Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT03484702
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2018-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'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': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, '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, Serious Adverse Events and Other (Not Including Serious) Adverse Events from their date of leukapheresis until their study completion (assessed up to approximately 63 months).', 'description': 'All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that underwent leukapheresis and may or may not have received at least 1 dose of JCAR017.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 40, 'seriousNumAtRisk': 45, 'deathsNumAffected': 32, 'seriousNumAffected': 19}, {'id': 'EG001', 'title': 'Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 25, 'seriousNumAtRisk': 32, 'deathsNumAffected': 22, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 12, 'seriousNumAtRisk': 14, 'deathsNumAffected': 9, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort 5: Primary Central Nervous System Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 5, 'seriousNumAtRisk': 7, 'deathsNumAffected': 5, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 9, 'seriousNumAtRisk': 11, 'deathsNumAffected': 4, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Acquired antithrombin III deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypofibrinogenaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Keratopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Catheter site related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cytokine release syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypogammaglobulinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Varicella zoster virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Allergic transfusion reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Injury, poisoning 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CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG001', 'title': 'Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG002', 'title': 'Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'classes': [{'categories': [{'measurements': [{'value': '61.1', 'groupId': 'OG000', 'lowerLimit': '43.5', 'upperLimit': '76.9'}, {'value': '63.0', 'groupId': 'OG001', 'lowerLimit': '42.4', 'upperLimit': '80.6'}, {'value': '70.0', 'groupId': 'OG002', 'lowerLimit': '34.8', 'upperLimit': '93.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)', 'description': 'Overall response rate (ORR) by Independent Review Committee (Cohorts 1, 2, 3). ORR is the percent of participants with best overall response of complete response (CR) or partial response (PR).\n\nComplete response via PET-CT:\n\n* Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease\n\nComplete response via CT scan:\n\n* Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter.\n* Nonmeasured lesion: No\n* New lesions: No\n* Bone marrow: Normal\n\nPartial response via PET-CT:\n\n* Lymph nodes/extralymphatic: Score 4, 5b, reduced uptake from baseline\n* New lesions: No\n* Bone marrow: Residual uptake higher than normal, reduced from baseline\n\nPartial response via CT scan:\n\n* Lymph nodes/extralymphatic: 50% decrease in sum of diameters of \\<= 6 target measurable nodes/extranodal sites\n* Nonmeasured lesion: No\n* Organ enlargement: Spleen length decreased \\> 50%\n* New lesions: No', 'unitOfMeasure': 'Percent of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the JCAR017 treated set. Prespecified to be reported for cohorts 1,2, and 3 only.'}, {'type': 'PRIMARY', 'title': 'Overall Response Rate (ORR) Per Investigator in Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)', 'description': 'Overall response rate (ORR) is the percent of participants with best overall response of complete response (CR) or partial response (PR).\n\nComplete response via PET-CT:\n\n* Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease\n\nComplete response via CT scan:\n\n* Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter.\n* Nonmeasured lesion: None\n* New lesions: No\n* Bone marrow: Normal\n\nPartial response via PET-CT:\n\n* Lymph nodes/extralymphatic: Score 4, 5b, reduced uptake from baseline\n* New lesions: None\n* Bone marrow: Residual uptake higher than normal, reduced from baseline\n\nPartial response via CT scan:\n\n* Lymph nodes/extralymphatic: 50% decrease in sum of diameters of \\<= 6 target measurable nodes/extranodal sites\n* Nonmeasured lesion: None/normal\n* Organ enlargement: Spleen length decreased \\> 50%\n* New lesions: No', 'unitOfMeasure': 'Percent of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the JCAR017 treated set. Prespecified to be reported for cohort 4 only.'}, {'type': 'PRIMARY', 'title': 'Overall Response Rate (ORR) Per Investigator in Cohort 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 5: Primary Central Nervous System Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'classes': [{'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000', 'lowerLimit': '28.4', 'upperLimit': '99.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)', 'description': 'Overall response rate (ORR) determined by Investigator assessment after JCAR017 infusion. The ORR is the percent of participants with best overall response (BOR) of either complete response (CR), complete response unconfirmed (Cru) or partial response (PR).\n\nComplete response (CR):\n\n* Brain imaging: No contrast enhancement\n* Corticosteroid dose: None\n* Eye examination: Normal\n* Cerebrospinal fluid cytology: Negative\n\nComplete response unconfirmed (CRu):\n\n* Brain imaging: No contrast enhancement, Minimal abnormality\n* Corticosteroid dose: Any\n* Eye examination: Normal, minor RPE abnormality\n* Cerebrospinal fluid cytology: Negative\n\nPartial response (PR):\n\n* Brain imaging: 50% decrease in enhancing tumor, no contrast enhancement.\n* Corticosteroid dose: Irrelevant\n* Eye examination: Minor RPE abnormality, decrease in vitreous cells or retinal infiltrate.\n* Cerebrospinal fluid cytology: Negative, persistent or suspicious', 'unitOfMeasure': 'Percent of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the JCAR017 treated set. Prespecified to be reported for cohort 5 only.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events in Cohort 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'classes': [{'title': 'AEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AEs occurring between LDC and JCAR017 infusion', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'AEs occurring between JCAR017 infusion and Day 30', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'AEs occurring between Day 31 and Day 90', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'AEs occurring between Day 91 and end of study', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From leukapheresis to end of study (up to approximately 63 months)', 'description': "An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the JCAR017 treated set. Prespecified to be reported for cohort 7 only'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs) in Cohort 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'classes': [{'title': 'SAEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'SAEs occurring between LDC and JCAR017 infusion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'SAEs occurring between JCAR017 infusion and Day 30', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'SAEs occurring between Day 31 and Day 90', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'SAEs occurring between Day 91 and end of study', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From leukapheresis to end of study (up to approximately 63 months)', 'description': "A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that:\n\n* Results in death;\n* Is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE);\n* Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay).\n* Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions);\n* Is a congenital anomaly/birth defect;\n* Constitutes an important medical event. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the JCAR017 treated set. Prespecified to be reported for cohort 7 only'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'classes': [{'title': 'Leukocytes (10^9/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Segmented (10^9/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Platelets (10^9/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Activated Partial Thromboplastin Time (sec) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Prothrombin Intl. Normalized Ratio - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Baseline and Day 29 after JCAR017 infusion', 'description': 'JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the JCAR017 treated set with available baseline and Day 29 hematology results. Prespecified to be reported for cohort 7 only'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'classes': [{'title': 'Albumin (g/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate (mmol/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline Phosphatase (U/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Alanine Aminotransferase (U/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate Aminotransferase (U/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin (umol/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine (umol/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides (mmol/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Urate (umol/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Baseline and Day 29 after JCAR017 infusion', 'description': 'JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the JCAR017 treated set with available baseline and Day 29 serum chemistry results. Prespecified to be reported for cohort 7 only'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG001', 'title': 'Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG002', 'title': 'Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG003', 'title': 'Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG004', 'title': 'Cohort 5: Primary Central Nervous System Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'classes': [{'title': 'AEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'AEs occurring between LDC and JCAR017 infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'AEs occurring between JCAR017 infusion and Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'AEs occurring between Day 31 and Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'AEs occurring between Day 91 and end of study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From leukapheresis to end of study (up to approximately 63 months)', 'description': "An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the JCAR017 treated set. Prespecified to be reported for Cohorts 1, 2, 3, 4, and 5 only'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG001', 'title': 'Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG002', 'title': 'Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG003', 'title': 'Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG004', 'title': 'Cohort 5: Primary Central Nervous System Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'classes': [{'title': 'SAEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'SAEs occurring between LDC and JCAR017 infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'SAEs occurring between JCAR017 infusion and Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'SAEs occurring between Day 31 and Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'SAEs occurring between Day 91 and end of study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From leukapheresis to end of study (up to approximately 63 months)', 'description': "A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that:\n\n* Results in death;\n* Is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE);\n* Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay).\n* Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions);\n* Is a congenital anomaly/birth defect;\n* Constitutes an important medical event. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the JCAR017 treated set. Prespecified to be reported for cohorts 1, 2, 3, 4, and 5 only'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG001', 'title': 'Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG002', 'title': 'Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG003', 'title': 'Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG004', 'title': 'Cohort 5: Primary Central Nervous System Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'classes': [{'title': 'Leukocytes (10^9/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Neutrophils, Segmented (10^9/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Platelets (10^9/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Activated Partial Thromboplastin Time (sec) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Prothrombin Intl. Normalized Ratio - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Baseline and Day 29 after JCAR017 infusion', 'description': 'JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 = Mild, Grade 2 =Moderate, Grade 3 =Severe, Grade 4 =Life-threatening, Grade 5 =Death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the JCAR017 treated set with available baseline and Day 29 hematology results. Prespecified to be reported for cohorts 1, 2, 3, 4, and 5 only'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG001', 'title': 'Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG002', 'title': 'Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG003', 'title': 'Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG004', 'title': 'Cohort 5: Primary Central Nervous System Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'classes': [{'title': 'Albumin (g/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Phosphate (mmol/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Alkaline Phosphatase (U/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Alanine Aminotransferase (U/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Aspartate Aminotransferase (U/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Bilirubin (umol/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Creatinine (umol/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Triglycerides (mmol/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Urate (umol/L) - Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Baseline and Day 29 after JCAR017 infusion', 'description': 'JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 = Mild, Grade 2 =Moderate, Grade 3 =Severe, Grade 4 =Life-threatening, Grade 5 =Death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the JCAR017 treated set with available baseline and Day 29 serum chemistry results. Prespecified to be reported for cohorts 1, 2, 3, 4, and 5 only.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR) in Cohort 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'classes': [{'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000', 'lowerLimit': '51.8', 'upperLimit': '99.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)', 'description': 'ORR by Independent Review Committee. ORR is the percent of participants with best overall response of complete response (CR) or partial response (PR).\n\nComplete response via PET-CT:\n\n* Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease\n\nComplete response via CT scan:\n\n* Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter.\n* Nonmeasured lesion: None\n* New lesions: No\n* Bone marrow: Normal\n\nPartial response via PET-CT:\n\n* Lymph nodes/extralymphatic: Score 4, 5b, reduced uptake from baseline\n* New lesions: None\n* Bone marrow: Residual uptake higher than normal, reduced from baseline\n\nPartial response via CT scan:\n\n* Lymph nodes/extralymphatic: 50% decrease in sum of diameters of \\<= 6 target measurable nodes/extranodal sites\n* Nonmeasured lesion: None/normal\n* Organ enlargement: Spleen length decreased \\> 50%\n* New lesions: No', 'unitOfMeasure': 'Percent of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the JCAR017 treated set. Prespecified to be reported for cohort 7 only.'}, {'type': 'SECONDARY', 'title': 'Complete Response Rate (CRR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG001', 'title': 'Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG002', 'title': 'Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG003', 'title': 'Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG004', 'title': 'Cohort 5: Primary Central Nervous System Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG005', 'title': 'Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '18.6', 'upperLimit': '51.0'}, {'value': '48.1', 'groupId': 'OG001', 'lowerLimit': '28.7', 'upperLimit': '68.1'}, {'value': '50.0', 'groupId': 'OG002', 'lowerLimit': '18.7', 'upperLimit': '81.3'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '88.9', 'groupId': 'OG005', 'lowerLimit': '51.8', 'upperLimit': '99.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)', 'description': 'Complete response rate is defined as percentage of participants achieving a best overall response of complete response.\n\nComplete response via PET-CT:\n\n* Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease\n\nComplete response via CT scan:\n\n* Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter.\n* Nonmeasured lesion: None\n* New lesions: No\n* Bone marrow: Normal\n\nComplete response (CR) (Cohort 5):\n\n* Brain imaging: No contrast enhancement\n* Corticosteroid dose: None\n* Eye examination: Normal\n* Cerebrospinal fluid cytology: Negative\n\nComplete response unconfirmed (CRu) (Cohort 5):\n\n* Brain imaging: No contrast enhancement, Minimal abnormality\n* Corticosteroid dose: Any\n* Eye examination: Normal, minor RPE abnormality\n* Cerebrospinal fluid cytology: Negative', 'unitOfMeasure': 'Percent of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the JCAR017 treated set.'}, {'type': 'SECONDARY', 'title': 'Event Free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG001', 'title': 'Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG002', 'title': 'Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG003', 'title': 'Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG004', 'title': 'Cohort 5: Primary Central Nervous System Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG005', 'title': 'Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.99', 'groupId': 'OG000', 'lowerLimit': '2.60', 'upperLimit': '5.22'}, {'value': '3.12', 'groupId': 'OG001', 'lowerLimit': '1.97', 'upperLimit': '7.36'}, {'value': '6.33', 'comment': 'Insufficient number of events to calculate upper limit of the CI using the K-M method.', 'groupId': 'OG002', 'lowerLimit': '0.56', 'upperLimit': 'NA'}, {'value': '23.95', 'groupId': 'OG003', 'lowerLimit': '23.95', 'upperLimit': '23.95'}, {'value': '14.23', 'groupId': 'OG004', 'lowerLimit': '0.76', 'upperLimit': '24.02'}, {'value': 'NA', 'comment': 'Insufficient number of events to calculate median and upper limit of the CI using the K-M method.', 'groupId': 'OG005', 'lowerLimit': '5.65', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From JCAR017 infusion to death due to any reason, progressive disease, or starting a new anticancer therapy (up to approximately 63 months).', 'description': 'Event-free survival is from JCAR017 infusion to death from any cause, progressive disease, or starting a new anticancer therapy. If a participant did not have an EFS event prior to data cutoff, EFS was censored at last disease assessment.\n\nProgressive disease (PD):\n\n* Target nodes/nodal masses: PPD progression.\n* Extranodal lesion: LDi \\> 1.5 cm and increase by ≥ 50% from PPD nadir.\n* Splenomegaly: \\> 50% of prior increase from baseline or by at least 2 cm from baseline.\n* Nonmeasured lesions: New or clear progression.\n* New lesions: Regrowth of previously resolved lesions.\n* Bone marrow: New or recurrent\n\nProgressive Disease (Cohort 5):\n\n* Brain imaging: \\> 25% increase in enhancing lesion from baseline or best response.\n* Eye Exam: Increased vitreous cell counts or progressive retinal or optic nerve infiltration.\n* New lesion or site of disease', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the JCAR017 treated set.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) Using European Medicines Agency (EMA) Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG001', 'title': 'Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG002', 'title': 'Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG003', 'title': 'Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG004', 'title': 'Cohort 5: Primary Central Nervous System Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG005', 'title': 'Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.99', 'groupId': 'OG000', 'lowerLimit': '2.76', 'upperLimit': '5.22'}, {'value': '3.12', 'groupId': 'OG001', 'lowerLimit': '1.97', 'upperLimit': '7.36'}, {'value': '6.33', 'comment': 'Insufficient number of events to calculate upper limit of the CI using the K-M method.', 'groupId': 'OG002', 'lowerLimit': '0.56', 'upperLimit': 'NA'}, {'value': '14.23', 'groupId': 'OG003', 'lowerLimit': '0.76', 'upperLimit': '24.02'}, {'value': '23.95', 'groupId': 'OG004', 'lowerLimit': '23.95', 'upperLimit': '23.95'}, {'value': 'NA', 'comment': 'Insufficient number of events to calculate median and upper limit of the CI using the K-M method.', 'groupId': 'OG005', 'lowerLimit': '5.65', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From JCAR017 infusion to progressive disease or death due to any reason, whichever occurred first (up to approximately 63 months)', 'description': 'Progression-free survival is defined as the interval from the date of JCAR017 infusion to progressive disease or death due to any cause, whichever occurred first. Per European Medicines Agency (EMA) criteria, participants who did not experience progressive disease and who did not die before the data cutoff date were censored at the time of the last visit with adequate response assessment when the participants were known not to have progressed.\n\nEstimated using Kaplan-Meier product-limit estimates.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the JCAR017 treated set.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG001', 'title': 'Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG002', 'title': 'Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG003', 'title': 'Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG004', 'title': 'Cohort 5: Primary Central Nervous System Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG005', 'title': 'Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'classes': [{'categories': [{'measurements': [{'value': '15.84', 'groupId': 'OG000', 'lowerLimit': '5.82', 'upperLimit': '23.95'}, {'value': '16.82', 'comment': 'Insufficient number of events to calculate upper limit of the CI using the K-M method.', 'groupId': 'OG001', 'lowerLimit': '4.27', 'upperLimit': 'NA'}, {'value': '14.72', 'comment': 'Insufficient number of events to calculate upper limit of the CI using the K-M method.', 'groupId': 'OG002', 'lowerLimit': '1.71', 'upperLimit': 'NA'}, {'value': '31.74', 'groupId': 'OG003', 'lowerLimit': '31.74', 'upperLimit': '31.74'}, {'value': '14.23', 'comment': 'Insufficient number of events to calculate upper limit of the CI using the K-M method.', 'groupId': 'OG004', 'lowerLimit': '4.30', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Insufficient number of events to calculate median and upper limit of the CI using the K-M method.', 'groupId': 'OG005', 'lowerLimit': '11.60', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the date of JCAR017 infusion to the date of death due to any reason (up to approximately 63 months).', 'description': 'Overall survival is defined as the interval from the date of JCAR017 infusion to the date of death due to any reason. Data from surviving participants was censored at the last time that the participant was known to be alive.\n\nEstimated using Kaplan-Meier product-limit estimates.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the JCAR017 treated set.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG001', 'title': 'Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG002', 'title': 'Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG003', 'title': 'Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG004', 'title': 'Cohort 5: Primary Central Nervous System Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG005', 'title': 'Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.83', 'groupId': 'OG000', 'lowerLimit': '2.07', 'upperLimit': '17.05'}, {'value': '3.91', 'comment': 'Insufficient number of events to calculate upper limit of the CI using the K-M method.', 'groupId': 'OG001', 'lowerLimit': '1.87', 'upperLimit': 'NA'}, {'value': '9.07', 'comment': 'Insufficient number of events to calculate upper limit of the CI using the K-M method.', 'groupId': 'OG002', 'lowerLimit': '2.04', 'upperLimit': 'NA'}, {'value': '17.97', 'groupId': 'OG003', 'lowerLimit': '17.97', 'upperLimit': '17.97'}, {'value': '17.63', 'groupId': 'OG004', 'lowerLimit': '2.46', 'upperLimit': '23.10'}, {'value': 'NA', 'comment': 'Insufficient number of events to calculate median and upper limit of the CI using the K-M method.', 'groupId': 'OG005', 'lowerLimit': '2.69', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From JCAR017 infusion until disease progression, death due to any reason, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)', 'description': 'DOR is from first response (complete response (CR), CR unconfirmed (CRu) or partial response (PR)) to progression (PD) or death. Those without PD or death were censored at the last assessment.\n\nCR via PET-CT: Lymph/extralymph: Score 1/2/3a w/w-out resid mass, no new lesions, No FDG-avid disease in bone marrow (BM) CR via CT scan: Lymph/extralymph: Target/nodal ≤ 1.5 cm, no new lesions, normal BM CR Cohort 5: No contrast enhance, no corticosteroid, normal eye exam, neg CSF cytology CRu Cohort 5: No contrast enhance, min abnorm, normal eye exam, neg CSF cytology PR via PET-CT: Lymph/extralymph: Score 4/5b, red uptake, no new lesions, resid uptake incr, reduced in BM PR via CT scan: Lymph/extralymph: 50% decr in sum of diam ≤ 6 target/extranodal, no new/nonmeasured lesions, Organ enlarge: Spleen decr \\> 50% PR Cohort 5: 50% decr in enhancing tumor, no contrast enhance, Eye exam: Minor abnorm, decr in vitreous cells/retinal infiltrate, negative, persist or suspic CSF cytology.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the JCAR017 treated set who achieved a best overall response of complete response (and/ or CRu in cohort 5) or partial response/ remission.'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration (Cmax) of JCAR017 by qPCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG001', 'title': 'Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG002', 'title': 'Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG003', 'title': 'Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG004', 'title': 'Cohort 5: Primary Central Nervous System Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG005', 'title': 'Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'classes': [{'categories': [{'measurements': [{'value': '23132.1', 'spread': '434.6', 'groupId': 'OG000'}, {'value': '21960.0', 'spread': '278.1', 'groupId': 'OG001'}, {'value': '17337.8', 'spread': '894.4', 'groupId': 'OG002'}, {'value': '51121.0', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate Geometric Coefficient of Variation.', 'groupId': 'OG003'}, {'value': '7661.6', 'spread': '1730.0', 'groupId': 'OG004'}, {'value': '32027.1', 'spread': '101.4', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At baseline and up until 24 months post JCAR017 infusion', 'description': 'Cmax is the maximum or peak concentration of drug reached in the plasma following a dose of the drug.\n\nQuantitative polymerase chain reaction (qPCR) was used to determine Cmax by detecting the JCAR017 transgene.\n\nBaseline is defined as the last available recorded value on or prior to the date of JCAR017 infusion.', 'unitOfMeasure': 'Copies/ug', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the JCAR017 treated set with baseline and on-study PK measurements.'}, {'type': 'SECONDARY', 'title': 'Time to Peak Concentration (Tmax) of JCAR017 by qPCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG001', 'title': 'Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG002', 'title': 'Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG003', 'title': 'Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG004', 'title': 'Cohort 5: Primary Central Nervous System Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG005', 'title': 'Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'classes': [{'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '28.0'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '14.0'}, {'value': '84.1', 'groupId': 'OG002', 'lowerLimit': '7.0', 'upperLimit': '733.0'}, {'value': '10.0', 'groupId': 'OG003', 'lowerLimit': '10.0', 'upperLimit': '10.0'}, {'value': '9.0', 'groupId': 'OG004', 'lowerLimit': '7.0', 'upperLimit': '14.0'}, {'value': '12.2', 'groupId': 'OG005', 'lowerLimit': '10.0', 'upperLimit': '21.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline and up until 24 months post JCAR017 infusion', 'description': 'Time to maximum concentration (Tmax) is the time it takes for a drug to reach the maximum concentration (Cmax) after administration.\n\nQuantitative polymerase chain reaction (qPCR) was used to determine Tmax by detecting the JCAR017 transgene.\n\nBaseline is defined as the last available recorded value on or prior to the date of JCAR017 infusion.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the JCAR017 treated set with baseline and on-study PK measurements.'}, {'type': 'SECONDARY', 'title': 'Total Exposure to JCAR017 as Measured by Area Under the Curve (AUC) of JCAR017 by qPCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG001', 'title': 'Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG002', 'title': 'Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG003', 'title': 'Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG004', 'title': 'Cohort 5: Primary Central Nervous System Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG005', 'title': 'Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'classes': [{'categories': [{'measurements': [{'value': '185586.667', 'spread': '325.6', 'groupId': 'OG000'}, {'value': '157499.362', 'spread': '211.9', 'groupId': 'OG001'}, {'value': '134819.085', 'spread': '1268.9', 'groupId': 'OG002'}, {'value': '286119.439', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate Geometric Coefficient of Variation.', 'groupId': 'OG003'}, {'value': '64945.715', 'spread': '1345.7', 'groupId': 'OG004'}, {'value': '199731.737', 'spread': '136.8', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At baseline and up until 24 months post JCAR017 infusion', 'description': 'Area Under the Curve (AUC) represents the total exposure of participants to study drug.\n\nQuantitative polymerase chain reaction (qPCR) was used to determine AUC by detecting the JCAR017 transgene.\n\nBaseline is defined as the last available recorded value on or prior to the date of JCAR017 infusion.', 'unitOfMeasure': 'Days*copies/ug', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the JCAR017 treated set with baseline and on-study PK measurements.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG001', 'title': 'Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG002', 'title': 'Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG003', 'title': 'Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG004', 'title': 'Cohort 5: Primary Central Nervous System Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG005', 'title': 'Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '88.2', 'groupId': 'OG000'}, {'value': '95.2', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '80.0', 'groupId': 'OG004'}, {'value': '100.0', 'groupId': 'OG005'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '62.5', 'groupId': 'OG005'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '37.5', 'groupId': 'OG005'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '45.5', 'groupId': 'OG001'}, {'value': '71.4', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '16.7', 'groupId': 'OG005'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}, {'value': '60.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '25.0', 'groupId': 'OG005'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '66.7', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}, {'value': '75.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '20.0', 'groupId': 'OG005'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '20.0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 29 and Months 2, 3, 6, 9, 12, 18, and 24 post JCAR017 infusion.', 'description': 'Persistence is defined as a transgene count greater than or equal to the lower limit of detection (LLOD) of 5 copies per reaction. Data obtained after the start of a new anti-cancer therapy were excluded. qPCR = Quantitative polymerase chain reaction.', 'unitOfMeasure': 'Percent of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the JCAR017 treated set with baseline and on-study JCAR017 transgene results.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG001', 'title': 'Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG002', 'title': 'Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG003', 'title': 'Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG004', 'title': 'Cohort 5: Primary Central Nervous System Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG005', 'title': 'Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'classes': [{'title': 'Global Health Status: Change from baseline Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-4.41', 'spread': '17.070', 'groupId': 'OG000'}, {'value': '-5.07', 'spread': '17.898', 'groupId': 'OG001'}, {'value': '-6.67', 'spread': '10.244', 'groupId': 'OG002'}, {'value': '-8.33', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '8.33', 'spread': '25.685', 'groupId': 'OG004'}, {'value': '-7.41', 'spread': '12.108', 'groupId': 'OG005'}]}]}, {'title': 'Global Health Status: Change from baseline Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.26', 'spread': '14.301', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '18.002', 'groupId': 'OG001'}, {'value': '-4.17', 'spread': '17.236', 'groupId': 'OG002'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '16.67', 'spread': '11.785', 'groupId': 'OG004'}, {'value': '-1.85', 'spread': '14.299', 'groupId': 'OG005'}]}]}, {'title': 'Global Health Status: Change from baseline Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5.00', 'spread': '14.778', 'groupId': 'OG000'}, {'value': '7.84', 'spread': '17.547', 'groupId': 'OG001'}, {'value': '4.17', 'spread': '16.457', 'groupId': 'OG002'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '13.89', 'spread': '26.788', 'groupId': 'OG004'}, {'value': '9.26', 'spread': '8.784', 'groupId': 'OG005'}]}]}, {'title': 'Global Health Status: Change from baseline Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.47', 'spread': '14.766', 'groupId': 'OG000'}, {'value': '1.28', 'spread': '22.527', 'groupId': 'OG001'}, {'value': '-5.95', 'spread': '17.817', 'groupId': 'OG002'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '22.22', 'spread': '41.107', 'groupId': 'OG004'}, {'value': '4.63', 'spread': '8.448', 'groupId': 'OG005'}]}]}, {'title': 'Global Health Status: Change from baseline Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '6.94', 'spread': '13.685', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '23.332', 'groupId': 'OG001'}, {'value': '-13.10', 'spread': '35.635', 'groupId': 'OG002'}, {'value': '-16.67', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '25.00', 'spread': '22.048', 'groupId': 'OG004'}, {'value': '2.78', 'spread': '8.607', 'groupId': 'OG005'}]}]}, {'title': 'Global Health Status: Change from baseline Day 270', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '6.25', 'spread': '20.140', 'groupId': 'OG000'}, {'value': '9.72', 'spread': '9.742', 'groupId': 'OG001'}, {'value': '-3.33', 'spread': '26.745', 'groupId': 'OG002'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '25.00', 'spread': '22.048', 'groupId': 'OG004'}, {'value': '3.33', 'spread': '9.501', 'groupId': 'OG005'}]}]}, {'title': 'Global Health Status: Change from baseline Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-6.67', 'spread': '20.337', 'groupId': 'OG000'}, {'value': '3.57', 'spread': '11.664', 'groupId': 'OG001'}, {'value': '-12.50', 'spread': '25.909', 'groupId': 'OG002'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '30.56', 'spread': '26.788', 'groupId': 'OG004'}, {'value': '3.33', 'spread': '7.454', 'groupId': 'OG005'}]}]}, {'title': 'Global Health Status: Change from baseline Day 545', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-6.48', 'spread': '18.530', 'groupId': 'OG000'}, {'value': '3.57', 'spread': '26.726', 'groupId': 'OG001'}, {'value': '-5.56', 'spread': '24.056', 'groupId': 'OG002'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '0.00', 'spread': '47.140', 'groupId': 'OG004'}, {'value': '1.67', 'spread': '9.129', 'groupId': 'OG005'}]}]}, {'title': 'Global Health Status: Change from baseline Day 730', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-11.11', 'spread': '12.975', 'groupId': 'OG000'}, {'value': '-4.17', 'spread': '12.638', 'groupId': 'OG001'}, {'value': '-6.25', 'spread': '7.979', 'groupId': 'OG002'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '20.83', 'spread': '29.463', 'groupId': 'OG004'}, {'value': '-2.08', 'spread': '21.916', 'groupId': 'OG005'}]}]}, {'title': 'Physical Functioning: Change from baseline Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-3.33', 'spread': '20.970', 'groupId': 'OG000'}, {'value': '-6.09', 'spread': '21.074', 'groupId': 'OG001'}, {'value': '-3.33', 'spread': '11.440', 'groupId': 'OG002'}, {'value': '-6.67', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '-2.67', 'spread': '19.777', 'groupId': 'OG004'}, {'value': '-3.70', 'spread': '14.948', 'groupId': 'OG005'}]}]}, {'title': 'Physical Functioning: Change from baseline Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-2.63', 'spread': '18.555', 'groupId': 'OG000'}, {'value': '-4.21', 'spread': '10.706', 'groupId': 'OG001'}, {'value': '-10.00', 'spread': '14.824', 'groupId': 'OG002'}, {'value': '6.67', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '-8.33', 'spread': '16.667', 'groupId': 'OG004'}, {'value': '-8.15', 'spread': '18.493', 'groupId': 'OG005'}]}]}, {'title': 'Physical Functioning: Change from baseline Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.11', 'spread': '15.135', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '21.275', 'groupId': 'OG001'}, {'value': '-4.44', 'spread': '15.587', 'groupId': 'OG002'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '-2.22', 'spread': '10.184', 'groupId': 'OG004'}, {'value': '-2.96', 'spread': '10.062', 'groupId': 'OG005'}]}]}, {'title': 'Physical Functioning: Change from baseline Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.46', 'spread': '16.781', 'groupId': 'OG000'}, {'value': '3.59', 'spread': '12.054', 'groupId': 'OG001'}, {'value': '-5.71', 'spread': '11.174', 'groupId': 'OG002'}, {'value': '6.67', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '11.11', 'spread': '23.413', 'groupId': 'OG004'}, {'value': '-0.74', 'spread': '18.692', 'groupId': 'OG005'}]}]}, {'title': 'Physical Functioning: Change from baseline Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '7.78', 'spread': '12.975', 'groupId': 'OG000'}, {'value': '-8.33', 'spread': '31.219', 'groupId': 'OG001'}, {'value': '-5.71', 'spread': '19.024', 'groupId': 'OG002'}, {'value': '-6.67', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '15.56', 'spread': '27.756', 'groupId': 'OG004'}, {'value': '-2.22', 'spread': '24.825', 'groupId': 'OG005'}]}]}, {'title': 'Physical Functioning: Change from baseline Day 270', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.33', 'spread': '10.050', 'groupId': 'OG000'}, {'value': '1.11', 'spread': '19.052', 'groupId': 'OG001'}, {'value': '-2.67', 'spread': '22.410', 'groupId': 'OG002'}, {'value': '6.67', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '24.44', 'spread': '27.756', 'groupId': 'OG004'}, {'value': '-6.67', 'spread': '31.972', 'groupId': 'OG005'}]}]}, {'title': 'Physical Functioning: Change from baseline Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.67', 'spread': '16.163', 'groupId': 'OG000'}, {'value': '0.95', 'spread': '16.069', 'groupId': 'OG001'}, {'value': '-16.67', 'spread': '20.000', 'groupId': 'OG002'}, {'value': '6.67', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '22.22', 'spread': '26.943', 'groupId': 'OG004'}, {'value': '5.33', 'spread': '11.926', 'groupId': 'OG005'}]}]}, {'title': 'Physical Functioning: Change from baseline Day 545', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-3.70', 'spread': '26.690', 'groupId': 'OG000'}, {'value': '-1.90', 'spread': '19.135', 'groupId': 'OG001'}, {'value': '-13.33', 'spread': '23.094', 'groupId': 'OG002'}, {'value': '6.67', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '13.33', 'spread': '47.140', 'groupId': 'OG004'}, {'value': '9.33', 'spread': '11.155', 'groupId': 'OG005'}]}]}, {'title': 'Physical Functioning: Change from baseline Day 730', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.11', 'spread': '15.785', 'groupId': 'OG000'}, {'value': '-8.89', 'spread': '28.493', 'groupId': 'OG001'}, {'value': '-3.33', 'spread': '8.607', 'groupId': 'OG002'}, {'value': '6.67', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '3.33', 'spread': '42.426', 'groupId': 'OG004'}, {'value': '-3.33', 'spread': '11.547', 'groupId': 'OG005'}]}]}, {'title': 'Cognitive Functioning: Change from baseline Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-3.43', 'spread': '17.301', 'groupId': 'OG000'}, {'value': '-3.62', 'spread': '17.376', 'groupId': 'OG001'}, {'value': '-1.67', 'spread': '9.461', 'groupId': 'OG002'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '-3.33', 'spread': '13.944', 'groupId': 'OG004'}, {'value': '-1.85', 'spread': '10.015', 'groupId': 'OG005'}]}]}, {'title': 'Cognitive Functioning: Change from baseline Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-2.53', 'spread': '16.203', 'groupId': 'OG000'}, {'value': '3.51', 'spread': '14.250', 'groupId': 'OG001'}, {'value': '3.33', 'spread': '13.147', 'groupId': 'OG002'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '8.33', 'spread': '21.517', 'groupId': 'OG004'}, {'value': '-7.41', 'spread': '12.108', 'groupId': 'OG005'}]}]}, {'title': 'Cognitive Functioning: Change from baseline Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.78', 'spread': '12.444', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '10.978', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '27.889', 'groupId': 'OG002'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '33.33', 'spread': '44.096', 'groupId': 'OG004'}, {'value': '-1.85', 'spread': '13.029', 'groupId': 'OG005'}]}]}, {'title': 'Cognitive Functioning: Change from baseline Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '13.074', 'groupId': 'OG000'}, {'value': '-1.28', 'spread': '12.659', 'groupId': 'OG001'}, {'value': '4.76', 'spread': '20.893', 'groupId': 'OG002'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '11.11', 'spread': '19.245', 'groupId': 'OG004'}, {'value': '0.00', 'spread': '8.333', 'groupId': 'OG005'}]}]}, {'title': 'Cognitive Functioning: Change from baseline Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-2.78', 'spread': '15.624', 'groupId': 'OG000'}, {'value': '-2.08', 'spread': '5.893', 'groupId': 'OG001'}, {'value': '11.90', 'spread': '20.893', 'groupId': 'OG002'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '16.67', 'spread': '28.868', 'groupId': 'OG004'}, {'value': '-5.56', 'spread': '8.607', 'groupId': 'OG005'}]}]}, {'title': 'Cognitive Functioning: Change from baseline Day 270', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '22.473', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.000', 'groupId': 'OG001'}, {'value': '3.33', 'spread': '13.944', 'groupId': 'OG002'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '33.33', 'spread': '44.096', 'groupId': 'OG004'}, {'value': '3.33', 'spread': '7.454', 'groupId': 'OG005'}]}]}, {'title': 'Cognitive Functioning: Change from baseline Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-11.67', 'spread': '22.292', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.000', 'groupId': 'OG001'}, {'value': '-4.17', 'spread': '8.333', 'groupId': 'OG002'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '22.22', 'spread': '38.490', 'groupId': 'OG004'}, {'value': '6.67', 'spread': '9.129', 'groupId': 'OG005'}]}]}, {'title': 'Cognitive Functioning: Change from baseline Day 545', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-7.41', 'spread': '18.840', 'groupId': 'OG000'}, {'value': '2.38', 'spread': '11.501', 'groupId': 'OG001'}, {'value': '-5.56', 'spread': '19.245', 'groupId': 'OG002'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '-41.67', 'spread': '82.496', 'groupId': 'OG004'}, {'value': '3.33', 'spread': '7.454', 'groupId': 'OG005'}]}]}, {'title': 'Cognitive Functioning: Change from baseline Day 730', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.39', 'spread': '18.060', 'groupId': 'OG000'}, {'value': '-5.56', 'spread': '8.607', 'groupId': 'OG001'}, {'value': '-4.17', 'spread': '15.957', 'groupId': 'OG002'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '-16.67', 'spread': '23.570', 'groupId': 'OG004'}, {'value': '-4.17', 'spread': '8.333', 'groupId': 'OG005'}]}]}, {'title': 'Fatigue: Change from baseline Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.63', 'spread': '26.959', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '16.173', 'groupId': 'OG001'}, {'value': '3.33', 'spread': '20.320', 'groupId': 'OG002'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '-20.00', 'spread': '30.832', 'groupId': 'OG004'}, {'value': '1.23', 'spread': '18.794', 'groupId': 'OG005'}]}]}, {'title': 'Fatigue: Change from baseline Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.03', 'spread': '24.418', 'groupId': 'OG000'}, {'value': '2.34', 'spread': '12.046', 'groupId': 'OG001'}, {'value': '5.56', 'spread': '17.568', 'groupId': 'OG002'}, {'value': '-11.11', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '-13.89', 'spread': '27.778', 'groupId': 'OG004'}, {'value': '6.17', 'spread': '14.815', 'groupId': 'OG005'}]}]}, {'title': 'Fatigue: Change from baseline Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-9.63', 'spread': '18.623', 'groupId': 'OG000'}, {'value': '-1.31', 'spread': '20.743', 'groupId': 'OG001'}, {'value': '3.70', 'spread': '31.946', 'groupId': 'OG002'}, {'value': '11.11', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '-14.81', 'spread': '35.717', 'groupId': 'OG004'}, {'value': '0.00', 'spread': '17.568', 'groupId': 'OG005'}]}]}, {'title': 'Fatigue: Change from baseline Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-4.53', 'spread': '19.795', 'groupId': 'OG000'}, {'value': '-4.27', 'spread': '17.881', 'groupId': 'OG001'}, {'value': '4.76', 'spread': '35.635', 'groupId': 'OG002'}, {'value': '-11.11', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '-37.04', 'spread': '12.830', 'groupId': 'OG004'}, {'value': '-3.70', 'spread': '22.906', 'groupId': 'OG005'}]}]}, {'title': 'Fatigue: Change from baseline Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-8.33', 'spread': '21.254', 'groupId': 'OG000'}, {'value': '2.78', 'spread': '34.503', 'groupId': 'OG001'}, {'value': '-4.76', 'spread': '38.946', 'groupId': 'OG002'}, {'value': '22.22', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '-37.04', 'spread': '23.130', 'groupId': 'OG004'}, {'value': '0.00', 'spread': '33.702', 'groupId': 'OG005'}]}]}, {'title': 'Fatigue: Change from baseline Day 270', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-9.26', 'spread': '15.594', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '22.222', 'groupId': 'OG001'}, {'value': '-6.67', 'spread': '14.907', 'groupId': 'OG002'}, {'value': '-11.11', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '-29.63', 'spread': '42.066', 'groupId': 'OG004'}, {'value': '-2.22', 'spread': '34.605', 'groupId': 'OG005'}]}]}, {'title': 'Fatigue: Change from baseline Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-3.33', 'spread': '14.861', 'groupId': 'OG000'}, {'value': '-4.76', 'spread': '20.141', 'groupId': 'OG001'}, {'value': '13.89', 'spread': '33.179', 'groupId': 'OG002'}, {'value': '-11.11', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '-44.44', 'spread': '22.222', 'groupId': 'OG004'}, {'value': '-13.33', 'spread': '14.487', 'groupId': 'OG005'}]}]}, {'title': 'Fatigue: Change from baseline Day 545', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.94', 'spread': '25.526', 'groupId': 'OG000'}, {'value': '-1.59', 'spread': '19.698', 'groupId': 'OG001'}, {'value': '-3.70', 'spread': '27.962', 'groupId': 'OG002'}, {'value': '-11.11', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '-5.56', 'spread': '23.570', 'groupId': 'OG004'}, {'value': '-11.11', 'spread': '15.713', 'groupId': 'OG005'}]}]}, {'title': 'Fatigue: Change from baseline Day 730', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.93', 'spread': '22.947', 'groupId': 'OG000'}, {'value': '3.70', 'spread': '9.072', 'groupId': 'OG001'}, {'value': '5.56', 'spread': '14.344', 'groupId': 'OG002'}, {'value': '-11.11', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '-16.67', 'spread': '7.857', 'groupId': 'OG004'}, {'value': '-8.33', 'spread': '16.667', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and Day 1, 29, 60, 90, 180, 270, 365, 545, and 730 post JCAR017 infusion.', 'description': 'The EORTC QLQ-C30 consists of five functional scales (physical, role, emotional, cognitive, social), three symptom scales (fatigue, nausea/vomiting, pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). The questionnaire is scored on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much. The raw score is the average of the items contributing to the scale. The final scores are calculated via linear transformation of raw scores and range from 0 to 100. For functional scales higher scores indicate better QoL. For symptom scales and single items lower scores indicate fewer symptoms, i.e. better QoL. Baseline the last available recorded scores on or prior to the date of JCAR017 infusion. Only global health, fatigue, physical and cognitive functioning subscales were assessed.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the JCAR017-treated set with completed baseline questionnaires and with at least one completed post-baseline questionnaire.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma "Additional Concerns" Subscale (FACT-LymS) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG001', 'title': 'Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG002', 'title': 'Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG003', 'title': 'Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG004', 'title': 'Cohort 5: Primary Central Nervous System Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'OG005', 'title': 'Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'classes': [{'title': 'Change from baseline Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '8.17', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '7.05', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '5.92', 'groupId': 'OG002'}, {'value': '1.0', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '-4.0', 'spread': '6.52', 'groupId': 'OG004'}, {'value': '-1.2', 'spread': '11.08', 'groupId': 'OG005'}]}]}, {'title': 'Change from baseline Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '7.14', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '4.56', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '7.24', 'groupId': 'OG002'}, {'value': '-4.0', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '-6.5', 'spread': '8.10', 'groupId': 'OG004'}, {'value': '1.0', 'spread': '9.08', 'groupId': 'OG005'}]}]}, {'title': 'Change from baseline Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '5.42', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '4.20', 'groupId': 'OG001'}, {'value': '-3.3', 'spread': '9.99', 'groupId': 'OG002'}, {'value': '-4.0', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '-4.7', 'spread': '8.33', 'groupId': 'OG004'}, {'value': '-0.4', 'spread': '9.95', 'groupId': 'OG005'}]}]}, {'title': 'Change from baseline Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '5.42', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '3.83', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '9.25', 'groupId': 'OG002'}, {'value': '-5.0', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '-6.7', 'spread': '8.50', 'groupId': 'OG004'}, {'value': '-1.7', 'spread': '8.67', 'groupId': 'OG005'}]}]}, {'title': 'Change from baseline Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '5.14', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '5.65', 'groupId': 'OG001'}, {'value': '-3.6', 'spread': '10.20', 'groupId': 'OG002'}, {'value': '2.0', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '-8.0', 'spread': '7.00', 'groupId': 'OG004'}, {'value': '1.0', 'spread': '7.27', 'groupId': 'OG005'}]}]}, {'title': 'Change from baseline Day 270', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '6.78', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '2.25', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '10.07', 'groupId': 'OG002'}, {'value': '-8.0', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '-10.00', 'spread': '12.53', 'groupId': 'OG004'}, {'value': '2.4', 'spread': '5.22', 'groupId': 'OG005'}]}]}, {'title': 'Change from baseline Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '7.01', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '3.30', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '12.03', 'groupId': 'OG002'}, {'value': '-6.0', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '-6.7', 'spread': '10.69', 'groupId': 'OG004'}, {'value': '1.4', 'spread': '7.33', 'groupId': 'OG005'}]}]}, {'title': 'Change from baseline Day 545', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '7.14', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '4.35', 'groupId': 'OG001'}, {'value': '-4.7', 'spread': '4.16', 'groupId': 'OG002'}, {'value': '-3.0', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '3.5', 'spread': '6.36', 'groupId': 'OG004'}, {'value': '-1.0', 'spread': '4.85', 'groupId': 'OG005'}]}]}, {'title': 'Change from baseline Day 730', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '7.12', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '1.33', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '5.32', 'groupId': 'OG002'}, {'value': '-2.0', 'spread': 'NA', 'comment': 'Insufficient number of participants to calculate standard deviation.', 'groupId': 'OG003'}, {'value': '-1.5', 'spread': '12.02', 'groupId': 'OG004'}, {'value': '-1.5', 'spread': '1.29', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and Day 1, 29, 60, 90, 180, 270, 365, 545, and 730 post JCAR017 infusion.', 'description': 'The Functional Assessment of Cancer Treatment-Lymphoma "Additional concerns" subscale (FACT-LymS) consists of the FACT-General scale and a 15-item lymphoma-specific additional concerns subscale (LYM). This scale addresses symptoms and functional limitations that are important to lymphoma patients. Only the LYM subscale was administered in this study. 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. Lower scores indicate better health outcomes. Baseline the last available recorded scores on or prior to the date of JCAR017 infusion.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the JCAR017-treated set with completed baseline questionnaires and with at least one completed post-baseline questionnaire.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'FG001', 'title': 'Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'FG002', 'title': 'Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'FG003', 'title': 'Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'FG004', 'title': 'Cohort 5: Primary Central Nervous System Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'FG005', 'title': 'Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}], 'periods': [{'title': 'Pre-Treatment Period - Leukapheresis', 'milestones': [{'type': 'STARTED', 'comment': 'Underwent Leukapheresis', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}, {'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'comment': 'Started lymphodepleting chemotherapy.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'JCAR017 Treated Set', 'comment': 'Received conforming JCAR017 cell product.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Participant Withdrew from Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'During the pretreatment period participants underwent leukapheresis to enable JCAR017 cell product generation. Upon successful JCAR017 cell product generation, participants entered the treatment period and received lymphodepleting chemotherapy followed by infusion of JCAR017.\n\nCohort 6 was planned but subsequently removed from the study. No participants were enrolled into Cohort 6.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '113', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'BG001', 'title': 'Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'BG002', 'title': 'Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'BG003', 'title': 'Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'BG004', 'title': 'Cohort 5: Primary Central Nervous System Lymphoma', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'BG005', 'title': 'Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting', 'description': 'JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.2', 'spread': '10.60', 'groupId': 'BG000'}, {'value': '73.3', 'spread': '5.50', 'groupId': 'BG001'}, {'value': '57.6', 'spread': '10.08', 'groupId': 'BG002'}, {'value': '63.5', 'spread': '21.11', 'groupId': 'BG003'}, {'value': '57.0', 'spread': '5.74', 'groupId': 'BG004'}, {'value': '58.1', 'spread': '12.47', 'groupId': 'BG005'}, {'value': '63.3', 'spread': '11.56', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '42', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '71', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '79', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '71', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '25', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-12', 'size': 3346532, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-21T08:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-20', 'studyFirstSubmitDate': '2018-03-26', 'resultsFirstSubmitDate': '2024-11-21', 'studyFirstSubmitQcDate': '2018-03-26', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-20', 'studyFirstPostDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3', 'timeFrame': 'From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)', 'description': 'Overall response rate (ORR) by Independent Review Committee (Cohorts 1, 2, 3). ORR is the percent of participants with best overall response of complete response (CR) or partial response (PR).\n\nComplete response via PET-CT:\n\n* Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease\n\nComplete response via CT scan:\n\n* Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter.\n* Nonmeasured lesion: No\n* New lesions: No\n* Bone marrow: Normal\n\nPartial response via PET-CT:\n\n* Lymph nodes/extralymphatic: Score 4, 5b, reduced uptake from baseline\n* New lesions: No\n* Bone marrow: Residual uptake higher than normal, reduced from baseline\n\nPartial response via CT scan:\n\n* Lymph nodes/extralymphatic: 50% decrease in sum of diameters of \\<= 6 target measurable nodes/extranodal sites\n* Nonmeasured lesion: No\n* Organ enlargement: Spleen length decreased \\> 50%\n* New lesions: No'}, {'measure': 'Overall Response Rate (ORR) Per Investigator in Cohort 4', 'timeFrame': 'From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)', 'description': 'Overall response rate (ORR) is the percent of participants with best overall response of complete response (CR) or partial response (PR).\n\nComplete response via PET-CT:\n\n* Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease\n\nComplete response via CT scan:\n\n* Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter.\n* Nonmeasured lesion: None\n* New lesions: No\n* Bone marrow: Normal\n\nPartial response via PET-CT:\n\n* Lymph nodes/extralymphatic: Score 4, 5b, reduced uptake from baseline\n* New lesions: None\n* Bone marrow: Residual uptake higher than normal, reduced from baseline\n\nPartial response via CT scan:\n\n* Lymph nodes/extralymphatic: 50% decrease in sum of diameters of \\<= 6 target measurable nodes/extranodal sites\n* Nonmeasured lesion: None/normal\n* Organ enlargement: Spleen length decreased \\> 50%\n* New lesions: No'}, {'measure': 'Overall Response Rate (ORR) Per Investigator in Cohort 5', 'timeFrame': 'From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)', 'description': 'Overall response rate (ORR) determined by Investigator assessment after JCAR017 infusion. The ORR is the percent of participants with best overall response (BOR) of either complete response (CR), complete response unconfirmed (Cru) or partial response (PR).\n\nComplete response (CR):\n\n* Brain imaging: No contrast enhancement\n* Corticosteroid dose: None\n* Eye examination: Normal\n* Cerebrospinal fluid cytology: Negative\n\nComplete response unconfirmed (CRu):\n\n* Brain imaging: No contrast enhancement, Minimal abnormality\n* Corticosteroid dose: Any\n* Eye examination: Normal, minor RPE abnormality\n* Cerebrospinal fluid cytology: Negative\n\nPartial response (PR):\n\n* Brain imaging: 50% decrease in enhancing tumor, no contrast enhancement.\n* Corticosteroid dose: Irrelevant\n* Eye examination: Minor RPE abnormality, decrease in vitreous cells or retinal infiltrate.\n* Cerebrospinal fluid cytology: Negative, persistent or suspicious'}, {'measure': 'Number of Participants With Adverse Events in Cohort 7', 'timeFrame': 'From leukapheresis to end of study (up to approximately 63 months)', 'description': "An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death."}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs) in Cohort 7', 'timeFrame': 'From leukapheresis to end of study (up to approximately 63 months)', 'description': "A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that:\n\n* Results in death;\n* Is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE);\n* Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay).\n* Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions);\n* Is a congenital anomaly/birth defect;\n* Constitutes an important medical event. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death."}, {'measure': 'Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7', 'timeFrame': 'At Baseline and Day 29 after JCAR017 infusion', 'description': 'JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death).'}, {'measure': 'Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7', 'timeFrame': 'At Baseline and Day 29 after JCAR017 infusion', 'description': 'JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5', 'timeFrame': 'From leukapheresis to end of study (up to approximately 63 months)', 'description': "An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death."}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5', 'timeFrame': 'From leukapheresis to end of study (up to approximately 63 months)', 'description': "A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that:\n\n* Results in death;\n* Is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE);\n* Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay).\n* Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions);\n* Is a congenital anomaly/birth defect;\n* Constitutes an important medical event. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death."}, {'measure': 'Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5', 'timeFrame': 'At Baseline and Day 29 after JCAR017 infusion', 'description': 'JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 = Mild, Grade 2 =Moderate, Grade 3 =Severe, Grade 4 =Life-threatening, Grade 5 =Death.'}, {'measure': 'Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5', 'timeFrame': 'At Baseline and Day 29 after JCAR017 infusion', 'description': 'JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 = Mild, Grade 2 =Moderate, Grade 3 =Severe, Grade 4 =Life-threatening, Grade 5 =Death.'}, {'measure': 'Overall Response Rate (ORR) in Cohort 7', 'timeFrame': 'From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)', 'description': 'ORR by Independent Review Committee. ORR is the percent of participants with best overall response of complete response (CR) or partial response (PR).\n\nComplete response via PET-CT:\n\n* Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease\n\nComplete response via CT scan:\n\n* Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter.\n* Nonmeasured lesion: None\n* New lesions: No\n* Bone marrow: Normal\n\nPartial response via PET-CT:\n\n* Lymph nodes/extralymphatic: Score 4, 5b, reduced uptake from baseline\n* New lesions: None\n* Bone marrow: Residual uptake higher than normal, reduced from baseline\n\nPartial response via CT scan:\n\n* Lymph nodes/extralymphatic: 50% decrease in sum of diameters of \\<= 6 target measurable nodes/extranodal sites\n* Nonmeasured lesion: None/normal\n* Organ enlargement: Spleen length decreased \\> 50%\n* New lesions: No'}, {'measure': 'Complete Response Rate (CRR)', 'timeFrame': 'From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)', 'description': 'Complete response rate is defined as percentage of participants achieving a best overall response of complete response.\n\nComplete response via PET-CT:\n\n* Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale\n* New lesions: No\n* Bone marrow: No FDG-avid disease\n\nComplete response via CT scan:\n\n* Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter.\n* Nonmeasured lesion: None\n* New lesions: No\n* Bone marrow: Normal\n\nComplete response (CR) (Cohort 5):\n\n* Brain imaging: No contrast enhancement\n* Corticosteroid dose: None\n* Eye examination: Normal\n* Cerebrospinal fluid cytology: Negative\n\nComplete response unconfirmed (CRu) (Cohort 5):\n\n* Brain imaging: No contrast enhancement, Minimal abnormality\n* Corticosteroid dose: Any\n* Eye examination: Normal, minor RPE abnormality\n* Cerebrospinal fluid cytology: Negative'}, {'measure': 'Event Free Survival (EFS)', 'timeFrame': 'From JCAR017 infusion to death due to any reason, progressive disease, or starting a new anticancer therapy (up to approximately 63 months).', 'description': 'Event-free survival is from JCAR017 infusion to death from any cause, progressive disease, or starting a new anticancer therapy. If a participant did not have an EFS event prior to data cutoff, EFS was censored at last disease assessment.\n\nProgressive disease (PD):\n\n* Target nodes/nodal masses: PPD progression.\n* Extranodal lesion: LDi \\> 1.5 cm and increase by ≥ 50% from PPD nadir.\n* Splenomegaly: \\> 50% of prior increase from baseline or by at least 2 cm from baseline.\n* Nonmeasured lesions: New or clear progression.\n* New lesions: Regrowth of previously resolved lesions.\n* Bone marrow: New or recurrent\n\nProgressive Disease (Cohort 5):\n\n* Brain imaging: \\> 25% increase in enhancing lesion from baseline or best response.\n* Eye Exam: Increased vitreous cell counts or progressive retinal or optic nerve infiltration.\n* New lesion or site of disease'}, {'measure': 'Progression Free Survival (PFS) Using European Medicines Agency (EMA) Criteria', 'timeFrame': 'From JCAR017 infusion to progressive disease or death due to any reason, whichever occurred first (up to approximately 63 months)', 'description': 'Progression-free survival is defined as the interval from the date of JCAR017 infusion to progressive disease or death due to any cause, whichever occurred first. Per European Medicines Agency (EMA) criteria, participants who did not experience progressive disease and who did not die before the data cutoff date were censored at the time of the last visit with adequate response assessment when the participants were known not to have progressed.\n\nEstimated using Kaplan-Meier product-limit estimates.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From the date of JCAR017 infusion to the date of death due to any reason (up to approximately 63 months).', 'description': 'Overall survival is defined as the interval from the date of JCAR017 infusion to the date of death due to any reason. Data from surviving participants was censored at the last time that the participant was known to be alive.\n\nEstimated using Kaplan-Meier product-limit estimates.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'From JCAR017 infusion until disease progression, death due to any reason, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)', 'description': 'DOR is from first response (complete response (CR), CR unconfirmed (CRu) or partial response (PR)) to progression (PD) or death. Those without PD or death were censored at the last assessment.\n\nCR via PET-CT: Lymph/extralymph: Score 1/2/3a w/w-out resid mass, no new lesions, No FDG-avid disease in bone marrow (BM) CR via CT scan: Lymph/extralymph: Target/nodal ≤ 1.5 cm, no new lesions, normal BM CR Cohort 5: No contrast enhance, no corticosteroid, normal eye exam, neg CSF cytology CRu Cohort 5: No contrast enhance, min abnorm, normal eye exam, neg CSF cytology PR via PET-CT: Lymph/extralymph: Score 4/5b, red uptake, no new lesions, resid uptake incr, reduced in BM PR via CT scan: Lymph/extralymph: 50% decr in sum of diam ≤ 6 target/extranodal, no new/nonmeasured lesions, Organ enlarge: Spleen decr \\> 50% PR Cohort 5: 50% decr in enhancing tumor, no contrast enhance, Eye exam: Minor abnorm, decr in vitreous cells/retinal infiltrate, negative, persist or suspic CSF cytology.'}, {'measure': 'Maximum Concentration (Cmax) of JCAR017 by qPCR', 'timeFrame': 'At baseline and up until 24 months post JCAR017 infusion', 'description': 'Cmax is the maximum or peak concentration of drug reached in the plasma following a dose of the drug.\n\nQuantitative polymerase chain reaction (qPCR) was used to determine Cmax by detecting the JCAR017 transgene.\n\nBaseline is defined as the last available recorded value on or prior to the date of JCAR017 infusion.'}, {'measure': 'Time to Peak Concentration (Tmax) of JCAR017 by qPCR', 'timeFrame': 'At baseline and up until 24 months post JCAR017 infusion', 'description': 'Time to maximum concentration (Tmax) is the time it takes for a drug to reach the maximum concentration (Cmax) after administration.\n\nQuantitative polymerase chain reaction (qPCR) was used to determine Tmax by detecting the JCAR017 transgene.\n\nBaseline is defined as the last available recorded value on or prior to the date of JCAR017 infusion.'}, {'measure': 'Total Exposure to JCAR017 as Measured by Area Under the Curve (AUC) of JCAR017 by qPCR', 'timeFrame': 'At baseline and up until 24 months post JCAR017 infusion', 'description': 'Area Under the Curve (AUC) represents the total exposure of participants to study drug.\n\nQuantitative polymerase chain reaction (qPCR) was used to determine AUC by detecting the JCAR017 transgene.\n\nBaseline is defined as the last available recorded value on or prior to the date of JCAR017 infusion.'}, {'measure': 'Percent of Participants With Presence of JCAR017 Transgene in Peripheral Blood by qPCR', 'timeFrame': 'At Day 29 and Months 2, 3, 6, 9, 12, 18, and 24 post JCAR017 infusion.', 'description': 'Persistence is defined as a transgene count greater than or equal to the lower limit of detection (LLOD) of 5 copies per reaction. Data obtained after the start of a new anti-cancer therapy were excluded. qPCR = Quantitative polymerase chain reaction.'}, {'measure': 'Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores', 'timeFrame': 'At baseline and Day 1, 29, 60, 90, 180, 270, 365, 545, and 730 post JCAR017 infusion.', 'description': 'The EORTC QLQ-C30 consists of five functional scales (physical, role, emotional, cognitive, social), three symptom scales (fatigue, nausea/vomiting, pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). The questionnaire is scored on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much. The raw score is the average of the items contributing to the scale. The final scores are calculated via linear transformation of raw scores and range from 0 to 100. For functional scales higher scores indicate better QoL. For symptom scales and single items lower scores indicate fewer symptoms, i.e. better QoL. Baseline the last available recorded scores on or prior to the date of JCAR017 infusion. Only global health, fatigue, physical and cognitive functioning subscales were assessed.'}, {'measure': 'Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma "Additional Concerns" Subscale (FACT-LymS) Scores', 'timeFrame': 'At baseline and Day 1, 29, 60, 90, 180, 270, 365, 545, and 730 post JCAR017 infusion.', 'description': 'The Functional Assessment of Cancer Treatment-Lymphoma "Additional concerns" subscale (FACT-LymS) consists of the FACT-General scale and a 15-item lymphoma-specific additional concerns subscale (LYM). This scale addresses symptoms and functional limitations that are important to lymphoma patients. Only the LYM subscale was administered in this study. 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. Lower scores indicate better health outcomes. Baseline the last available recorded scores on or prior to the date of JCAR017 infusion.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-Hodgkin lymphoma', 'Aggressive B-cell non-Hodgkin lymphoma', 'Diffuse large B-cell lymphoma', 'Relapse / refractory lymphoma', 'Transplant not eligible', 'High-grade B-cell lymphoma', 'Primary central nervous system lymphoma', 'Transformed follicular lymphoma', 'Follicular lymphoma Grade 3B', 'JCAR017', 'Liso-Cel'], 'conditions': ['Lymphoma, Non-Hodgkin']}, 'referencesModule': {'references': [{'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.'}], '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 purpose of this study is to evaluate the efficacy and safety of JCAR017 in participants with aggressive B-cell non-Hodgkin lymphoma (B-NHL)', 'detailedDescription': 'This is a study to determine the efficacy and safety of JCAR017 in adult participants with aggressive B-cell NHL. The study will enroll participants in Europe and Japan with diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS; de novo or transformed follicular lymphoma \\[tFL\\]), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (HGBL), follicular lymphoma Grade 3B (FL3B), and primary central nervous system lymphoma (PCNSL). Participants with secondary central nervous system (CNS) involvement are allowed.\n\nOnce enrolled, participants will undergo leukapheresis to enable JCAR017 cell product generation. Upon successful JCAR017 cell product generation, participants will receive lymphodepleting chemotherapy followed by infusion of JCAR017. JCAR017 will be administered by intravenous infusion. Participants will be followed for approximately 2 years after their JCAR017 infusion for safety, disease status, survival and health-related quality of life.\n\nDelayed adverse events following exposure to gene modified T cells will be assessed and long-term persistence of these modified T cells will continue to be monitored under a separate long-term follow-up protocol for up to 15 years after JCAR017 infusion as per competent authority guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological confirmation of diagnosis at last relapse\n* Adequate organ function\n* Adequate vascular access for leukapheresis procedure\n\nExclusion Criteria:\n\n* Prior history of malignancies, other than aggressive relapsed/refractory Non-Hodgkin Lymphoma, unless the participant has been in remission for ≥ 2 years with the exception of non-invasive malignancies\n* Received previous CD19-targeted therapy\n* Progressive vascular tumor invasion, thrombosis, or embolism\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT03484702', 'acronym': 'TRANSCENDWORLD', 'briefTitle': 'Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'A Phase 2, Single-arm, Multi-center Trial to Determine the Efficacy and Safety of JCAR017 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma or With Other Aggressive B-Cell Malignancies', 'orgStudyIdInfo': {'id': 'JCAR017-BCM-001'}, 'secondaryIdInfos': [{'id': 'U1111-1209-4055', 'type': 'OTHER_GRANT', 'domain': 'WHO'}, {'id': '2017-000106-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Administration of JCAR017', 'interventionNames': ['Drug: JCAR017']}], 'interventions': [{'name': 'JCAR017', 'type': 'DRUG', 'otherNames': ['Lisocabtagene Maraleucel (liso-cel)'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Administration of JCAR017']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Local Institution - 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