groupId': 'OG000'}, {'value': '0.011', 'spread': '0.0751', 'groupId': 'OG001'}]}]}, {'title': 'Month 1 phosphate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.061', 'spread': '0.2643', 'groupId': 'OG000'}, {'value': '-0.038', 'spread': '0.2498', 'groupId': 'OG001'}]}]}, {'title': 'Month 2 phosphate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.030', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 phosphate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.128', 'spread': '0.3299', 'groupId': 'OG000'}, {'value': '0.039', 'spread': '0.2316', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 phosphate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.130', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 phosphate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.140', 'spread': '0.2166', 'groupId': 'OG000'}, {'value': '-0.020', 'spread': '0.2276', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 phosphate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.025', 'spread': '0.2020', 'groupId': 'OG000'}, {'value': '-0.028', 'spread': '0.2098', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 phosphate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.021', 'spread': '0.1578', 'groupId': 'OG000'}, {'value': '-0.090', 'spread': '0.2051', 'groupId': 'OG001'}]}]}, {'title': 'Month 18 phosphate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.025', 'spread': '0.2666', 'groupId': 'OG000'}, {'value': '-0.059', 'spread': '0.2224', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 phosphate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.064', 'spread': '0.2469', 'groupId': 'OG000'}, {'value': '-0.061', 'spread': '0.2549', 'groupId': 'OG001'}]}]}, {'title': 'Month 36 phosphate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.044', 'spread': '0.2464', 'groupId': 'OG000'}, {'value': '-0.061', 'spread': '0.2053', 'groupId': 'OG001'}]}]}, {'title': 'Month 1 potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.400', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.460', 'groupId': 'OG001'}]}]}, {'title': 'Month 2 potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.30', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.604', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.428', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.80', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.337', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.359', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.447', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.391', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.445', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.491', 'groupId': 'OG001'}]}]}, {'title': 'Month 18 potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.380', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.411', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.516', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.435', 'groupId': 'OG001'}]}]}, {'title': 'Month 36 potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.549', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.430', 'groupId': 'OG001'}]}]}, {'title': 'month 1 sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.75', 'spread': '3.493', 'groupId': 'OG000'}, {'value': '-1.09', 'spread': '2.875', 'groupId': 'OG001'}]}]}, {'title': 'month 2 sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.00', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'month 3 sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.86', 'spread': '4.496', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '3.054', 'groupId': 'OG001'}]}]}, {'title': 'month 4 sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.00', 'spread': 'NA', 'comment': 'insufficient number of participants to calculate standard deviation', 'groupId': 'OG000'}]}]}, {'title': 'month 6 sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.42', 'spread': '2.514', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '3.222', 'groupId': 'OG001'}]}]}, {'title': 'month 9 sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.52', 'spread': '2.108', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '3.111', 'groupId': 'OG001'}]}]}, {'title': 'month 12 sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.33', 'spread': '2.114', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '4.046', 'groupId': 'OG001'}]}]}, {'title': 'month 18 sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.45', 'spread': '2.964', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '3.572', 'groupId': 'OG001'}]}]}, {'title': 'month 24 sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.00', 'spread': '3.246', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '3.795', 'groupId': 'OG001'}]}]}, {'title': 'month 36 sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.44', 'spread': '2.229', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '3.432', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36', 'description': 'Change from baseline in selected chemistry parameters such as magnesium, phosphate, potassium, and sodium. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with a baseline value and a post-baseline value at the time point'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR) by Subgroups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'title': 'Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.7', 'groupId': 'OG000', 'lowerLimit': '38.2', 'upperLimit': '65.0'}, {'value': '86.7', 'groupId': 'OG001', 'lowerLimit': '75.4', 'upperLimit': '94.1'}]}]}, {'title': 'NIH: Follicular Lymphoma Grade 3B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '100.0'}]}]}, {'title': 'NIH: High-Grade B-cell Lymphoma with DLBCL Histology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000', 'lowerLimit': '21.8', 'upperLimit': '66.0'}, {'value': '81.8', 'groupId': 'OG001', 'lowerLimit': '59.7', 'upperLimit': '94.8'}]}]}, {'title': 'NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '70.1'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '63.1', 'upperLimit': '100.0'}]}]}, {'title': 'NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '100.0'}]}]}, {'title': 'Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.0', 'groupId': 'OG000', 'lowerLimit': '39.3', 'upperLimit': '68.2'}, {'value': '86.8', 'groupId': 'OG001', 'lowerLimit': '74.7', 'upperLimit': '94.5'}]}]}, {'title': 'DLBCL: DLBCL from Transformed Indolent NHL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '75.5'}, {'value': '85.7', 'groupId': 'OG001', 'lowerLimit': '42.1', 'upperLimit': '99.6'}]}]}, {'title': 'DLBCL: Germinal Center B-cell like (GCB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '33.8', 'upperLimit': '66.2'}, {'value': '91.1', 'groupId': 'OG001', 'lowerLimit': '78.8', 'upperLimit': '97.5'}]}]}, {'title': 'DLBCL: Activated B-cell-like, non-GCB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.8', 'groupId': 'OG000', 'lowerLimit': '26.4', 'upperLimit': '64.3'}, {'value': '85.7', 'groupId': 'OG001', 'lowerLimit': '63.7', 'upperLimit': '97.0'}]}]}, {'title': 'NHL: Double-hit lymphoma (DBL)/triple-hit lymphoma (THL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '19.1', 'upperLimit': '63.9'}, {'value': '81.8', 'groupId': 'OG001', 'lowerLimit': '59.7', 'upperLimit': '94.8'}]}]}, {'title': 'NHL: Non-DHL/THL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.4', 'groupId': 'OG000', 'lowerLimit': '39.3', 'upperLimit': '63.3'}, {'value': '88.6', 'groupId': 'OG001', 'lowerLimit': '78.7', 'upperLimit': '94.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to PR or CR (Up to 36 months)', 'description': 'ORR is defined as the percentage of participants achieving a best overall response of partial response (PR) or complete response (CR). CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \\> 50% in length. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants per clinical, histological and molecular subgroups that are pre-specified for ORR (subgroups are not mutually exclusive and participants are not exclusive to one subgroup)'}, {'type': 'SECONDARY', 'title': 'Event-free Survival (EFS) by Subgroups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'title': 'Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '6.4'}, {'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': 'NA'}]}]}, {'title': 'NIH: Follicular Lymphoma Grade 3B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median, the lower bound and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'NIH: High-Grade B-cell Lymphoma with DLBCL Histology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '3.9'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '12.6'}]}]}, {'title': 'NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'comment': 'The upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': 'NA'}]}]}, {'title': 'NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median, the lower bound and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '7.5'}, {'value': '33.2', 'comment': 'The upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': 'NA'}]}]}, {'title': 'DLBCL: DLBCL from Transformed Indolent NHL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '11.2'}, {'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': 'NA'}]}]}, {'title': 'DLBCL: Germinal Center B-cell like (GCB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '4.9'}, {'value': '11.7', 'comment': 'The upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': 'NA'}]}]}, {'title': 'DLBCL: Activated B-cell-like, non-GCB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '7.5'}, {'value': '33.2', 'comment': 'The upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': 'NA'}]}]}, {'title': 'NHL: Double-hit lymphoma (DBL)/triple-hit lymphoma (THL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '3.9'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '12.6'}]}]}, {'title': 'NHL: Non-DHL/THL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '6.4'}, {'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '15.6', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to death from any cause, PD, failure to achieve CR or PR by 9 weeks post randomization, or start of new antineoplastic therapy due to efficacy concerns, whichever occurs first (Up to 36 months)', 'description': 'Time from randomization to death, progressive disease (PD), failure to achieve complete response (CR) or partial response (PR) by 9 weeks or start of new antineoplastic therapy, whichever occurs first. CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \\> 50% in length. PD: LDi \\> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \\> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Progressive metabolic disease: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants per clinical, histological and molecular subgroups that are pre-specified for EFS (subgroups are not mutually exclusive)'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS) by Subgroups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'title': 'Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '8.6'}, {'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '30.9', 'upperLimit': 'NA'}]}]}, {'title': 'NIH: Follicular Lymphoma Grade 3B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median, the lower bound and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'NIH: High-Grade B-cell Lymphoma with DLBCL Histology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '6.5'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '14.8'}]}]}, {'title': 'NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': 'NA'}]}]}, {'title': 'NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '28.2', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median, the lower bound and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '8.6'}, {'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '12.2', 'upperLimit': 'NA'}]}]}, {'title': 'DLBCL: DLBCL from Transformed Indolent NHL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.4', 'comment': 'the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': 'NA'}]}]}, {'title': 'DLBCL: Germinal Center B-cell like (GCB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '6.4'}, {'value': '14.8', 'comment': 'the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': 'NA'}]}]}, {'title': 'DLBCL: Activated B-cell-like, non-GCB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '9.4'}, {'value': '33.2', 'comment': 'the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': 'NA'}]}]}, {'title': 'NHL: Double-hit lymphoma (DBL)/triple-hit lymphoma (THL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '6.5'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '14.8'}]}]}, {'title': 'NHL: Non-DHL/THL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '9.4'}, {'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '33.2', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to progression, or death from any cause, whichever occurs first (Up to 36 months)', 'description': 'Progression-free survival is defined as the time from randomization to progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi \\> 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \\> 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants per clinical, histological and molecular subgroups that are pre-specified for PFS (subgroups are not mutually exclusive)'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) by Subgroups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'title': 'Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '42.8', 'upperLimit': 'NA'}]}]}, {'title': 'NIH: Follicular Lymphoma Grade 3B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median, the lower bound and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'NIH: High-Grade B-cell Lymphoma with DLBCL Histology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.3', 'comment': 'The upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': 'NA'}, {'value': '13.3', 'comment': 'The upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '7.9', 'upperLimit': 'NA'}]}]}, {'title': 'NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '17.9', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': 'NA'}]}]}, {'title': 'NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '8.9', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median, the lower bound and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '16.7', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '42.8', 'upperLimit': 'NA'}]}]}, {'title': 'DLBCL: DLBCL from Transformed Indolent NHL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.2', 'comment': 'The upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '14.2', 'upperLimit': 'NA'}]}]}, {'title': 'DLBCL: Germinal Center B-cell like (GCB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '18.2', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '15.8', 'upperLimit': 'NA'}]}]}, {'title': 'DLBCL: Activated B-cell-like, non-GCB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.3', 'comment': 'The upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '9.7', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '32.4', 'upperLimit': 'NA'}]}]}, {'title': 'NHL: Double-hit lymphoma (DBL)/triple-hit lymphoma (THL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '30.7'}, {'value': '13.3', 'comment': 'The upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '7.9', 'upperLimit': 'NA'}]}]}, {'title': 'NHL: Non-DHL/THL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '27.5', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median, the lower bound and the upper bound of the 95% Confidence Interval could not be calculated due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to time of death due to any cause (Up to 36 months)', 'description': 'Overall Survival (OS) is defined as the time from randomization to death due to any cause. Estimates of time to event are from Kaplan-Meier product-limit estimates.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants per clinical, histological and molecular subgroups that are pre-specified for OS (subgroups are not mutually exclusive)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'title': 'Global Health/Quality of Life Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.55', 'spread': '25.655', 'groupId': 'OG000'}, {'value': '-5.23', 'spread': '18.004', 'groupId': 'OG001'}]}]}, {'title': 'Global Health/Quality of Life Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.78', 'spread': '24.734', 'groupId': 'OG000'}, {'value': '12.36', 'spread': '23.635', 'groupId': 'OG001'}]}]}, {'title': 'Global Health/Quality of Life Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.30', 'spread': '24.516', 'groupId': 'OG000'}, {'value': '12.50', 'spread': '22.252', 'groupId': 'OG001'}]}]}, {'title': 'Global Health/Quality of Life Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.63', 'spread': '32.865', 'groupId': 'OG000'}, {'value': '8.93', 'spread': '24.525', 'groupId': 'OG001'}]}]}, {'title': 'Global Health/Quality of Life Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.81', 'spread': '29.397', 'groupId': 'OG000'}, {'value': '8.33', 'spread': '23.442', 'groupId': 'OG001'}]}]}, {'title': 'Global Health/Quality of Life Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.50', 'spread': '28.934', 'groupId': 'OG000'}, {'value': '7.29', 'spread': '23.093', 'groupId': 'OG001'}]}]}, {'title': 'Global Health/Quality of Life Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.00', 'spread': '21.802', 'groupId': 'OG000'}, {'value': '2.67', 'spread': '21.071', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.94', 'spread': '19.867', 'groupId': 'OG000'}, {'value': '-4.03', 'spread': '16.339', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.08', 'spread': '11.081', 'groupId': 'OG000'}, {'value': '2.24', 'spread': '17.470', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.61', 'spread': '9.167', 'groupId': 'OG000'}, {'value': '5.00', 'spread': '21.825', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.00', 'spread': '17.817', 'groupId': 'OG000'}, {'value': '4.52', 'spread': '17.875', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.33', 'spread': '22.608', 'groupId': 'OG000'}, {'value': '1.73', 'spread': '17.027', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.67', 'spread': '18.645', 'groupId': 'OG000'}, {'value': '2.78', 'spread': '22.147', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.33', 'spread': '15.540', 'groupId': 'OG000'}, {'value': '-1.87', 'spread': '16.613', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive Functioning Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.54', 'spread': '19.047', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '16.462', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive Functioning Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.33', 'spread': '14.365', 'groupId': 'OG000'}, {'value': '3.45', 'spread': '20.596', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive Functioning Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.03', 'spread': '16.361', 'groupId': 'OG000'}, {'value': '9.72', 'spread': '23.008', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive Functioning Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.17', 'spread': '7.715', 'groupId': 'OG000'}, {'value': '4.17', 'spread': '27.074', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive Functioning Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '18.634', 'groupId': 'OG000'}, {'value': '4.17', 'spread': '26.580', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive Functioning Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '13.608', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '26.919', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive Functioning Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.67', 'spread': '9.461', 'groupId': 'OG000'}, {'value': '2.67', 'spread': '17.795', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.24', 'spread': '24.848', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '20.501', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.69', 'spread': '27.657', 'groupId': 'OG000'}, {'value': '-12.84', 'spread': '29.811', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.04', 'spread': '29.090', 'groupId': 'OG000'}, {'value': '-10.65', 'spread': '36.702', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.94', 'spread': '8.267', 'groupId': 'OG000'}, {'value': '-9.52', 'spread': '33.363', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.17', 'spread': '22.299', 'groupId': 'OG000'}, {'value': '-10.22', 'spread': '30.919', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.67', 'spread': '19.030', 'groupId': 'OG000'}, {'value': '-8.80', 'spread': '30.557', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.33', 'spread': '16.605', 'groupId': 'OG000'}, {'value': '-5.33', 'spread': '25.884', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, months 1, 6, 9, 12, 18, 24, 36', 'description': 'Change from baseline in EORTC QLQ-C30 specified parameters including global health/quality of life, cognitive functioning, physical functioning, and fatigue. It is composed of both multi-item scales and single item measures. All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL. Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning. Symptom scale/item higher score represents a high level of symptomatic problem. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with a health-related quality of life baseline assessment value and a post-baseline value at the time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.76', 'spread': '5.558', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '7.329', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.19', 'spread': '9.474', 'groupId': 'OG000'}, {'value': '3.52', 'spread': '10.805', 'groupId': 'OG001'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.11', 'spread': '9.597', 'groupId': 'OG000'}, {'value': '5.48', 'spread': '14.330', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.43', 'spread': '3.645', 'groupId': 'OG000'}, {'value': '3.93', 'spread': '13.485', 'groupId': 'OG001'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.50', 'spread': '5.632', 'groupId': 'OG000'}, {'value': '2.56', 'spread': '12.149', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.20', 'spread': '5.789', 'groupId': 'OG000'}, {'value': '2.18', 'spread': '12.374', 'groupId': 'OG001'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.90', 'spread': '5.152', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '9.478', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, months 1, 6, 9, 12, 18, 24, 36', 'description': 'Change from Baseline in the Functional Assessment of Cancer Therapy-Lymphoma 15-item lymphoma-specific "Additional concerns" subscale (FACT-Lym). The LYM items are scored on a 0 ("Not at all") to 4 ("Very much") response scale. Items are aggregated to a single score on a 0-60 scale. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected). A meaningful change from baseline in the FACT-Lym score, often referred to as the minimally important difference (MID), typically ranges between 6.5 and 11.2 points for the total score. This range indicates a clinically significant improvement or deterioration in a patient\'s health-related quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with a health-related quality of life baseline assessment value and a post-baseline value at the time point'}, {'type': 'SECONDARY', 'title': 'Hospital Resource Utilization (HRU) Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'title': 'Hospitalized', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalized due to Adverse Event (AE)', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalized due to Progression of Disease', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalized per protocol', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalized due to other reasons', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'Admitted to Intensive Care Unit (ICU)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 36 months', 'description': 'Hospital resource utilization (HRU) results including hospitalized, reasons for hospitalizations, and admitted to intensive care unit (ICU)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants treated in any study medication'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Completing High Dose Chemotherapy (HDCT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (rituximab, dexamethasone, cytarabine and cisplatin \\[R-DHAP\\], rituximab, ifosfamide, carboplatin and etoposide \\[R-ICE\\], rituximab, gemcitabine, dexamethasone, and cisplatin \\[R-GDP\\]) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'categories': [{'measurements': [{'value': '47.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 months after first dose', 'description': 'Percentage of Participants Completing High Dose Chemotherapy (HDCT).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in SOC arm'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Completing Hematopoietic Stem Cell Transplant (HSCT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'OG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'classes': [{'categories': [{'measurements': [{'value': '47.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 months after first dose', 'description': 'Percentage of Participants Completing Hematopoietic Stem Cell Transplant (HSCT).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in SOC arm'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (rituximab, dexamethasone, cytarabine and cisplatin \\[R-DHAP\\], rituximab, ifosfamide, carboplatin and etoposide \\[R-ICE\\], rituximab, gemcitabine, dexamethasone, and cisplatin \\[R-GDP\\]) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'FG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'comment': 'Received lymphodepleting chemotherapy (LDC)', 'groupId': 'FG001', 'numSubjects': '92'}]}, {'type': 'Treated', 'achievements': [{'comment': 'SOC Treatment', 'groupId': 'FG000', 'numSubjects': '91'}, {'comment': 'Liso-cel Treatment', 'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'Crossover', 'comment': 'Received SOC but were eligible to receive JCAR017 treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Received JCAR017 Conforming Cell Product', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'Received JCAR017 Nonconforming Cell Product', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death due to the COVID-19 pandemic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Disease relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Study drug manufacturing failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard of Care Arm', 'description': "3 cycles of standard of care (SOC) salvage therapy (rituximab, dexamethasone, cytarabine and cisplatin \\[R-DHAP\\], rituximab, ifosfamide, carboplatin and etoposide \\[R-ICE\\], rituximab, gemcitabine, dexamethasone, and cisplatin \\[R-GDP\\]) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks"}, {'id': 'BG001', 'title': 'Liso-cel Arm', 'description': '\\[Lymphodepleting chemotherapy (LDC)\\] Fludarabine IV (30 mg/m\\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.2', 'spread': '13.94', 'groupId': 'BG000'}, {'value': '58.3', 'spread': '12.61', 'groupId': 'BG001'}, {'value': '56.3', 'spread': '13.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}, {'title': 'Not Collected or Reported', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-09', 'size': 3499647, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-23T14:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 184}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2018-06-14', 'resultsFirstSubmitDate': '2024-10-23', 'studyFirstSubmitQcDate': '2018-06-28', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-15', 'studyFirstPostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-free Survival (EFS) Per Independent Review Committee (IRC)', 'timeFrame': 'From randomization to death from any cause, PD, failure to achieve CR or PR by 9 weeks post randomization, or start of new antineoplastic therapy due to efficacy concerns, whichever occurs first (Up to 36 months)', 'description': 'Time from randomization to death, progressive disease (PD), failure to achieve complete response (CR) or partial response (PR) by 9 weeks or start of new antineoplastic therapy, whichever occurs first. CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \\> 50% in length. PD: LDi \\> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \\> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Progressive metabolic disease: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid.'}], 'secondaryOutcomes': [{'measure': 'Complete Response Rate (CRR)', 'timeFrame': 'From randomization up to 3 years post randomization (Up to 36 months)', 'description': 'Complete response rate (CRR) is defined as the percentage of participants achieving a best overall response of complete response (CR). Participants with unknown or missing response will be counted as non-evaluable in the analysis. CR: Target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, no extralymphatic sites, no new lesions. Complete metabolic response: Lymph nodes/extralymphatic sites score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease.'}, {'measure': 'Number of Participants With Complete Response (CR)', 'timeFrame': 'From randomization up to 3 years post randomization (Up to 36 months)', 'description': 'The number of participants achieving a best overall response of complete response (CR). Participants with unknown or missing response will be counted as non-evaluable in the analysis. CR: Target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, no extralymphatic sites, no new lesions. Complete metabolic response: Lymph nodes/extralymphatic sites score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease.'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'From randomization to progression, or death from any cause, whichever occurs first (Up to 36 months)', 'description': 'Progression-free survival is defined as the time from randomization to progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi \\> 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \\> 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From randomization to time of death due to any cause (Up to 36 months)', 'description': 'Overall Survival (OS) is defined as the time from randomization to death due to any cause. Estimates of time to event are from Kaplan-Meier product-limit estimates.'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'From randomization to PR or CR (Up to 36 months)', 'description': 'ORR is defined as the percentage of participants achieving a best overall response of partial response (PR) or complete response (CR). CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \\> 50% in length. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline.'}, {'measure': 'Duration of Response (DoR) Per Independent Review Committee (IRC)', 'timeFrame': 'From randomization to to disease progression, start of new antineoplastic therapy due to efficacy concerns or death, whichever occurs first (Up to 36 months)', 'description': 'DoR is defined as the time from first partial or complete response (CR or PR) to disease progression, start of new antineoplastic therapy due to efficacy concerns or death, whichever occurs first. CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \\> 50% in length. PD: LDi \\> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \\> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Progressive metabolic disease: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid.'}, {'measure': 'Number of Participants With Progression-free Survival on Next Line of Treatment (PFS-2)', 'timeFrame': 'From randomization to second objective progression, or death from any cause, whichever occurs first (Up to 36 months)', 'description': "Progression-free Survival (PFS)-2 based on investigator's assessment is defined as time from randomization to second objective progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi \\> 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \\> 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid."}, {'measure': 'Event-free Survival (EFS) Rate', 'timeFrame': 'Months 6, 12, 18, 24, 36', 'description': 'EFS rate is defined as the percentage of participants free of any EFS event at fixed timepoints. Complete response: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. Partial response: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \\> 50% in length. Progression: LDi \\> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \\> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Metabolic progression: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid.'}, {'measure': 'Progression-free Survival (PFS) Rate', 'timeFrame': 'Months 6, 12, 18, 24, 36', 'description': 'Progression-free Survival (PFS) rate is defined as the percentage of participants free of any PFS event at fixed timepoints. Progression-free survival is defined as the time from randomization to progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi \\> 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \\> 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid.'}, {'measure': 'Overall Survival (OS) Rate', 'timeFrame': 'Months 6, 12, 18, 24, 36', 'description': 'Overall Survival (OS) rate is defined as the percentage of participants alive at fixed timepoints. OS is defined as the time from randomization to death due to any cause. Participants alive or lost to follow up at the time of analysis will be censored at the last date the participants was known to be alive.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'From randomization to 90 days after last dose or start of new antineoplastic therapy, whichever occurs first (Up to 16.5 months)', 'description': 'An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relation with this treatment. TEAEs are adverse events occurring or worsening on or after the date of randomization and within 90 days after last dose of chemotherapy (Arm A), or within 90 days after the infusion of JCAR017 (Arm B) or start of new antineoplastic therapy, whichever occurs first as well as those AEs made known to the investigator at any time thereafter that are suspected of being related to study treatment. Graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.'}, {'measure': 'Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'From randomization to 90 days after last dose or start of new antineoplastic therapy, whichever occurs first (Up to 16.5 months)', 'description': 'A serious adverse event is defined as any adverse event occurring at any dose that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or constitutes an important medical event. Treatment emergent adverse events are adverse events occurring or worsening on or after the date of randomization and within 90 days after last dose of chemotherapy (Arm A), or within 90 days after the infusion of JCAR017 (Arm B) or start of new antineoplastic therapy, whichever occurs first as well as those AEs made known to the investigator at any time thereafter that are suspected of being related to study treatment. Graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.'}, {'measure': 'Change From Baseline in Hematology Parameters 1: Hemoglobin', 'timeFrame': 'baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36', 'description': 'Change from baseline in hemoglobin. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).'}, {'measure': 'Change From Baseline in Selected Hematology Parameters 2', 'timeFrame': 'baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36', 'description': 'Change from baseline in selected hematology parameters such as leukocytes, lymphocytes, neutrophils, and platelets. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).'}, {'measure': 'Change From Baseline in Selected Chemistry Parameters 1', 'timeFrame': 'baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36', 'description': 'Change from baseline in selected chemistry parameters such as alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).'}, {'measure': 'Change From Baseline in Selected Chemistry Parameters 2', 'timeFrame': 'baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36', 'description': 'Change from baseline in selected chemistry parameters such as magnesium, phosphate, potassium, and sodium. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).'}, {'measure': 'Overall Response Rate (ORR) by Subgroups', 'timeFrame': 'From randomization to PR or CR (Up to 36 months)', 'description': 'ORR is defined as the percentage of participants achieving a best overall response of partial response (PR) or complete response (CR). CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \\> 50% in length. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline.'}, {'measure': 'Event-free Survival (EFS) by Subgroups', 'timeFrame': 'From randomization to death from any cause, PD, failure to achieve CR or PR by 9 weeks post randomization, or start of new antineoplastic therapy due to efficacy concerns, whichever occurs first (Up to 36 months)', 'description': 'Time from randomization to death, progressive disease (PD), failure to achieve complete response (CR) or partial response (PR) by 9 weeks or start of new antineoplastic therapy, whichever occurs first. CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \\> 50% in length. PD: LDi \\> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \\> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Progressive metabolic disease: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid.'}, {'measure': 'Progression-free Survival (PFS) by Subgroups', 'timeFrame': 'From randomization to progression, or death from any cause, whichever occurs first (Up to 36 months)', 'description': 'Progression-free survival is defined as the time from randomization to progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi \\> 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \\> 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid.'}, {'measure': 'Overall Survival (OS) by Subgroups', 'timeFrame': 'From randomization to time of death due to any cause (Up to 36 months)', 'description': 'Overall Survival (OS) is defined as the time from randomization to death due to any cause. Estimates of time to event are from Kaplan-Meier product-limit estimates.'}, {'measure': 'Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)', 'timeFrame': 'baseline, months 1, 6, 9, 12, 18, 24, 36', 'description': 'Change from baseline in EORTC QLQ-C30 specified parameters including global health/quality of life, cognitive functioning, physical functioning, and fatigue. It is composed of both multi-item scales and single item measures. All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL. Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning. Symptom scale/item higher score represents a high level of symptomatic problem. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).'}, {'measure': 'Change From Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym)', 'timeFrame': 'baseline, months 1, 6, 9, 12, 18, 24, 36', 'description': 'Change from Baseline in the Functional Assessment of Cancer Therapy-Lymphoma 15-item lymphoma-specific "Additional concerns" subscale (FACT-Lym). The LYM items are scored on a 0 ("Not at all") to 4 ("Very much") response scale. Items are aggregated to a single score on a 0-60 scale. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected). A meaningful change from baseline in the FACT-Lym score, often referred to as the minimally important difference (MID), typically ranges between 6.5 and 11.2 points for the total score. This range indicates a clinically significant improvement or deterioration in a patient\'s health-related quality of life.'}, {'measure': 'Hospital Resource Utilization (HRU) Results', 'timeFrame': 'Up to 36 months', 'description': 'Hospital resource utilization (HRU) results including hospitalized, reasons for hospitalizations, and admitted to intensive care unit (ICU)'}, {'measure': 'Percentage of Participants Completing High Dose Chemotherapy (HDCT)', 'timeFrame': 'Up to 5 months after first dose', 'description': 'Percentage of Participants Completing High Dose Chemotherapy (HDCT).'}, {'measure': 'Percentage of Participants Completing Hematopoietic Stem Cell Transplant (HSCT)', 'timeFrame': 'Up to 5 months after first dose', 'description': 'Percentage of Participants Completing Hematopoietic Stem Cell Transplant (HSCT).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-Hodgkin Lymphomas', 'DLBCL', 'Efficacy', 'Safety', 'JCAR017', 'Liso-cel', 'High-Risk', 'Relapsed', 'Refractory', 'B-cell NHL'], 'conditions': ['Lymphoma, Non-Hodgkin']}, 'referencesModule': {'references': [{'pmid': '40623279', 'type': 'DERIVED', 'citation': 'Kamdar M, Solomon SR, Arnason J, Johnston PB, Glass B, Bachanova V, Ibrahimi S, Mielke S, Mutsaers P, Hernandez-Ilizaliturri F, Izutsu K, Morschhauser F, Lunning M, Chow VA, Montheard S, Santamaria J, Colicino S, Ogasawara K, Stepan L, Liu FF, Abramson JS. Lisocabtagene Maraleucel Versus Standard of Care for Second-Line Relapsed/Refractory Large B-Cell Lymphoma: 3-Year Follow-Up From the Randomized, Phase III TRANSFORM Study. J Clin Oncol. 2025 Aug 20;43(24):2671-2678. doi: 10.1200/JCO-25-00399. Epub 2025 Jul 7.'}, {'pmid': '38547003', 'type': 'DERIVED', 'citation': 'Abramson JS, Solomon SR, Arnason J, Johnston PB, Glass B, Bachanova V, Ibrahimi S, Mielke S, Mutsaers P, Hernandez-Ilizaliturri F, Izutsu K, Morschhauser F, Lunning M, Crotta A, Montheard S, Previtali A, Ogasawara K, Kamdar M. Plain language summary of the TRANSFORM study primary analysis results: liso-cell as a second treatment regimen for large B-cell lymphoma following failure of the first treatment regimen. Future Oncol. 2024;20(21):1455-1465. doi: 10.2217/fon-2023-0898. Epub 2024 Mar 28.'}, {'pmid': '37544410', 'type': 'DERIVED', 'citation': 'Saeedian M, Badaracco J, Botros A, Gitlin M, Keating SJ. Estimating the Cost per Clinical Outcome of Second-Line Liso-Cel Versus Autologous Stem Cell Transplantation in Patients with Transplantation-Intended Relapsed/Refractory Large B Cell Lymphoma. Transplant Cell Ther. 2023 Nov;29(11):712.e1-712.e7. doi: 10.1016/j.jtct.2023.08.001. Epub 2023 Aug 5.'}, {'pmid': '36542826', 'type': 'DERIVED', 'citation': 'Abramson JS, Solomon SR, Arnason J, Johnston PB, Glass B, Bachanova V, Ibrahimi S, Mielke S, Mutsaers P, Hernandez-Ilizaliturri F, Izutsu K, Morschhauser F, Lunning M, Crotta A, Montheard S, Previtali A, Ogasawara K, Kamdar M. Lisocabtagene maraleucel as second-line therapy for large B-cell lymphoma: primary analysis of the phase 3 TRANSFORM study. Blood. 2023 Apr 6;141(14):1675-1684. doi: 10.1182/blood.2022018730.'}, {'pmid': '35717989', 'type': 'DERIVED', 'citation': 'Kamdar M, Solomon SR, Arnason J, Johnston PB, Glass B, Bachanova V, Ibrahimi S, Mielke S, Mutsaers P, Hernandez-Ilizaliturri F, Izutsu K, Morschhauser F, Lunning M, Maloney DG, Crotta A, Montheard S, Previtali A, Stepan L, Ogasawara K, Mack T, Abramson JS; TRANSFORM Investigators. Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma (TRANSFORM): results from an interim analysis of an open-label, randomised, phase 3 trial. Lancet. 2022 Jun 18;399(10343):2294-2308. doi: 10.1016/S0140-6736(22)00662-6.'}, {'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.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'http://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': "The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.\n\nThis is a randomized, open-label, parallel-group, multi-center trial in adult subjects with Relapsed or refractory (R/R) aggressive Non-Hodgkin lymphoma (NHL) to compare safety and efficacy between the standard of care (SOC) strategy versus JCAR017 (also known as lisocabtagene maraleucel or liso-cel). Subjects will be randomized to either receive SOC (Arm A) or to receive JCAR017 (Arm B).\n\nAll subjects randomized to Arm A will receive Standard of care (SOC) salvage therapy (R-DHAP, RICE or R-GDP) as per physician's choice before proceeding to High dose chemotherapy (HDCT) and Hematopoietic stem cell transplant (HSCT).\n\nSubjects from Arm A may be allowed to cross over and receive JCAR017 upon confirmation of an EFS event.\n\nSubjects randomized to Arm B will receive Lymphodepleting (LD) chemotherapy followed by JCAR017 infusion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is ≥ 18 years and ≤ 75 years of age at the time of signing the informed consent form (ICF).\n2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.\n3. Histologically proven diffuse large B-cell lymphoma (DLBCL) NOS (de novo or transformed indolent NHL), high grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple-hit lymphoma \\[DHL/THL\\]), primary mediastinal (thymic) large B-cell lymphoma (PMBCL), T cell/histiocyte-rich large B-cell lymphoma (THRBCL) or follicular lymphoma grade 3B. Enough tumor material must be available for confirmation by central pathology.\n4. Refractory or relapsed within 12 months from CD20 antibody and anthracycline containing first line therapy.\n5. \\[18F\\] fluorodeoxyglucose (FDG) positron emission tomography (PET) positive lesion at screening. (Deauville score 4 or 5)\n6. Adequate organ function\n7. Participants must agree to use effective contraception\n\nExclusion Criteria:\n\n1. Subjects not eligible for hematopoietic stem cell transplantation (HSCT).\n2. Subjects planned to undergo allogeneic stem cell transplantation.\n3. Subjects with, primary cutaneous large B-cell lymphoma, EBV (Epstein-Barr virus) positive DLBCL, Burkitt lymphoma or transformation from chronic lymphocytic leukemia/small lymphocytic lymphoma (Richter transformation).\n4. Subjects with prior history of malignancies, other than aggressive R/R NHL, unless the subject has been free of the disease for ≥ 2 years with the exception of the following noninvasive malignancies:\n\n * Basal cell carcinoma of the skin\n * Squamous cell carcinoma of the skin\n * Carcinoma in situ of the cervix\n * Carcinoma in situ of the breast\n * Incidental histologic finding of prostate cancer (T1a or T1b using the TNM \\[tumor, nodes, metastasis\\] clinical staging system) or prostate cancer that is curative.\n * Other completely resected stage 1 solid tumor with low risk for recurrence\n5. Treatment with any prior gene therapy product.\n6. Subjects who have received previous CD19-targeted therapy.\n7. Subjects with active hepatitis B, or active hepatitis C are excluded. Subjects with negative polymerase chain reaction (PCR) assay for viral load for hepatitis B or C are permitted. Subjects positive for hepatitis B surface antigen and/or anti-hepatitis B core antibody with negative viral load are eligible and should be considered for prophylactic antiviral therapy. Subjects with a history of or active human immunodeficiency virus (HIV) are excluded.\n8. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection (including tuberculosis) despite appropriate antibiotics or other treatment.\n9. Active autoimmune disease requiring immunosuppressive therapy.\n10. History of any one of the following cardiovascular conditions within the past 6 months prior to signing the ICF: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease.\n11. History or presence of clinically relevant central nervous system (CNS) pathology\n12. Pregnant or nursing (lactating) women.'}, 'identificationModule': {'nctId': 'NCT03575351', 'acronym': 'TRANSFORM', 'briefTitle': 'A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'A Global Randomized Multicenter Phase 3 Trial of JCAR017 Compared to Standard of Care in Adult Subjects With High-risk, Second-line, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas (TRANSFORM).', 'orgStudyIdInfo': {'id': 'JCAR017-BCM-003'}, 'secondaryIdInfos': [{'id': 'U1111-1213-1944', 'type': 'REGISTRY', 'domain': 'WHO'}, {'id': '2018-000929-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A - Standard of Care (SOC)', 'description': 'Subjects should receive SOC (R-DHAP, R-ICE or R-GDP) followed by HDCT (BEAM) and HSCT. Standard of care regimen will be administered as per investigator decision.', 'interventionNames': ['Drug: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B - JCAR017', 'description': 'Lymphodepleting chemotherapy with intravenous (IV) fludarabine (30 mg/m2/day for 3 days) plus cyclophosphamide IV (300 mg/m2/day for 3 days) (flu/cy) concurrently followed by JCAR017 infusion.', 'interventionNames': ['Genetic: JCAR017']}], 'interventions': [{'name': 'Standard of Care', 'type': 'DRUG', 'description': 'Standard of Care', 'armGroupLabels': ['Arm A - Standard of Care (SOC)']}, {'name': 'JCAR017', 'type': 'GENETIC', 'otherNames': ['lisocabtagene maraleucel or liso-cel'], 'description': 'JCAR017', 'armGroupLabels': ['Arm B - JCAR017']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution - 129', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution - 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