Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2026-01-04 @ 2:13 PM
Study NCT ID:
NCT02187861
Status:
COMPLETED
Last Update Posted:
2019-06-05
First Post:
2014-07-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Evaluating the Safety and Efficacy of Venetoclax (GDC-0199) Plus Bendamustine + Rituximab (BR) in Comparison With BR or Venetoclax Plus Rituximab in Participants With Relapsed and Refractory Follicular Non-Hodgkin's Lymphoma (fNHL)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C579720', 'term': 'venetoclax'}, {'id': 'D000069461', 'term': 'Bendamustine Hydrochloride'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to approximately 2.5 years', 'description': 'Safety-evaluable population included participants who received at least one dose of any study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.', 'otherNumAtRisk': 52, 'otherNumAffected': 49, 'seriousNumAtRisk': 52, 'seriousNumAffected': 16}, {'id': 'EG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.', 'otherNumAtRisk': 49, 'otherNumAffected': 49, 'seriousNumAtRisk': 49, 'seriousNumAffected': 26}, {'id': 'EG003', 'title': 'Chemotherapy-Containing Cohort: Arm C (BR)', 'description': 'Participants received rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.', 'otherNumAtRisk': 50, 'otherNumAffected': 48, 'seriousNumAtRisk': 50, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Aspergillus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Mycobacterium kansasii infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, 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'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Renal stone removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'ACUTE CORONARY SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'LEFT VENTRICULAR FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'HERPES SIMPLEX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'LUNG ADENOCARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'METASTATIC MALIGNANT MELANOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Complete Metabolic Response (CMR) According to Independent Review Committee (IRC) as Per Lugano Classification, Using Positron Emission Tomography (PET) Scan at Primary Response Assessment (PRA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG003', 'title': 'Chemotherapy-Containing Cohort: Arm C (BR)', 'description': 'Participants received rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '21.20', 'upperLimit': '86.30'}, {'value': '11.5', 'groupId': 'OG001', 'lowerLimit': '4.35', 'upperLimit': '23.44'}, {'value': '74.5', 'groupId': 'OG002', 'lowerLimit': '60.37', 'upperLimit': '85.67'}, {'value': '70.6', 'groupId': 'OG003', 'lowerLimit': '56.17', 'upperLimit': '82.51'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.92', 'ciLowerLimit': '-13.38', 'ciUpperLimit': '21.23', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '6-8 weeks after Cycle 6 Day 1 (PRA) (Cycle length = 28 days)', 'description': 'CMR: a score 1 (no uptake above background), 2 (uptake less than or equal to \\[\\<=\\] mediastinum), or 3 (uptake less than \\[\\<\\] mediastinum but \\<=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites with no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at PRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG003', 'title': 'Chemotherapy-Containing Cohort: Arm C (BR)', 'description': 'Participants received rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '21.20', 'upperLimit': '86.30'}, {'value': '15.4', 'groupId': 'OG001', 'lowerLimit': '6.88', 'upperLimit': '28.08'}, {'value': '70.6', 'groupId': 'OG002', 'lowerLimit': '56.17', 'upperLimit': '82.51'}, {'value': '68.6', 'groupId': 'OG003', 'lowerLimit': '54.11', 'upperLimit': '80.89'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.96', 'ciLowerLimit': '-15.89', 'ciUpperLimit': '19.81', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '4-10 weeks after Cycle 6 Day 1 (Cycle length = 28 days)', 'description': 'CMR: a score 1 (no uptake above background), 2 (uptake \\<=mediastinum), or 3 (\\<mediastinum but \\<=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With CMR According to IRC as Per Lugano Classification, Using PET Scan at Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG003', 'title': 'Chemotherapy-Containing Cohort: Arm C (BR)', 'description': 'Participants received rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '21.20', 'upperLimit': '86.30'}, {'value': '21.2', 'groupId': 'OG001', 'lowerLimit': '11.06', 'upperLimit': '34.70'}, {'value': '41.2', 'groupId': 'OG002', 'lowerLimit': '27.58', 'upperLimit': '55.83'}, {'value': '39.2', 'groupId': 'OG003', 'lowerLimit': '25.84', 'upperLimit': '53.89'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.96', 'ciLowerLimit': '-17.07', 'ciUpperLimit': '20.99', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)', 'description': 'CMR: a score 1 (no uptake above background), 2 (uptake \\<=mediastinum), or 3 (uptake \\<mediastinum but \\<=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG003', 'title': 'Chemotherapy-Containing Cohort: Arm C (BR)', 'description': 'Participants received rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '21.20', 'upperLimit': '86.30'}, {'value': '17.3', 'groupId': 'OG001', 'lowerLimit': '8.23', 'upperLimit': '30.33'}, {'value': '39.2', 'groupId': 'OG002', 'lowerLimit': '25.84', 'upperLimit': '53.89'}, {'value': '47.1', 'groupId': 'OG003', 'lowerLimit': '32.93', 'upperLimit': '61.54'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.84', 'ciLowerLimit': '-27.01', 'ciUpperLimit': '11.32', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)', 'description': 'CMR: a score 1 (no uptake above background), 2 (uptake \\<=mediastinum), or 3 (\\<mediastinum but \\<=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Response (CR) According to IRC as Per Lugano Classification, Using Computed Tomography (CT) Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG003', 'title': 'Chemotherapy-Containing Cohort: Arm C (BR)', 'description': 'Participants received rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'classes': [{'title': '6-8 weeks after Cycle 6 Day 1', 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000', 'lowerLimit': '13.70', 'upperLimit': '78.80'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '1.18', 'upperLimit': '15.66'}, {'value': '39.2', 'groupId': 'OG002', 'lowerLimit': '25.84', 'upperLimit': '53.89'}, {'value': '25.5', 'groupId': 'OG003', 'lowerLimit': '14.33', 'upperLimit': '39.63'}]}]}, {'title': 'Year 1', 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '21.20', 'upperLimit': '86.30'}, {'value': '13.2', 'groupId': 'OG001', 'lowerLimit': '5.48', 'upperLimit': '25.34'}, {'value': '27.5', 'groupId': 'OG002', 'lowerLimit': '15.89', 'upperLimit': '41.74'}, {'value': '23.5', 'groupId': 'OG003', 'lowerLimit': '12.79', 'upperLimit': '37.49'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.73', 'ciLowerLimit': '-4.24', 'ciUpperLimit': '31.69', 'groupDescription': 'At 6-8 weeks after Cycle 6 Day 1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.92', 'ciLowerLimit': '-12.98', 'ciUpperLimit': '20.82', 'groupDescription': 'At Year 1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)', 'description': 'CR: defined as reduction of longest transverse diameter of lesion (LDi) of target nodes/nodal masses to \\<=1.5 centimeters (cm), and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With CR According to Investigator as Per Lugano Classification, Using CT Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG003', 'title': 'Chemotherapy-Containing Cohort: Arm C (BR)', 'description': 'Participants received rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'classes': [{'title': '4-10 weeks after Cycle 6 Day 1', 'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000', 'lowerLimit': '2.81', 'upperLimit': '60.01'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '1.18', 'upperLimit': '15.66'}, {'value': '15.7', 'groupId': 'OG002', 'lowerLimit': '7.02', 'upperLimit': '28.59'}, {'value': '31.4', 'groupId': 'OG003', 'lowerLimit': '19.11', 'upperLimit': '45.89'}]}]}, {'title': 'Year 1', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '7.49', 'upperLimit': '70.07'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '1.18', 'upperLimit': '15.66'}, {'value': '13.7', 'groupId': 'OG002', 'lowerLimit': '5.70', 'upperLimit': '26.26'}, {'value': '21.6', 'groupId': 'OG003', 'lowerLimit': '11.29', 'upperLimit': '35.32'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.69', 'ciLowerLimit': '-31.87', 'ciUpperLimit': '0.49', 'groupDescription': 'At 4-10 weeks after Cycle 6 Day 1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.84', 'ciLowerLimit': '-22.56', 'ciUpperLimit': '6.87', 'groupDescription': 'At Year 1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)', 'description': 'CR: defined as reduction of LDi of target nodes/nodal masses to \\<=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response (OR) According to IRC as Per Lugano Classification, Using PET Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG003', 'title': 'Chemotherapy-Containing Cohort: Arm C (BR)', 'description': 'Participants received rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'classes': [{'title': '6-8 weeks after Cycle 6 Day 1', 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '21.20', 'upperLimit': '86.30'}, {'value': '21.2', 'groupId': 'OG001', 'lowerLimit': '11.06', 'upperLimit': '34.70'}, {'value': '76.5', 'groupId': 'OG002', 'lowerLimit': '62.51', 'upperLimit': '87.21'}, {'value': '74.5', 'groupId': 'OG003', 'lowerLimit': '60.37', 'upperLimit': '85.67'}]}]}, {'title': 'Year 1', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '29.93', 'upperLimit': '92.51'}, {'value': '32.7', 'groupId': 'OG001', 'lowerLimit': '20.33', 'upperLimit': '47.11'}, {'value': '45.1', 'groupId': 'OG002', 'lowerLimit': '31.13', 'upperLimit': '59.66'}, {'value': '51.0', 'groupId': 'OG003', 'lowerLimit': '36.60', 'upperLimit': '65.25'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)', 'description': 'OR was defined as CMR or Partial Metabolic Response (PMR). CMR: a score 1 (no uptake above background), 2 (uptake \\<=mediastinum), or 3 (\\<mediastinum but \\<=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately greater than \\[\\>\\] liver) or 5 (uptake markedly \\>liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG003', 'title': 'Chemotherapy-Containing Cohort: Arm C (BR)', 'description': 'Participants received rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'classes': [{'title': '4-10 weeks after Cycle 6 Day 1', 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '21.20', 'upperLimit': '86.30'}, {'value': '28.8', 'groupId': 'OG001', 'lowerLimit': '17.13', 'upperLimit': '43.08'}, {'value': '76.5', 'groupId': 'OG002', 'lowerLimit': '62.51', 'upperLimit': '87.21'}, {'value': '76.5', 'groupId': 'OG003', 'lowerLimit': '62.51', 'upperLimit': '87.21'}]}]}, {'title': 'Year 1', 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '21.20', 'upperLimit': '86.30'}, {'value': '21.2', 'groupId': 'OG001', 'lowerLimit': '11.06', 'upperLimit': '34.70'}, {'value': '39.2', 'groupId': 'OG002', 'lowerLimit': '25.84', 'upperLimit': '53.89'}, {'value': '49.0', 'groupId': 'OG003', 'lowerLimit': '34.75', 'upperLimit': '63.40'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)', 'description': 'OR was defined as CMR or PMR. CMR: a score 1 (no uptake above background), 2 (uptake \\<=mediastinum), or 3 (\\<mediastinum but \\<=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately \\>liver) or 5 (uptake markedly \\>liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With OR According to IRC as Per Lugano Classification, Using CT Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG003', 'title': 'Chemotherapy-Containing Cohort: Arm C (BR)', 'description': 'Participants received rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'classes': [{'title': '6-8 weeks after Cycle 6 Day 1', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '29.93', 'upperLimit': '92.51'}, {'value': '30.2', 'groupId': 'OG001', 'lowerLimit': '18.34', 'upperLimit': '44.34'}, {'value': '80.4', 'groupId': 'OG002', 'lowerLimit': '66.88', 'upperLimit': '90.18'}, {'value': '84.3', 'groupId': 'OG003', 'lowerLimit': '71.41', 'upperLimit': '92.98'}]}]}, {'title': 'Year 1', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '29.93', 'upperLimit': '92.51'}, {'value': '22.6', 'groupId': 'OG001', 'lowerLimit': '12.28', 'upperLimit': '36.21'}, {'value': '41.2', 'groupId': 'OG002', 'lowerLimit': '27.58', 'upperLimit': '55.83'}, {'value': '60.8', 'groupId': 'OG003', 'lowerLimit': '46.11', 'upperLimit': '74.16'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)', 'description': 'OR was defined as CR or Partial Response (PR). CR: reduction of LDi of target nodes/nodal masses to \\<=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: greater than or equal to (\\>=) 50 percent (%) decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least \\>50% beyond normal; and no new lesions. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using CT Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG003', 'title': 'Chemotherapy-Containing Cohort: Arm C (BR)', 'description': 'Participants received rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'classes': [{'title': '4-10 weeks after Cycle 6 Day 1', 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '21.20', 'upperLimit': '86.30'}, {'value': '32.1', 'groupId': 'OG001', 'lowerLimit': '19.92', 'upperLimit': '46.32'}, {'value': '74.5', 'groupId': 'OG002', 'lowerLimit': '60.37', 'upperLimit': '85.67'}, {'value': '78.4', 'groupId': 'OG003', 'lowerLimit': '64.68', 'upperLimit': '88.71'}]}]}, {'title': 'Year 1', 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '21.20', 'upperLimit': '86.30'}, {'value': '28.3', 'groupId': 'OG001', 'lowerLimit': '16.79', 'upperLimit': '42.35'}, {'value': '47.1', 'groupId': 'OG002', 'lowerLimit': '32.93', 'upperLimit': '61.54'}, {'value': '49.0', 'groupId': 'OG003', 'lowerLimit': '34.75', 'upperLimit': '63.40'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)', 'description': 'OR was defined as CR or PR. CR: reduction of LDi of target nodes/nodal masses to \\<=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: \\>=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least \\>50% beyond normal; and no new lesions. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET or CT Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG003', 'title': 'Chemotherapy-Containing Cohort: Arm C (BR)', 'description': 'Participants received rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '29.93', 'upperLimit': '92.51'}, {'value': '36.5', 'groupId': 'OG001', 'lowerLimit': '23.62', 'upperLimit': '51.04'}, {'value': '80.4', 'groupId': 'OG002', 'lowerLimit': '66.88', 'upperLimit': '90.18'}, {'value': '80.4', 'groupId': 'OG003', 'lowerLimit': '66.88', 'upperLimit': '90.18'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)', 'description': 'OR was defined as CMR/CR or PMR/PR. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. 'Overall number of participants analyzed'=those evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) According to Investigator as Per Lugano Classification, Using PET or CT Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG003', 'title': 'Chemotherapy-Containing Cohort: Arm C (BR)', 'description': 'Participants received rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.46', 'groupId': 'OG000', 'lowerLimit': '9.46', 'upperLimit': '32.46'}, {'value': '15.79', 'groupId': 'OG001', 'lowerLimit': '10.15', 'upperLimit': '23.49'}, {'value': '24.87', 'comment': 'Upper limit of 95% CI could not be calculated due to the low number of participants with event.', 'groupId': 'OG002', 'lowerLimit': '12.45', 'upperLimit': 'NA'}, {'value': '15.64', 'comment': 'Upper limit of 95% CI could not be calculated due to the low number of participants with event.', 'groupId': 'OG003', 'lowerLimit': '12.09', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.38', 'ciUpperLimit': '1.27', 'estimateComment': 'HR was calculated using Cox regression.', 'groupDescription': 'Stratified Analysis: Strata were disease burden and DOR of prior cancer therapy.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.43', 'ciUpperLimit': '1.40', 'estimateComment': 'HR was calculated using Cox regression.', 'groupDescription': 'Unstratified Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From CMR or PMR until disease progression or death due to any cause (assessed up to approximately 2.5 years)', 'description': 'DOR was defined as time from CMR/CR or PMR/PR until progressive disease (PD) or death due to any cause. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. PD: a score 4 (uptake moderately \\>liver) or 5 (uptake markedly \\>liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing). DOR was calculated using Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. 'Overall number of participants analyzed'=those evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan) or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG003', 'title': 'Chemotherapy-Containing Cohort: Arm C (BR)', 'description': 'Participants received rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000'}, {'value': '86.5', 'groupId': 'OG001'}, {'value': '41.2', 'groupId': 'OG002'}, {'value': '52.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)', 'description': 'PD: a score 4 (uptake moderately \\>liver) or 5 (uptake markedly \\>liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG003', 'title': 'Chemotherapy-Containing Cohort: Arm C (BR)', 'description': 'Participants received rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.09', 'groupId': 'OG000', 'lowerLimit': '12.78', 'upperLimit': '35.09'}, {'value': '6.57', 'groupId': 'OG001', 'lowerLimit': '6.18', 'upperLimit': '12.25'}, {'value': '27.63', 'comment': 'Upper limit of 95% CI could not be calculated due to the low number of participants with event.', 'groupId': 'OG002', 'lowerLimit': '16.07', 'upperLimit': 'NA'}, {'value': '18.43', 'comment': 'Upper limit of 95% CI could not be calculated due to the low number of participants with event.', 'groupId': 'OG003', 'lowerLimit': '16.92', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.38', 'ciUpperLimit': '1.24', 'estimateComment': 'HR was calculated using Cox regression.', 'groupDescription': 'Stratified Analysis: Strata were disease burden and PFS of prior cancer therapy.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.43', 'ciUpperLimit': '1.36', 'estimateComment': 'HR was calculated using Cox regression.', 'groupDescription': 'Unstratified Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)', 'description': 'PFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) until the date of disease progression, or death due to any cause. PD: a score 4 (uptake moderately \\>liver) or 5 (uptake markedly \\>liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. PFS was calculated using Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan), Death, or Start of a New Anti-lymphoma Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG003', 'title': 'Chemotherapy-Containing Cohort: Arm C (BR)', 'description': 'Participants received rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000'}, {'value': '86.5', 'groupId': 'OG001'}, {'value': '41.2', 'groupId': 'OG002'}, {'value': '52.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years)', 'description': 'PD: a score 4 (uptake moderately \\>liver) or 5 (uptake markedly \\>liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Event-Free Survival (EFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG003', 'title': 'Chemotherapy-Containing Cohort: Arm C (BR)', 'description': 'Participants received rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.09', 'groupId': 'OG000', 'lowerLimit': '12.78', 'upperLimit': '35.09'}, {'value': '6.57', 'groupId': 'OG001', 'lowerLimit': '6.18', 'upperLimit': '12.25'}, {'value': '27.63', 'comment': 'Upper limit of 95% CI could not be calculated due to the low number of participants with event.', 'groupId': 'OG002', 'lowerLimit': '16.07', 'upperLimit': 'NA'}, {'value': '18.43', 'comment': 'Upper limit of 95% CI could not be calculated due to the low number of participants with event.', 'groupId': 'OG003', 'lowerLimit': '16.92', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.38', 'ciUpperLimit': '1.24', 'estimateComment': 'HR was calculated using Cox regression.', 'groupDescription': 'Stratified Analysis: Strata were disease burden and EFS of prior cancer therapy.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.43', 'ciUpperLimit': '1.36', 'estimateComment': 'HR was calculated using Cox regression.', 'groupDescription': 'Unstratified Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years)', 'description': 'EFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to the date of disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first. PD: a score 4 (uptake moderately \\>liver) or 5 (uptake markedly \\>liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. EFS was calculated using Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Died Due to Any Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG003', 'title': 'Chemotherapy-Containing Cohort: Arm C (BR)', 'description': 'Participants received rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5.8', 'groupId': 'OG001'}, {'value': '2.0', 'groupId': 'OG002'}, {'value': '3.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until death due to any cause (assessed up to approximately 2.5 years', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG003', 'title': 'Chemotherapy-Containing Cohort: Arm C (BR)', 'description': 'Participants received rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and corresponding 95% CI could not be estimated due to higher number of censored participants.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and corresponding 95% CI could not be estimated due to higher number of censored participants.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and corresponding 95% CI could not be estimated due to higher number of censored participants.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and corresponding 95% CI could not be estimated due to higher number of censored participants.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '0.04', 'ciUpperLimit': '5.37', 'estimateComment': 'HR was calculated using Cox regression.', 'groupDescription': 'Stratified Analysis: Strata were disease burden and OS of prior cancer therapy.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.51', 'ciLowerLimit': '0.05', 'ciUpperLimit': '5.63', 'estimateComment': 'HR was calculated using Cox regression.', 'groupDescription': 'Unstratified Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until death due to any cause (assessed up to approximately 2.5 years)', 'description': 'OS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to death due to any cause. For participants who are alive, OS was censored at the last contact. OS was calculated using Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Apparent Clearance (CL) of Venetoclax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'timeFrame': 'Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)', 'description': 'CL is a quantitative measure of the rate at which a drug substance is removed from the body.', 'reportingStatus': 'POSTED', 'populationDescription': 'The data could not be collected as the timepoints for pharmacokinetics collection and the daily dosing of venetoclax did not permit an assessment of CL.'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution (Vd) of Venetoclax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'timeFrame': 'Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)', 'description': 'Vd was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.', 'reportingStatus': 'POSTED', 'populationDescription': 'The data could not be collected as the timepoints for pharmacokinetics collection and the daily dosing of venetoclax did not permit an assessment of Vd.'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Plasma Concentration (Tmax) of Venetoclax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.00', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '8.08'}, {'value': '6.00', 'groupId': 'OG001', 'lowerLimit': '1.95', 'upperLimit': '8.18'}, {'value': '6.21', 'groupId': 'OG002', 'lowerLimit': '1.98', 'upperLimit': '9.22'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic-evaluable population included all enrolled participants with available pharmacokinetic data for venetoclax.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration (Cmax) of Venetoclax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '1350', 'spread': '427', 'groupId': 'OG000'}, {'value': '1220', 'spread': '478', 'groupId': 'OG001'}, {'value': '1340', 'spread': '460', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic-evaluable population'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-Time Curve From Time 0 to Last Observed Concentration (AUClast) of Venetoclax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '5310', 'spread': '1730', 'groupId': 'OG000'}, {'value': '4950', 'spread': '1950', 'groupId': 'OG001'}, {'value': '5500', 'spread': '2270', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)', 'description': 'Area under the plasma concentration versus time curve from zero to the last measured concentration (AUClast).', 'unitOfMeasure': 'hours*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic-evaluable population'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-Time Curve From Time 0 to 8 Hours Post Dose (AUC0-8h) of Venetoclax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'OG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '5240', 'spread': '1860', 'groupId': 'OG000'}, {'value': '4820', 'spread': '1980', 'groupId': 'OG001'}, {'value': '5330', 'spread': '2270', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)', 'description': 'Area under the plasma concentration versus time curve from time 0 (pre-dose) to 8 hours post dose (AUC0-8h).', 'unitOfMeasure': 'hours*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacokinetic-evaluable population. 'Overall number of participants analyzed'=those evaluable for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'FG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'FG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'FG003', 'title': 'Chemotherapy-Containing Cohort: Arm C (BR)', 'description': 'Participants received rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '51'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '49'}, {'groupId': 'FG003', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '22'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '163', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants received venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in continued until first 9 participants completed the safety observation window of 28 days. After first 28 days of safety observation (Cycle 1), participants continued to receive venetoclax 600 mg orally once daily up to 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'BG001', 'title': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants received venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle was of 28 days.'}, {'id': 'BG002', 'title': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants received venetoclax 800 mg orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'BG003', 'title': 'Chemotherapy-Containing Cohort: Arm C (BR)', 'description': 'Participants received rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.9', 'spread': '12.7', 'groupId': 'BG000'}, {'value': '61.9', 'spread': '12.0', 'groupId': 'BG001'}, {'value': '64.9', 'spread': '9.8', 'groupId': 'BG002'}, {'value': '61.0', 'spread': '11.6', 'groupId': 'BG003'}, {'value': '62.3', 'spread': '11.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) population included all enrolled participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 163}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-03', 'studyFirstSubmitDate': '2014-07-09', 'resultsFirstSubmitDate': '2017-09-15', 'studyFirstSubmitQcDate': '2014-07-09', 'lastUpdatePostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-09-15', 'studyFirstPostDateStruct': {'date': '2014-07-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Complete Metabolic Response (CMR) According to Independent Review Committee (IRC) as Per Lugano Classification, Using Positron Emission Tomography (PET) Scan at Primary Response Assessment (PRA)', 'timeFrame': '6-8 weeks after Cycle 6 Day 1 (PRA) (Cycle length = 28 days)', 'description': 'CMR: a score 1 (no uptake above background), 2 (uptake less than or equal to \\[\\<=\\] mediastinum), or 3 (uptake less than \\[\\<\\] mediastinum but \\<=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites with no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at PRA', 'timeFrame': '4-10 weeks after Cycle 6 Day 1 (Cycle length = 28 days)', 'description': 'CMR: a score 1 (no uptake above background), 2 (uptake \\<=mediastinum), or 3 (\\<mediastinum but \\<=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.'}, {'measure': 'Percentage of Participants With CMR According to IRC as Per Lugano Classification, Using PET Scan at Year 1', 'timeFrame': '48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)', 'description': 'CMR: a score 1 (no uptake above background), 2 (uptake \\<=mediastinum), or 3 (uptake \\<mediastinum but \\<=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.'}, {'measure': 'Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at Year 1', 'timeFrame': '48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)', 'description': 'CMR: a score 1 (no uptake above background), 2 (uptake \\<=mediastinum), or 3 (\\<mediastinum but \\<=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.'}, {'measure': 'Percentage of Participants With Complete Response (CR) According to IRC as Per Lugano Classification, Using Computed Tomography (CT) Scan', 'timeFrame': '6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)', 'description': 'CR: defined as reduction of longest transverse diameter of lesion (LDi) of target nodes/nodal masses to \\<=1.5 centimeters (cm), and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.'}, {'measure': 'Percentage of Participants With CR According to Investigator as Per Lugano Classification, Using CT Scan', 'timeFrame': '4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)', 'description': 'CR: defined as reduction of LDi of target nodes/nodal masses to \\<=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.'}, {'measure': 'Percentage of Participants With Objective Response (OR) According to IRC as Per Lugano Classification, Using PET Scan', 'timeFrame': '6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)', 'description': 'OR was defined as CMR or Partial Metabolic Response (PMR). CMR: a score 1 (no uptake above background), 2 (uptake \\<=mediastinum), or 3 (\\<mediastinum but \\<=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately greater than \\[\\>\\] liver) or 5 (uptake markedly \\>liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.'}, {'measure': 'Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET Scan', 'timeFrame': '4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)', 'description': 'OR was defined as CMR or PMR. CMR: a score 1 (no uptake above background), 2 (uptake \\<=mediastinum), or 3 (\\<mediastinum but \\<=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately \\>liver) or 5 (uptake markedly \\>liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.'}, {'measure': 'Percentage of Participants With OR According to IRC as Per Lugano Classification, Using CT Scan', 'timeFrame': '6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)', 'description': 'OR was defined as CR or Partial Response (PR). CR: reduction of LDi of target nodes/nodal masses to \\<=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: greater than or equal to (\\>=) 50 percent (%) decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least \\>50% beyond normal; and no new lesions. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.'}, {'measure': 'Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using CT Scan', 'timeFrame': '4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)', 'description': 'OR was defined as CR or PR. CR: reduction of LDi of target nodes/nodal masses to \\<=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: \\>=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least \\>50% beyond normal; and no new lesions. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.'}, {'measure': 'Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET or CT Scan', 'timeFrame': 'Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)', 'description': 'OR was defined as CMR/CR or PMR/PR. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing).'}, {'measure': 'Duration of Response (DOR) According to Investigator as Per Lugano Classification, Using PET or CT Scan', 'timeFrame': 'From CMR or PMR until disease progression or death due to any cause (assessed up to approximately 2.5 years)', 'description': 'DOR was defined as time from CMR/CR or PMR/PR until progressive disease (PD) or death due to any cause. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. PD: a score 4 (uptake moderately \\>liver) or 5 (uptake markedly \\>liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing). DOR was calculated using Kaplan-Meier method.'}, {'measure': 'Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan) or Death', 'timeFrame': 'Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)', 'description': 'PD: a score 4 (uptake moderately \\>liver) or 5 (uptake markedly \\>liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan.'}, {'measure': 'Progression-Free Survival (PFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan', 'timeFrame': 'Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)', 'description': 'PFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) until the date of disease progression, or death due to any cause. PD: a score 4 (uptake moderately \\>liver) or 5 (uptake markedly \\>liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. PFS was calculated using Kaplan-Meier method.'}, {'measure': 'Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan), Death, or Start of a New Anti-lymphoma Therapy', 'timeFrame': 'Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years)', 'description': 'PD: a score 4 (uptake moderately \\>liver) or 5 (uptake markedly \\>liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan.'}, {'measure': 'Event-Free Survival (EFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan', 'timeFrame': 'Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years)', 'description': 'EFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to the date of disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first. PD: a score 4 (uptake moderately \\>liver) or 5 (uptake markedly \\>liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. EFS was calculated using Kaplan-Meier method.'}, {'measure': 'Percentage of Participants Who Died Due to Any Cause', 'timeFrame': 'Baseline until death due to any cause (assessed up to approximately 2.5 years'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Baseline until death due to any cause (assessed up to approximately 2.5 years)', 'description': 'OS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to death due to any cause. For participants who are alive, OS was censored at the last contact. OS was calculated using Kaplan-Meier method.'}, {'measure': 'Apparent Clearance (CL) of Venetoclax', 'timeFrame': 'Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)', 'description': 'CL is a quantitative measure of the rate at which a drug substance is removed from the body.'}, {'measure': 'Apparent Volume of Distribution (Vd) of Venetoclax', 'timeFrame': 'Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)', 'description': 'Vd was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) of Venetoclax', 'timeFrame': 'Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Venetoclax', 'timeFrame': 'Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)'}, {'measure': 'Area Under the Plasma Concentration-Time Curve From Time 0 to Last Observed Concentration (AUClast) of Venetoclax', 'timeFrame': 'Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)', 'description': 'Area under the plasma concentration versus time curve from zero to the last measured concentration (AUClast).'}, {'measure': 'Area Under the Plasma Concentration-Time Curve From Time 0 to 8 Hours Post Dose (AUC0-8h) of Venetoclax', 'timeFrame': 'Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)', 'description': 'Area under the plasma concentration versus time curve from time 0 (pre-dose) to 8 hours post dose (AUC0-8h).'}]}, 'conditionsModule': {'conditions': ['Follicular Lymphoma']}, 'referencesModule': {'references': [{'pmid': '32785666', 'type': 'DERIVED', 'citation': 'Zinzani PL, Flinn IW, Yuen SLS, Topp MS, Rusconi C, Fleury I, Le Du K, Arthur C, Pro B, Gritti G, Crump M, Petrich A, Samineni D, Sinha A, Punnoose EA, Szafer-Glusman E, Spielewoy N, Mobasher M, Humphrey K, Kornacker M, Hiddemann W. Venetoclax-rituximab with or without bendamustine vs bendamustine-rituximab in relapsed/refractory follicular lymphoma. Blood. 2020 Dec 3;136(23):2628-2637. doi: 10.1182/blood.2020005588.'}]}, 'descriptionModule': {'briefSummary': 'This open-label, international, multicenter study will investigate the safety and efficacy of venetoclax (GDC-0199) in combination with bendamustine plus rituximab (venetoclax + BR) compared with BR alone in participants with relapsed and refractory fNHL, comparing two chemotherapy-containing regimens (Chemotherapy-Containing Cohort). In addition, an exploratory analysis of the safety and efficacy of venetoclax in combination with rituximab (venetoclax + rituximab), a chemotherapy-free regimen, will be performed (Chemotherapy-Free Cohort). Assignment to the Chemotherapy-Containing or Chemotherapy-Free Cohort will be decided at the discretion of the Investigator, unless one of the cohorts is not open to enrollment; in which case, participants may be enrolled only to the open cohort. The first 6 participants enrolled in the Chemotherapy-Containing Cohort (or more if required) will comprise the Safety Run-In group for Treatment Arm B, dosing venetoclax at 600 milligrams (mg) in combination with BR. Once a dose has been chosen from the Safety Run-In Period, randomization to the two treatment arms of the Chemotherapy-Containing Cohort (Arms B and C) will begin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must have histologically confirmed follicular lymphoma (FL) of Grade 1, 2, or 3a\n* Participants must have received at least one prior therapy for FL\n* For participants potentially receiving chemotherapy: if the participant has received prior bendamustine, response duration must have been greater than (\\>) 1 year\n* At least one bi-dimensionally measurable lesion on imaging scan defined as \\>1.5 centimeters (cm) in its longest dimension\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2\n* Adequate hematologic function\n* For female participants of childbearing potential and male participants with female partners of childbearing potential, agreement to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception throughout the course of study treatment and for at least 30 days after the last dose of venetoclax and 12 months after the last dose of rituximab, whichever is longer\n* Confirmed availability of archival or freshly biopsied tumor tissue meeting protocol-defined specifications prior to study enrollment\n\nExclusion Criteria:\n\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products\n* Contraindication to potential treatment agents\n* Ongoing corticosteroid use \\>30 milligrams per day (mg/day) of prednisone or equivalent. Participants receiving corticosteroid treatment with less than equal to (\\</=) 30 mg/day of prednisone or equivalent must be documented to be on a stable dose of at least 4 weeks duration prior to randomization (Cycle 1 Day 1)\n* Primary central nervous system (CNS) lymphoma\n* Vaccination with live vaccines within 28 days prior to treatment\n* Chemotherapy or other investigational therapy within five half-lives of a biologic agent with a minimum of 28 days prior to the start of Cycle 1\n* History of other malignancy that could affect compliance with the protocol or interpretation of results\n* Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or that could increase risk to the participant\n* Significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, congestive heart failure, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1 Day 1\n* Requires the use of warfarin\n* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis\n* Presence of positive test results for hepatitis B surface antigen or hepatitis C virus (HCV) antibody\n* Participants who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation\n* Participants with occult or prior hepatitis B virus (HBV) infection may be included if HBV deoxyribonucleic acid (DNA) is undetectable at screening. These participants must be willing to undergo monthly HBV DNA test until at least 12 months after the last treatment cycle\n* Known infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus 1 (HTLV-1)\n* Pregnant or lactating\n* Recent major surgery (within 6 weeks before the start of Cycle 1 Day 1), other than for diagnosis'}, 'identificationModule': {'nctId': 'NCT02187861', 'briefTitle': "A Study Evaluating the Safety and Efficacy of Venetoclax (GDC-0199) Plus Bendamustine + Rituximab (BR) in Comparison With BR or Venetoclax Plus Rituximab in Participants With Relapsed and Refractory Follicular Non-Hodgkin's Lymphoma (fNHL)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': "A Phase II, Open-Label Study Evaluating the Safety and Efficacy of GDC-0199 (ABT-199) Plus Bendamustine Plus Rituximab (BR) in Comparison With BR Alone or GDC-0199 Plus Rituximab (R) in Patients With Relapsed and Refractory Follicular Non-Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'BO29337'}, 'secondaryIdInfos': [{'id': '2014-000576-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'description': 'Participants will receive venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in will continue until first 9 participants complete the safety observation window of 28 days. Participants will continue receiving the same treatment as decided for Arm B.', 'interventionNames': ['Drug: Venetoclax', 'Drug: Bendamustine', 'Drug: Rituximab']}, {'type': 'EXPERIMENTAL', 'label': 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)', 'description': 'Participants will receive venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle will be of 28 days.', 'interventionNames': ['Drug: Venetoclax', 'Drug: Rituximab']}, {'type': 'EXPERIMENTAL', 'label': 'Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'description': 'Participants will receive venetoclax at doses decided from safety run-in orally once daily continuously for 1 year along with rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.', 'interventionNames': ['Drug: Venetoclax', 'Drug: Bendamustine', 'Drug: Rituximab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chemotherapy-Containing Cohort: Arm C (BR)', 'description': 'Participants will receive rituximab 375 mg/m\\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.', 'interventionNames': ['Drug: Bendamustine', 'Drug: Rituximab']}], 'interventions': [{'name': 'Venetoclax', 'type': 'DRUG', 'otherNames': ['GDC-0199', 'ABT-199'], 'description': 'Venetoclax will be administered as per the schedule specified under arm description.', 'armGroupLabels': ['Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)']}, {'name': 'Bendamustine', 'type': 'DRUG', 'otherNames': ['Levact'], 'description': 'Bendamustine will be administered as per the schedule specified under arm description.', 'armGroupLabels': ['Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'Chemotherapy-Containing Cohort: Arm C (BR)', 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)']}, {'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['MabThera', 'Rituxan'], 'description': 'Rituximab will be administered as per the schedule specified under arm description.', 'armGroupLabels': ['Chemotherapy-Containing Cohort: Arm B (Venetoclax + BR)', 'Chemotherapy-Containing Cohort: Arm C (BR)', 'Chemotherapy-Containing Cohort:Safety Run-In (Venetoclax + BR)', 'Chemotherapy-Free Cohort: Arm A (Venetoclax + Rituximab)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Southern Cancer Center, PC', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA School of Medicine; Hematology/Oncology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '30106', 'city': 'Austell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Nothwest Georgia Oncology Centers P.C', 'geoPoint': {'lat': 33.81261, 'lon': -84.63438}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612-7302', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago College of Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60426', 'city': 'Harvey', 'state': 'Illinois', 'country': 'United States', 'facility': 'Primary Healthcare Associates SC - Harvey', 'geoPoint': {'lat': 41.61003, 'lon': -87.64671}}, {'zip': '66205', 'city': 'Westwood', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas; Medical Center & Medical pavilion', 'geoPoint': {'lat': 39.04056, 'lon': -94.6169}}, {'zip': '21231-1000', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comp Cancer Ctr', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'James P. 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