Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-31 @ 1:31 PM
Study NCT ID:
NCT04285567
Status:
COMPLETED
Last Update Posted:
2025-10-08
First Post:
2020-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C543332', 'term': 'obinutuzumab'}, {'id': 'C579720', 'term': 'venetoclax'}, {'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D000069461', 'term': 'Bendamustine Hydrochloride'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'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'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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': 'Up to approximately 44.4 months', 'description': 'AEs: Safety Population included all participants who received at least one dose of any study medication.\n\nAll-cause mortality: FAS included all randomized participants, analyzed according to the treatment to which they were randomized.\n\nThis study is ongoing and data collected up to the primary completion date are reported here. AE data will be updated one year after study completion date.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A: VEN+G', 'description': 'Participants received obinutuzumab, 1000 mg, as IV infusion on Days 1 (and 2), 8, and 15 of Cycle 1 and Day 1 of Cycles 2-6. Participants also received venetoclax, with a 5-week ramp-up period (20 mg \\[Cycle 1 Days 22-28\\], 50 mg \\[Cycle 2 Days 1-7\\], 100 mg \\[Cycle 2 Days 8-14\\], 200 mg \\[Cycle 2 Days 15-21\\], 400 mg \\[Cycle 2 Days 22-28\\]) administered orally, QD. After the 5-week ramp-up period, participants received venetoclax, 400 mg, orally, QD from Cycle 3 Day 1 until the end of Cycle 12. (1 cycle = 28 days).', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 80, 'otherNumAffected': 76, 'seriousNumAtRisk': 77, 'deathsNumAffected': 3, 'seriousNumAffected': 47}, {'id': 'EG001', 'title': 'Arm B: FCR/BR', 'description': 'Participants received rituximab (375 mg/m\\^2 in Cycle 1 and 500 mg/m\\^2 in Cycles 2-6), on Day 1 of each cycle, plus fludarabine 25 mg/m\\^2 and cyclophosphamide 250 mg/m\\^2 on Days 1, 2, and 3 of each cycle as IV infusion up to Cycle 6. Participants alternatively received bendamustine 90 mg/m\\^2 on Days 1 and 2 of Cycles 1-6 plus rituximab 375 mg/m\\^2 on Day 1 of Cycle 1 and 500 mg/m\\^2 on Day 1 of Cycles 2-6. (1 cycle = 28 days).', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 86, 'otherNumAffected': 80, 'seriousNumAtRisk': 85, 'deathsNumAffected': 3, 'seriousNumAffected': 42}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 21, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 106, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 81, 'numAffected': 40}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 41, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 24, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 32, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 67, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 25, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 35, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 29, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Incorrect drug administration rate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 13, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 80, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 51, 'numAffected': 34}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 12, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Tumour lysis syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 27, 'numAffected': 23}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Apical granuloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Hepatotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Beta haemolytic streptococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Bronchopulmonary aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Pneumonia fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Rhinovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Hyperphosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Hypouricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Tumour lysis syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Eccrine carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': "Hodgkin's disease lymphocyte predominance type stage unspecified", 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Skin cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Acute febrile neutrophilic dermatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Minimal Residual Disease (MRD) Response Rate Measured in Peripheral Blood (PB) Using Next Generation Sequencing (NGS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: VEN+G', 'description': 'Participants received obinutuzumab, 1000 mg, as IV infusion on Days 1 (and 2), 8, and 15 of Cycle 1 and Day 1 of Cycles 2-6. Participants also received venetoclax, with a 5-week ramp-up period (20 mg \\[Cycle 1 Days 22-28\\], 50 mg \\[Cycle 2 Days 1-7\\], 100 mg \\[Cycle 2 Days 8-14\\], 200 mg \\[Cycle 2 Days 15-21\\], 400 mg \\[Cycle 2 Days 22-28\\]) administered orally, QD. After the 5-week ramp-up period, participants received venetoclax, 400 mg, orally, QD from Cycle 3 Day 1 until the end of Cycle 12. (1 cycle = 28 days).'}, {'id': 'OG001', 'title': 'Arm B: FCR/BR', 'description': 'Participants received rituximab (375 mg/m\\^2 in Cycle 1 and 500 mg/m\\^2 in Cycles 2-6), on Day 1 of each cycle, plus fludarabine 25 mg/m\\^2 and cyclophosphamide 250 mg/m\\^2 on Days 1, 2, and 3 of each cycle as IV infusion up to Cycle 6. Participants alternatively received bendamustine 90 mg/m\\^2 on Days 1 and 2 of Cycles 1-6 plus rituximab 375 mg/m\\^2 on Day 1 of Cycle 1 and 500 mg/m\\^2 on Day 1 of Cycles 2-6. (1 cycle = 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '81.3', 'groupId': 'OG000', 'lowerLimit': '70.97', 'upperLimit': '89.11'}, {'value': '54.7', 'groupId': 'OG001', 'lowerLimit': '43.55', 'upperLimit': '65.42'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.60', 'ciLowerLimit': '12.33', 'ciUpperLimit': '40.87', 'estimateComment': '95% CI for difference in rates were constructed using Anderson-Hauck method.', 'groupDescription': 'P-value estimated using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 15', 'description': 'MRD response rate was determined as the percentage of participants with MRD-negativity measured in the PB using NGS using a cutoff of \\< 10\\^-4. MRD was considered negative if the result was \\< 1 CLL cell in 10,000 leukocytes. Percentages have been rounded off to the nearest decimal point.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, analyzed according to the treatment to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'timeFrame': 'Up to approximately 74 months', 'description': 'PFS was defined as the time from randomization to the first occurrence of disease progression (PD), or death from any cause. PD was assessed by the investigators using the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. PD was defined as any one of the following: Appearance of any new lesion such as enlarged lymph nodes (≥ 1.5 centimeters \\[cm\\]); increase by ≥ 50% in greatest diameter of any previous site (≥ 1.5 cm); increase in the spleen/liver size by ≥ 50% or de novo appearance of splenomegaly/hepatomegaly; increase in blood lymphocytes by 50% or more with at least 5x10\\^9/litres (L) B lymphocytes; transformation to a more aggressive histology; occurrence of cytopenia; posttreatment: progression of any cytopenia, documented by a decrease of hemoglobin (Hb) ≥ 2 grams per deciliter (g/dL) or 10 g/dL, or by a decrease of platelet counts ≥ 50%/100x10\\^9/L, which occurs at least 3 months after treatment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-07'}, {'type': 'SECONDARY', 'title': 'MRD Response Rate in PB of FCR/BR Compared With VEN+G at the End of Treatment Response Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: VEN+G', 'description': 'Participants received obinutuzumab, 1000 mg, as IV infusion on Days 1 (and 2), 8, and 15 of Cycle 1 and Day 1 of Cycles 2-6. Participants also received venetoclax, with a 5-week ramp-up period (20 mg \\[Cycle 1 Days 22-28\\], 50 mg \\[Cycle 2 Days 1-7\\], 100 mg \\[Cycle 2 Days 8-14\\], 200 mg \\[Cycle 2 Days 15-21\\], 400 mg \\[Cycle 2 Days 22-28\\]) administered orally, QD. After the 5-week ramp-up period, participants received venetoclax, 400 mg, orally, QD from Cycle 3 Day 1 until the end of Cycle 12. (1 cycle = 28 days).'}, {'id': 'OG001', 'title': 'Arm B: FCR/BR', 'description': 'Participants received rituximab (375 mg/m\\^2 in Cycle 1 and 500 mg/m\\^2 in Cycles 2-6), on Day 1 of each cycle, plus fludarabine 25 mg/m\\^2 and cyclophosphamide 250 mg/m\\^2 on Days 1, 2, and 3 of each cycle as IV infusion up to Cycle 6. Participants alternatively received bendamustine 90 mg/m\\^2 on Days 1 and 2 of Cycles 1-6 plus rituximab 375 mg/m\\^2 on Day 1 of Cycle 1 and 500 mg/m\\^2 on Day 1 of Cycles 2-6. (1 cycle = 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '81.3', 'groupId': 'OG000', 'lowerLimit': '70.97', 'upperLimit': '89.11'}, {'value': '60.5', 'groupId': 'OG001', 'lowerLimit': '49.34', 'upperLimit': '70.85'}]}]}], 'analyses': [{'pValue': '0.0053', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.78', 'ciLowerLimit': '6.66', 'ciUpperLimit': '34.90', 'estimateComment': '95% CI for difference in rates were constructed using Anderson-Hauck method.', 'groupDescription': 'P-value estimated using CMH test stratified by the IvRS randomization stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'VEN+G: From Cycle 1 Day 1 up to 15 months; FCR/BR: From Cycle 1 Day 1 up to 9 months (1 cycle=28 days)', 'description': 'MRD response rate was determined as the percentage of participants with MRD-negativity measured in the PB using NGS using a cutoff of \\< 10\\^-4. MRD was considered negative if the result was \\< 1 CLL cell in 10,000 leukocytes. Percentages have been rounded off to the nearest decimal point.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, analyzed according to the treatment to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'MRD Response Rate in Bone Marrow (BM) of FCR/BR Compared With VEN+G at the End of Treatment Response Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: VEN+G', 'description': 'Participants received obinutuzumab, 1000 mg, as IV infusion on Days 1 (and 2), 8, and 15 of Cycle 1 and Day 1 of Cycles 2-6. Participants also received venetoclax, with a 5-week ramp-up period (20 mg \\[Cycle 1 Days 22-28\\], 50 mg \\[Cycle 2 Days 1-7\\], 100 mg \\[Cycle 2 Days 8-14\\], 200 mg \\[Cycle 2 Days 15-21\\], 400 mg \\[Cycle 2 Days 22-28\\]) administered orally, QD. After the 5-week ramp-up period, participants received venetoclax, 400 mg, orally, QD from Cycle 3 Day 1 until the end of Cycle 12. (1 cycle = 28 days).'}, {'id': 'OG001', 'title': 'Arm B: FCR/BR', 'description': 'Participants received rituximab (375 mg/m\\^2 in Cycle 1 and 500 mg/m\\^2 in Cycles 2-6), on Day 1 of each cycle, plus fludarabine 25 mg/m\\^2 and cyclophosphamide 250 mg/m\\^2 on Days 1, 2, and 3 of each cycle as IV infusion up to Cycle 6. Participants alternatively received bendamustine 90 mg/m\\^2 on Days 1 and 2 of Cycles 1-6 plus rituximab 375 mg/m\\^2 on Day 1 of Cycle 1 and 500 mg/m\\^2 on Day 1 of Cycles 2-6. (1 cycle = 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000', 'lowerLimit': '58.72', 'upperLimit': '79.74'}, {'value': '38.4', 'groupId': 'OG001', 'lowerLimit': '28.08', 'upperLimit': '49.49'}]}]}], 'analyses': [{'pValue': '< .0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.63', 'ciLowerLimit': '16.55', 'ciUpperLimit': '46.71', 'estimateComment': '95% CI for difference in rates were constructed using Anderson-Hauck method.', 'groupDescription': 'P-value estimated using CMH test stratified by the IvRS randomization stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'VEN+G: From Cycle 1 Day 1 up to 15 months; FCR/BR: From Cycle 1 Day 1 up to 9 months (1 cycle=28 days)', 'description': 'MRD response rate=percentage of participants with MRD-negativity measured in BM using NGS (cutoff of \\<10\\^-4). MRD negativity=\\<1 CLL cell in 10,000 leukocytes. MRD in BM was assessed for participants with complete response (CR)/CR with incomplete blood count recovery (CRi) \\& partial response (PR). CR=PB lymphocytes \\<4x10\\^9 /L; Absence of significant lymphadenopathy (nodes \\<1.5 cm in longest diameter); no hepatomegaly/splenomegaly; absence of disease/constitutional symptoms; BM at least normocellular for age, ≤30% of nucleated cells being lymphocytes. CRi=fulfilling CR criteria but with persistent anemia/thrombocytopenia/neutropenia. PR= ≥50% decrease in PB lymphocyte count from pre-treatment value; ≥50% reduction in lymphadenopathy (sum of longest diameter of up to 6 largest lymph nodes by physical exam \\& 50% reduction in the sum of product of the diameter of up to 6 largest lymph nodes); ≥50% reduction of liver/spleen enlargement/normalization in size, if enlarged at baseline.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, analyzed according to the treatment to which they were randomized. Percentages have been rounded off to the nearest decimal point.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: VEN+G', 'description': 'Participants received obinutuzumab, 1000 mg, as IV infusion on Days 1 (and 2), 8, and 15 of Cycle 1 and Day 1 of Cycles 2-6. Participants also received venetoclax, with a 5-week ramp-up period (20 mg \\[Cycle 1 Days 22-28\\], 50 mg \\[Cycle 2 Days 1-7\\], 100 mg \\[Cycle 2 Days 8-14\\], 200 mg \\[Cycle 2 Days 15-21\\], 400 mg \\[Cycle 2 Days 22-28\\]) administered orally, QD. After the 5-week ramp-up period, participants received venetoclax, 400 mg, orally, QD from Cycle 3 Day 1 until the end of Cycle 12. (1 cycle = 28 days).'}, {'id': 'OG001', 'title': 'Arm B: FCR/BR', 'description': 'Participants received rituximab (375 mg/m\\^2 in Cycle 1 and 500 mg/m\\^2 in Cycles 2-6), on Day 1 of each cycle, plus fludarabine 25 mg/m\\^2 and cyclophosphamide 250 mg/m\\^2 on Days 1, 2, and 3 of each cycle as IV infusion up to Cycle 6. Participants alternatively received bendamustine 90 mg/m\\^2 on Days 1 and 2 of Cycles 1-6 plus rituximab 375 mg/m\\^2 on Day 1 of Cycle 1 and 500 mg/m\\^2 on Day 1 of Cycles 2-6. (1 cycle = 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '88.8', 'groupId': 'OG000', 'lowerLimit': '79.72', 'upperLimit': '94.72'}, {'value': '79.1', 'groupId': 'OG001', 'lowerLimit': '68.95', 'upperLimit': '87.10'}]}]}], 'analyses': [{'pValue': '0.1119', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.68', 'ciLowerLimit': '-2.05', 'ciUpperLimit': '21.41', 'estimateComment': '95% CI for difference in rates were constructed using Anderson-Hauck method.', 'groupDescription': 'P-value estimated using CMH test stratified by the IvRS randomization stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 15', 'description': 'ORR was defined as the percentage of participants with overall response (OR) of CR, CRi, and PR as determined by the investigator according to the iwCLL guidelines. CR was defined as PB lymphocytes \\<4x10\\^9 /L; absence of significant lymphadenopathy (nodes \\<1.5 cm in longest diameter \\[LD\\]); no hepatomegaly/splenomegaly; absence of disease/constitutional symptoms; BM at least normocellular for age, ≤30% of nucleated cells being lymphocytes. CRi was defined as fulfilling CR criteria but with persistent anemia/thrombocytopenia/neutropenia. PR was defined as ≥50% decrease in PB lymphocyte count from pre-treatment value; ≥50% reduction in lymphadenopathy sum of longest diameter of up to 6 largest lymph nodes by physical exam and 50% reduction in the sum of product of the diameter of up to 6 largest lymph nodes); ≥50% reduction of liver/spleen enlargement/normalization in size, if enlarged at baseline.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, analyzed according to the treatment to which they were randomized. Percentages have been rounded off to the nearest decimal point.'}, {'type': 'SECONDARY', 'title': 'CR Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: VEN+G', 'description': 'Participants received obinutuzumab, 1000 mg, as IV infusion on Days 1 (and 2), 8, and 15 of Cycle 1 and Day 1 of Cycles 2-6. Participants also received venetoclax, with a 5-week ramp-up period (20 mg \\[Cycle 1 Days 22-28\\], 50 mg \\[Cycle 2 Days 1-7\\], 100 mg \\[Cycle 2 Days 8-14\\], 200 mg \\[Cycle 2 Days 15-21\\], 400 mg \\[Cycle 2 Days 22-28\\]) administered orally, QD. After the 5-week ramp-up period, participants received venetoclax, 400 mg, orally, QD from Cycle 3 Day 1 until the end of Cycle 12. (1 cycle = 28 days).'}, {'id': 'OG001', 'title': 'Arm B: FCR/BR', 'description': 'Participants received rituximab (375 mg/m\\^2 in Cycle 1 and 500 mg/m\\^2 in Cycles 2-6), on Day 1 of each cycle, plus fludarabine 25 mg/m\\^2 and cyclophosphamide 250 mg/m\\^2 on Days 1, 2, and 3 of each cycle as IV infusion up to Cycle 6. Participants alternatively received bendamustine 90 mg/m\\^2 on Days 1 and 2 of Cycles 1-6 plus rituximab 375 mg/m\\^2 on Day 1 of Cycle 1 and 500 mg/m\\^2 on Day 1 of Cycles 2-6. (1 cycle = 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '38.60', 'upperLimit': '61.40'}, {'value': '32.6', 'groupId': 'OG001', 'lowerLimit': '22.84', 'upperLimit': '43.52'}]}]}], 'analyses': [{'pValue': '0.0154', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.44', 'ciLowerLimit': '1.96', 'ciUpperLimit': '32.93', 'estimateComment': '95% CI for difference in rates were constructed using Anderson-Hauck method.', 'groupDescription': 'P-value estimated using CMH test stratified by the IvRS randomization stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 15', 'description': 'CR rate was defined as the percentage of participants with CR or CRi. CR/CRi were defined according to the iwCLL guidelines. CR was defined as one of the following: PB lymphocytes (evaluated by blood and differential count) below 4 x 10\\^9 /L; absence of significant lymphadenopathy (nodes \\< 1.5 cm in LD or any extra nodal disease); no hepatomegaly; no splenomegaly; absence of disease or constitutional symptoms; BM at least normocellular for age, ≤30% of nucleated cells being lymphocytes. CRi was defined as participants fulfilling CR criteria but had persistent anemia, thrombocytopenia, or neutropenia. Percentages have been rounded off to the nearest decimal point.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, analyzed according to the treatment to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'MRD Response Rate in PB of Participants With a CR/CRi at the End of Treatment Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: VEN+G', 'description': 'Participants received obinutuzumab, 1000 mg, as IV infusion on Days 1 (and 2), 8, and 15 of Cycle 1 and Day 1 of Cycles 2-6. Participants also received venetoclax, with a 5-week ramp-up period (20 mg \\[Cycle 1 Days 22-28\\], 50 mg \\[Cycle 2 Days 1-7\\], 100 mg \\[Cycle 2 Days 8-14\\], 200 mg \\[Cycle 2 Days 15-21\\], 400 mg \\[Cycle 2 Days 22-28\\]) administered orally, QD. After the 5-week ramp-up period, participants received venetoclax, 400 mg, orally, QD from Cycle 3 Day 1 until the end of Cycle 12. (1 cycle = 28 days).'}, {'id': 'OG001', 'title': 'Arm B: FCR/BR', 'description': 'Participants received rituximab (375 mg/m\\^2 in Cycle 1 and 500 mg/m\\^2 in Cycles 2-6), on Day 1 of each cycle, plus fludarabine 25 mg/m\\^2 and cyclophosphamide 250 mg/m\\^2 on Days 1, 2, and 3 of each cycle as IV infusion up to Cycle 6. Participants alternatively received bendamustine 90 mg/m\\^2 on Days 1 and 2 of Cycles 1-6 plus rituximab 375 mg/m\\^2 on Day 1 of Cycle 1 and 500 mg/m\\^2 on Day 1 of Cycles 2-6. (1 cycle = 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000', 'lowerLimit': '86.84', 'upperLimit': '99.94'}, {'value': '78.6', 'groupId': 'OG001', 'lowerLimit': '59.05', 'upperLimit': '91.70'}]}]}], 'analyses': [{'pValue': '0.0054', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.93', 'ciLowerLimit': '0.91', 'ciUpperLimit': '36.95', 'estimateComment': '95% CI for difference in rates were constructed using Anderson-Hauck method.', 'groupDescription': 'P-value estimated using CMH test stratified by the IvRS randomization stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 15', 'description': 'MRD response rate was determined as the percentage of participants (with a CR/CRi) with MRD-negativity measured in the PB using NGS using a cutoff of \\< 10\\^-4. MRD was considered negative if the result was \\< 1 CLL cell in 10,000 leukocytes. CR/CRi were defined according to the iwCLL guidelines. CR was defined as one of the following: PB lymphocytes below 4 x 10\\^9 /L; absence of significant lymphadenopathy (nodes \\< 1.5 cm in LD or any extra nodal disease); no hepatomegaly; no splenomegaly; absence of disease or constitutional symptoms; BM at least normocellular for age, ≤30% of nucleated cells being lymphocytes. CRi was defined as participants fulfilling CR criteria but had persistent anemia, thrombocytopenia, or neutropenia. Percentages have been rounded off to the nearest decimal point.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, analyzed according to the treatment to which they were randomized. Overall number analyzed is the number of participants with CR/CRi.'}, {'type': 'SECONDARY', 'title': 'MRD Response Rate in BM of Participants With a CR/CRi at the End of Treatment Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: VEN+G', 'description': 'Participants received obinutuzumab, 1000 mg, as IV infusion on Days 1 (and 2), 8, and 15 of Cycle 1 and Day 1 of Cycles 2-6. Participants also received venetoclax, with a 5-week ramp-up period (20 mg \\[Cycle 1 Days 22-28\\], 50 mg \\[Cycle 2 Days 1-7\\], 100 mg \\[Cycle 2 Days 8-14\\], 200 mg \\[Cycle 2 Days 15-21\\], 400 mg \\[Cycle 2 Days 22-28\\]) administered orally, QD. After the 5-week ramp-up period, participants received venetoclax, 400 mg, orally, QD from Cycle 3 Day 1 until the end of Cycle 12. (1 cycle = 28 days).'}, {'id': 'OG001', 'title': 'Arm B: FCR/BR', 'description': 'Participants received rituximab (375 mg/m\\^2 in Cycle 1 and 500 mg/m\\^2 in Cycles 2-6), on Day 1 of each cycle, plus fludarabine 25 mg/m\\^2 and cyclophosphamide 250 mg/m\\^2 on Days 1, 2, and 3 of each cycle as IV infusion up to Cycle 6. Participants alternatively received bendamustine 90 mg/m\\^2 on Days 1 and 2 of Cycles 1-6 plus rituximab 375 mg/m\\^2 on Day 1 of Cycle 1 and 500 mg/m\\^2 on Day 1 of Cycles 2-6. (1 cycle = 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '73.20', 'upperLimit': '95.81'}, {'value': '60.7', 'groupId': 'OG001', 'lowerLimit': '40.58', 'upperLimit': '78.50'}]}]}], 'analyses': [{'pValue': '0.0038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.79', 'ciLowerLimit': '3.86', 'ciUpperLimit': '49.72', 'estimateComment': '95% CI for difference in rates were constructed using Anderson-Hauck method.', 'groupDescription': 'P-value estimated using CMH test stratified by the IvRS randomization stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'VEN+G: From Cycle 1 Day 1 up to 15 months; FCR/BR: From Cycle 1 Day 1 up to 9 months (1 cycle=28 days)', 'description': 'MRD response rate was determined as the percentage of participants (with CR/CRi) with MRD-negativity measured in the BM using NGS using a cutoff of \\< 10\\^-4. MRD was considered negative if the result was \\< 1 CLL cell in 10,000 leukocytes. CR/CRi were defined according to the iwCLL guidelines. CR was defined as one of the following: PB lymphocytes below 4 x 10\\^9 /L; absence of significant lymphadenopathy (nodes \\< 1.5 cm in LD or any extra nodal disease); no hepatomegaly; no splenomegaly; absence of disease or constitutional symptoms; BM at least normocellular for age, ≤30% of nucleated cells being lymphocytes. CRi was defined as participants fulfilling CR criteria with CR but had persistent anemia, thrombocytopenia, or neutropenia. Percentages have been rounded off to the nearest decimal point.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, analyzed according to the treatment to which they were randomized. Overall number analyzed is the number of participants with CR/CRi.'}, {'type': 'SECONDARY', 'title': 'Duration of Objective Response (DOR)', 'timeFrame': 'Up to approximately 74 months', 'description': 'DOR was defined as the time from the first occurrence of a documented OR (CR, CRi and PR) to the time of PD as determined by the investigator, or death from any cause, whichever occurs first. CR, CRi, PR, and PD were defined according to the iwCLL guidelines. PD was defined as any one of the following: appearance of any new lesion such as enlarged lymph nodes (≥ 1.5 cm); increase by ≥ 50% in greatest diameter of any previous site (≥ 1.5 cm); increase in the spleen/liver size by ≥ 50% or de novo appearance of splenomegaly/hepatomegaly; increase in blood lymphocytes by 50% or more with at least 5x10\\^9/L B lymphocytes; transformation to a more aggressive histology; occurrence of cytopenia; posttreatment: progression of any cytopenia, documented by a decrease of Hb ≥ 2 g/dL or 10 g/dL, or by a decrease of platelet counts ≥ 50%/100x10\\^9/L, which occurs at least 3 months after treatment. CR, CRi and PR were defined as outlined in the description for ORR outcome measure (OM) number 5.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-07'}, {'type': 'SECONDARY', 'title': 'Best Overall Response (BOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: VEN+G', 'description': 'Participants received obinutuzumab, 1000 mg, as IV infusion on Days 1 (and 2), 8, and 15 of Cycle 1 and Day 1 of Cycles 2-6. Participants also received venetoclax, with a 5-week ramp-up period (20 mg \\[Cycle 1 Days 22-28\\], 50 mg \\[Cycle 2 Days 1-7\\], 100 mg \\[Cycle 2 Days 8-14\\], 200 mg \\[Cycle 2 Days 15-21\\], 400 mg \\[Cycle 2 Days 22-28\\]) administered orally, QD. After the 5-week ramp-up period, participants received venetoclax, 400 mg, orally, QD from Cycle 3 Day 1 until the end of Cycle 12. (1 cycle = 28 days).'}, {'id': 'OG001', 'title': 'Arm B: FCR/BR', 'description': 'Participants received rituximab (375 mg/m\\^2 in Cycle 1 and 500 mg/m\\^2 in Cycles 2-6), on Day 1 of each cycle, plus fludarabine 25 mg/m\\^2 and cyclophosphamide 250 mg/m\\^2 on Days 1, 2, and 3 of each cycle as IV infusion up to Cycle 6. Participants alternatively received bendamustine 90 mg/m\\^2 on Days 1 and 2 of Cycles 1-6 plus rituximab 375 mg/m\\^2 on Day 1 of Cycle 1 and 500 mg/m\\^2 on Day 1 of Cycles 2-6. (1 cycle = 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '93.8', 'groupId': 'OG000', 'lowerLimit': '86.01', 'upperLimit': '97.94'}, {'value': '90.7', 'groupId': 'OG001', 'lowerLimit': '82.49', 'upperLimit': '95.90'}]}]}], 'analyses': [{'pValue': '0.4199', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.05', 'ciLowerLimit': '-5.73', 'ciUpperLimit': '11.84', 'estimateComment': '95% CI for difference in rates were constructed using Anderson-Hauck method.', 'groupDescription': 'P-value estimated using CMH test stratified by the IvRS randomization stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 15', 'description': 'BOR=percentage of participants with CR/CRi/PR/stable disease (SD)/PD per the investigator. Participants with best response as CR/CRi/PR were considered responders while those reaching SD/PD were non-responders. SD=participants who have not achieved a CR or a PR, or who have not exhibited PD. PD=any one of the following: appearance of any new lesion such as enlarged lymph nodes (≥ 1.5 cm); increase by ≥ 50% in greatest diameter of any previous site (≥ 1.5 cm); increase in the spleen/liver size by ≥ 50% or de novo appearance of splenomegaly/hepatomegaly; increase in blood lymphocytes by 50% or more with at least 5x10\\^9/L B lymphocytes; transformation to a more aggressive histology; occurrence of cytopenia; posttreatment: progression of any cytopenia, documented by a decrease of Hb ≥ 2 g/dL or 10 g/dL, or by a decrease of platelet counts ≥ 50%/100x10\\^9/L, which occurs at least 3 months after treatment. CR, CRi and PR were defined as outlined in the description for ORR, OM number 5.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, analyzed according to the treatment to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Event-free Survival (EFS)', 'timeFrame': 'Up to approximately 74 months', 'description': 'EFS was defined as the time between the date of randomization and the date of PD/relapse, death, or the start of a new anti-leukemic therapy. PD was defined as any one of the following: appearance of any new lesion such as enlarged lymph nodes (≥ 1.5 cm); increase by ≥ 50% in greatest diameter of any previous site (≥ 1.5 cm); increase in the spleen/liver size by ≥ 50% or de novo appearance of splenomegaly/hepatomegaly; increase in blood lymphocytes by 50% or more with at least 5x10\\^9/L B lymphocytes; transformation to a more aggressive histology; occurrence of cytopenia; posttreatment: progression of any cytopenia, documented by a decrease of Hb ≥ 2 g/dL or 10 g/dL, or by a decrease of platelet counts ≥ 50%/100x10\\^9/L, which occurs at least 3 months after treatment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-07'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 74 months', 'description': 'OS was defined as the time between the date of randomization and the date of death due to any cause.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-07'}, {'type': 'SECONDARY', 'title': 'VEN + G: Tumor Lysis Syndrome (TLS) Risk Reduction Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: VEN+G', 'description': 'Participants received obinutuzumab, 1000 mg, as IV infusion on Days 1 (and 2), 8, and 15 of Cycle 1 and Day 1 of Cycles 2-6. Participants also received venetoclax, with a 5-week ramp-up period (20 mg \\[Cycle 1 Days 22-28\\], 50 mg \\[Cycle 2 Days 1-7\\], 100 mg \\[Cycle 2 Days 8-14\\], 200 mg \\[Cycle 2 Days 15-21\\], 400 mg \\[Cycle 2 Days 22-28\\]) administered orally, QD. After the 5-week ramp-up period, participants received venetoclax, 400 mg, orally, QD from Cycle 3 Day 1 until the end of Cycle 12. (1 cycle = 28 days).'}], 'classes': [{'title': 'High-risk at Baseline', 'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000'}]}]}, {'title': 'High-risk at Cycle 1 Day 22', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Cycle 1 Day 22 (1 cycle=28 days)', 'description': 'TLS risk reduction rate in the VEN + G arm was defined as the reduction in the percentage of participants who were TLS high-risk after 3 doses of obinutuzumab compared to the percentage of participants who were TLS high-risk at baseline. Risk for developing TLS were categorised into: Low - All measurable lymph nodes with the LD \\< 5 cm and \\< 25x10\\^9/L absolute lymphocyte count (ALC); Medium - Any measurable lymph node with the LD ≥5 cm but \\<10 cm OR ≥25x10\\^9/L ALC; High - Any measurable lymph node with the LD ≥10 cm or the presence of both ≥25x10\\^9/L ALC and any measurable lymph node with the LD ≥5 cm but \\<10 cm. Percentages have been rounded off to the nearest decimal point.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, analyzed according to the treatment to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'VEN + G: Reduction in Mandatory Hospitalizations During Venetoclax Ramp-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: VEN+G', 'description': 'Participants received obinutuzumab, 1000 mg, as IV infusion on Days 1 (and 2), 8, and 15 of Cycle 1 and Day 1 of Cycles 2-6. Participants also received venetoclax, with a 5-week ramp-up period (20 mg \\[Cycle 1 Days 22-28\\], 50 mg \\[Cycle 2 Days 1-7\\], 100 mg \\[Cycle 2 Days 8-14\\], 200 mg \\[Cycle 2 Days 15-21\\], 400 mg \\[Cycle 2 Days 22-28\\]) administered orally, QD. After the 5-week ramp-up period, participants received venetoclax, 400 mg, orally, QD from Cycle 3 Day 1 until the end of Cycle 12. (1 cycle = 28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 Days 22-28 up to Cycle 2 Days 1-7 (1 cycle=28 days)', 'description': 'Reduction in mandatory hospitalizations during venetoclax ramp-up in the VEN + G arm participants was defined as the actual number of protocol-mandated hospitalizations for TLS monitoring during venetoclax ramp-up period after 3 doses of obinutuzumab compared to the number of protocol-mandated hospitalizations for TLS monitoring during venetoclax ramp-up expected at baseline. Ramp-up period for venetoclax was defined as period from Cycle 1, Days 22-28, and Cycle 2, Day 1-Day 7 where the 20 mg and 50 mg daily doses of venetoclax, were administered for participants at TLS-high risk requiring mandated hospitalizations (the hospitalizations at 100, 200 and 400 was only needed if the participant had a TLS event at one of the lower doses). Total number of hospitalizations in high-risk TLS participants at baseline (expected to be N=2 hospitalization) was compared with the number of protocol mandated hospitalizations during the first 2 doses of the ramp-up.', 'unitOfMeasure': 'number of hospitalizations', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants, analyzed according to the treatment to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From Day 1 until 28 days after the last dose of study drug, or until initiation of another anti-cancer therapy (up to 74 months)', 'description': "An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE was any AE that meets any of the following criteria: is fatal; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug; is a significant medical event in the investigator's judgment.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-07'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Premature Withdrawals Due to AEs', 'timeFrame': 'From Day 1 until 28 days after the last dose of study drug, or until initiation of another anti-cancer therapy (up to 74 months)', 'description': "An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE was any AE that meets any of the following criteria: is fatal; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug; is a significant medical event in the investigator's judgment.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-07'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Physical Functioning, Role Functioning and Health-Related Quality of Life (HRQoL) Assessed Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQC-30)', 'timeFrame': 'VEN + G: Day 1 of Cycle 1-12, Day 28 after treatment completion/early termination (TC/ET), follow up (FU) visits; FCR/BR: Day 1 of Cycle 1-6, Day 28 after TC/ET, end of combination treatment response visit and FU visit (up to 74 months) (1 cycle=28 days)', 'description': 'The EORTC QLQ-C30 consists of 30 questions incorporated into five functional scales (physical, role, cognitive, emotional and social scales), three symptom scales (fatigue, pain, nausea, and vomiting scales), a global health status/global quality-of-life (GHS/QoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The 28 function and symptom items were scored on a 4-point scale that ranged from "not at all" to "very much," and the 2 GHS/QoL items were scored on a 7-point scale that ranged from "very poor" to "excellent." Raw average scale scores were linearly transformed to range 0-100 with higher scores indicating higher response levels (i.e. higher functioning, higher symptom severity).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-07'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in M.D. Anderson Symptom Inventory-CLL (MDASI-CLL) Score', 'timeFrame': 'VEN + G: Day 1 of Cycle 1-12, Day 28 after TC/ET, FU visits; FCR/BR: Day 1 of Cycle 1-6, Day 28 after TC/ET, end of combination treatment response visit and FU visit (up to approximately 74 months) (1 cycle=28 days)', 'description': 'MDASI-CLL consists of 25 items over 3 scales that assess core cancer \\& CLL-related symptom severity, as well as symptom interference that a participant may have experienced in past 24 hours. Participants were asked to rate severity of 13 symptoms called mean core symptom severity (pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting \\& numbness/tingling), 6 disease-specific symptoms called mean module symptom severity (night sweats, fever \\& chills, lymph node swelling, diarrhea, easy bruising/bleeding \\& constipation) \\& 6 mean interference on life questions (general activity, walking, work, mood, relations with other people \\& enjoyment of life) on a scale from 0-10 with 0 indicating that symptom is "not present" or "did not interfere" with participant\'s activities \\& 10 indicating "as bad as you can imagine" or "interfered completely". Lower scores indicated lower symptom severity/interference.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-07'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: VEN+G', 'description': 'Participants received obinutuzumab, 1000 milligrams (mg), as intravenous (IV) infusion on Days 1 (and 2), 8, and 15 of Cycle 1 and Day 1 of Cycles 2-6. Participants also received venetoclax, with a 5-week ramp-up period (20 mg \\[Cycle 1 Days 22-28\\], 50 mg \\[Cycle 2 Days 1-7\\], 100 mg \\[Cycle 2 Days 8-14\\], 200 mg \\[Cycle 2 Days 15-21\\], 400 mg \\[Cycle 2 Days 22-28\\]) administered orally, once a day (QD). After the 5-week ramp-up period, participants received venetoclax, 400 mg, orally, QD from Cycle 3 Day 1 until the end of Cycle 12. (1 cycle = 28 days).'}, {'id': 'FG001', 'title': 'Arm B: FCR/BR', 'description': 'Participants received rituximab (375 milligrams per meter square \\[mg/m\\^2\\] in Cycle 1 and 500 mg/m\\^2 in Cycles 2-6), on Day 1 of each cycle, plus fludarabine 25 mg/m\\^2 and cyclophosphamide 250 mg/m\\^2 on Days 1, 2, and 3 of each cycle as IV infusion up to Cycle 6. Participants alternatively received bendamustine 90 mg/m\\^2 on Days 1 and 2 of Cycles 1-6 plus rituximab 375 mg/m\\^2 on Day 1 of Cycle 1 and 500 mg/m\\^2 on Day 1 of Cycles 2-6. (1 cycle = 28 days).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '86'}]}, {'type': 'Safety Population', 'comment': 'Safety Population included all participants who received at least one dose of any study medication. Participants were analyzed according to the treatment that they actually received.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '85'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '86'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participants Ongoing in Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '74'}]}]}], 'recruitmentDetails': 'A total of 166 participants took part in this study which was conducted at 38 investigative sites in France, Italy, Australia, Spain, and the United States. The study is still ongoing.', 'preAssignmentDetails': "Participants with previously untreated chronic lymphocytic leukemia (CLL) without del (17p) or tumor protein p53 (TP53) mutation were randomized in a 1:1 ratio to receive either venetoclax + obinutuzumab (VEN+G) or fludarabine, cyclophosphamide, and rituximab/bendamustine and rituximab (FCR/BR). All participants in FCR/BR arm were eligible for treatment with BR, whereas only participants ≤ 65 years were eligible for FCR. The choice between FCR or BR was at the investigator's discretion."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: VEN+G', 'description': 'Participants received obinutuzumab, 1000 mg, as IV infusion on Days 1 (and 2), 8, and 15 of Cycle 1 and Day 1 of Cycles 2-6. Participants also received venetoclax, with a 5-week ramp-up period (20 mg \\[Cycle 1 Days 22-28\\], 50 mg \\[Cycle 2 Days 1-7\\], 100 mg \\[Cycle 2 Days 8-14\\], 200 mg \\[Cycle 2 Days 15-21\\], 400 mg \\[Cycle 2 Days 22-28\\]) administered orally, QD. After the 5-week ramp-up period, participants received venetoclax, 400 mg, orally, QD from Cycle 3 Day 1 until the end of Cycle 12. (1 cycle = 28 days).'}, {'id': 'BG001', 'title': 'Arm B: FCR/BR', 'description': 'Participants received rituximab (375 mg/m\\^2 in Cycle 1 and 500 mg/m\\^2 in Cycles 2-6), on Day 1 of each cycle, plus fludarabine 25 mg/m\\^2 and cyclophosphamide 250 mg/m\\^2 on Days 1, 2, and 3 of each cycle as IV infusion up to Cycle 6. Participants alternatively received bendamustine 90 mg/m\\^2 on Days 1 and 2 of Cycles 1-6 plus rituximab 375 mg/m\\^2 on Day 1 of Cycle 1 and 500 mg/m\\^2 on Day 1 of Cycles 2-6. (1 cycle = 28 days).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '61.0', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '61.2', 'spread': '8.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS) included all randomized participants, analyzed according to the treatment to which they were randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-07', 'size': 4367232, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-13T07:03', 'hasProtocol': True}, {'date': '2024-03-13', 'size': 967414, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-13T07:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2020-02-25', 'resultsFirstSubmitDate': '2025-03-13', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-04-16', 'studyFirstPostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minimal Residual Disease (MRD) Response Rate Measured in Peripheral Blood (PB) Using Next Generation Sequencing (NGS)', 'timeFrame': 'At Month 15', 'description': 'MRD response rate was determined as the percentage of participants with MRD-negativity measured in the PB using NGS using a cutoff of \\< 10\\^-4. MRD was considered negative if the result was \\< 1 CLL cell in 10,000 leukocytes. Percentages have been rounded off to the nearest decimal point.'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Up to approximately 74 months', 'description': 'PFS was defined as the time from randomization to the first occurrence of disease progression (PD), or death from any cause. PD was assessed by the investigators using the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. PD was defined as any one of the following: Appearance of any new lesion such as enlarged lymph nodes (≥ 1.5 centimeters \\[cm\\]); increase by ≥ 50% in greatest diameter of any previous site (≥ 1.5 cm); increase in the spleen/liver size by ≥ 50% or de novo appearance of splenomegaly/hepatomegaly; increase in blood lymphocytes by 50% or more with at least 5x10\\^9/litres (L) B lymphocytes; transformation to a more aggressive histology; occurrence of cytopenia; posttreatment: progression of any cytopenia, documented by a decrease of hemoglobin (Hb) ≥ 2 grams per deciliter (g/dL) or 10 g/dL, or by a decrease of platelet counts ≥ 50%/100x10\\^9/L, which occurs at least 3 months after treatment.'}, {'measure': 'MRD Response Rate in PB of FCR/BR Compared With VEN+G at the End of Treatment Response Visit', 'timeFrame': 'VEN+G: From Cycle 1 Day 1 up to 15 months; FCR/BR: From Cycle 1 Day 1 up to 9 months (1 cycle=28 days)', 'description': 'MRD response rate was determined as the percentage of participants with MRD-negativity measured in the PB using NGS using a cutoff of \\< 10\\^-4. MRD was considered negative if the result was \\< 1 CLL cell in 10,000 leukocytes. Percentages have been rounded off to the nearest decimal point.'}, {'measure': 'MRD Response Rate in Bone Marrow (BM) of FCR/BR Compared With VEN+G at the End of Treatment Response Visit', 'timeFrame': 'VEN+G: From Cycle 1 Day 1 up to 15 months; FCR/BR: From Cycle 1 Day 1 up to 9 months (1 cycle=28 days)', 'description': 'MRD response rate=percentage of participants with MRD-negativity measured in BM using NGS (cutoff of \\<10\\^-4). MRD negativity=\\<1 CLL cell in 10,000 leukocytes. MRD in BM was assessed for participants with complete response (CR)/CR with incomplete blood count recovery (CRi) \\& partial response (PR). CR=PB lymphocytes \\<4x10\\^9 /L; Absence of significant lymphadenopathy (nodes \\<1.5 cm in longest diameter); no hepatomegaly/splenomegaly; absence of disease/constitutional symptoms; BM at least normocellular for age, ≤30% of nucleated cells being lymphocytes. CRi=fulfilling CR criteria but with persistent anemia/thrombocytopenia/neutropenia. PR= ≥50% decrease in PB lymphocyte count from pre-treatment value; ≥50% reduction in lymphadenopathy (sum of longest diameter of up to 6 largest lymph nodes by physical exam \\& 50% reduction in the sum of product of the diameter of up to 6 largest lymph nodes); ≥50% reduction of liver/spleen enlargement/normalization in size, if enlarged at baseline.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'At Month 15', 'description': 'ORR was defined as the percentage of participants with overall response (OR) of CR, CRi, and PR as determined by the investigator according to the iwCLL guidelines. CR was defined as PB lymphocytes \\<4x10\\^9 /L; absence of significant lymphadenopathy (nodes \\<1.5 cm in longest diameter \\[LD\\]); no hepatomegaly/splenomegaly; absence of disease/constitutional symptoms; BM at least normocellular for age, ≤30% of nucleated cells being lymphocytes. CRi was defined as fulfilling CR criteria but with persistent anemia/thrombocytopenia/neutropenia. PR was defined as ≥50% decrease in PB lymphocyte count from pre-treatment value; ≥50% reduction in lymphadenopathy sum of longest diameter of up to 6 largest lymph nodes by physical exam and 50% reduction in the sum of product of the diameter of up to 6 largest lymph nodes); ≥50% reduction of liver/spleen enlargement/normalization in size, if enlarged at baseline.'}, {'measure': 'CR Rate', 'timeFrame': 'At Month 15', 'description': 'CR rate was defined as the percentage of participants with CR or CRi. CR/CRi were defined according to the iwCLL guidelines. CR was defined as one of the following: PB lymphocytes (evaluated by blood and differential count) below 4 x 10\\^9 /L; absence of significant lymphadenopathy (nodes \\< 1.5 cm in LD or any extra nodal disease); no hepatomegaly; no splenomegaly; absence of disease or constitutional symptoms; BM at least normocellular for age, ≤30% of nucleated cells being lymphocytes. CRi was defined as participants fulfilling CR criteria but had persistent anemia, thrombocytopenia, or neutropenia. Percentages have been rounded off to the nearest decimal point.'}, {'measure': 'MRD Response Rate in PB of Participants With a CR/CRi at the End of Treatment Visit', 'timeFrame': 'At Month 15', 'description': 'MRD response rate was determined as the percentage of participants (with a CR/CRi) with MRD-negativity measured in the PB using NGS using a cutoff of \\< 10\\^-4. MRD was considered negative if the result was \\< 1 CLL cell in 10,000 leukocytes. CR/CRi were defined according to the iwCLL guidelines. CR was defined as one of the following: PB lymphocytes below 4 x 10\\^9 /L; absence of significant lymphadenopathy (nodes \\< 1.5 cm in LD or any extra nodal disease); no hepatomegaly; no splenomegaly; absence of disease or constitutional symptoms; BM at least normocellular for age, ≤30% of nucleated cells being lymphocytes. CRi was defined as participants fulfilling CR criteria but had persistent anemia, thrombocytopenia, or neutropenia. Percentages have been rounded off to the nearest decimal point.'}, {'measure': 'MRD Response Rate in BM of Participants With a CR/CRi at the End of Treatment Visit', 'timeFrame': 'VEN+G: From Cycle 1 Day 1 up to 15 months; FCR/BR: From Cycle 1 Day 1 up to 9 months (1 cycle=28 days)', 'description': 'MRD response rate was determined as the percentage of participants (with CR/CRi) with MRD-negativity measured in the BM using NGS using a cutoff of \\< 10\\^-4. MRD was considered negative if the result was \\< 1 CLL cell in 10,000 leukocytes. CR/CRi were defined according to the iwCLL guidelines. CR was defined as one of the following: PB lymphocytes below 4 x 10\\^9 /L; absence of significant lymphadenopathy (nodes \\< 1.5 cm in LD or any extra nodal disease); no hepatomegaly; no splenomegaly; absence of disease or constitutional symptoms; BM at least normocellular for age, ≤30% of nucleated cells being lymphocytes. CRi was defined as participants fulfilling CR criteria with CR but had persistent anemia, thrombocytopenia, or neutropenia. Percentages have been rounded off to the nearest decimal point.'}, {'measure': 'Duration of Objective Response (DOR)', 'timeFrame': 'Up to approximately 74 months', 'description': 'DOR was defined as the time from the first occurrence of a documented OR (CR, CRi and PR) to the time of PD as determined by the investigator, or death from any cause, whichever occurs first. CR, CRi, PR, and PD were defined according to the iwCLL guidelines. PD was defined as any one of the following: appearance of any new lesion such as enlarged lymph nodes (≥ 1.5 cm); increase by ≥ 50% in greatest diameter of any previous site (≥ 1.5 cm); increase in the spleen/liver size by ≥ 50% or de novo appearance of splenomegaly/hepatomegaly; increase in blood lymphocytes by 50% or more with at least 5x10\\^9/L B lymphocytes; transformation to a more aggressive histology; occurrence of cytopenia; posttreatment: progression of any cytopenia, documented by a decrease of Hb ≥ 2 g/dL or 10 g/dL, or by a decrease of platelet counts ≥ 50%/100x10\\^9/L, which occurs at least 3 months after treatment. CR, CRi and PR were defined as outlined in the description for ORR outcome measure (OM) number 5.'}, {'measure': 'Best Overall Response (BOR)', 'timeFrame': 'At Month 15', 'description': 'BOR=percentage of participants with CR/CRi/PR/stable disease (SD)/PD per the investigator. Participants with best response as CR/CRi/PR were considered responders while those reaching SD/PD were non-responders. SD=participants who have not achieved a CR or a PR, or who have not exhibited PD. PD=any one of the following: appearance of any new lesion such as enlarged lymph nodes (≥ 1.5 cm); increase by ≥ 50% in greatest diameter of any previous site (≥ 1.5 cm); increase in the spleen/liver size by ≥ 50% or de novo appearance of splenomegaly/hepatomegaly; increase in blood lymphocytes by 50% or more with at least 5x10\\^9/L B lymphocytes; transformation to a more aggressive histology; occurrence of cytopenia; posttreatment: progression of any cytopenia, documented by a decrease of Hb ≥ 2 g/dL or 10 g/dL, or by a decrease of platelet counts ≥ 50%/100x10\\^9/L, which occurs at least 3 months after treatment. CR, CRi and PR were defined as outlined in the description for ORR, OM number 5.'}, {'measure': 'Event-free Survival (EFS)', 'timeFrame': 'Up to approximately 74 months', 'description': 'EFS was defined as the time between the date of randomization and the date of PD/relapse, death, or the start of a new anti-leukemic therapy. PD was defined as any one of the following: appearance of any new lesion such as enlarged lymph nodes (≥ 1.5 cm); increase by ≥ 50% in greatest diameter of any previous site (≥ 1.5 cm); increase in the spleen/liver size by ≥ 50% or de novo appearance of splenomegaly/hepatomegaly; increase in blood lymphocytes by 50% or more with at least 5x10\\^9/L B lymphocytes; transformation to a more aggressive histology; occurrence of cytopenia; posttreatment: progression of any cytopenia, documented by a decrease of Hb ≥ 2 g/dL or 10 g/dL, or by a decrease of platelet counts ≥ 50%/100x10\\^9/L, which occurs at least 3 months after treatment.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 74 months', 'description': 'OS was defined as the time between the date of randomization and the date of death due to any cause.'}, {'measure': 'VEN + G: Tumor Lysis Syndrome (TLS) Risk Reduction Rate', 'timeFrame': 'Baseline up to Cycle 1 Day 22 (1 cycle=28 days)', 'description': 'TLS risk reduction rate in the VEN + G arm was defined as the reduction in the percentage of participants who were TLS high-risk after 3 doses of obinutuzumab compared to the percentage of participants who were TLS high-risk at baseline. Risk for developing TLS were categorised into: Low - All measurable lymph nodes with the LD \\< 5 cm and \\< 25x10\\^9/L absolute lymphocyte count (ALC); Medium - Any measurable lymph node with the LD ≥5 cm but \\<10 cm OR ≥25x10\\^9/L ALC; High - Any measurable lymph node with the LD ≥10 cm or the presence of both ≥25x10\\^9/L ALC and any measurable lymph node with the LD ≥5 cm but \\<10 cm. Percentages have been rounded off to the nearest decimal point.'}, {'measure': 'VEN + G: Reduction in Mandatory Hospitalizations During Venetoclax Ramp-up', 'timeFrame': 'Cycle 1 Days 22-28 up to Cycle 2 Days 1-7 (1 cycle=28 days)', 'description': 'Reduction in mandatory hospitalizations during venetoclax ramp-up in the VEN + G arm participants was defined as the actual number of protocol-mandated hospitalizations for TLS monitoring during venetoclax ramp-up period after 3 doses of obinutuzumab compared to the number of protocol-mandated hospitalizations for TLS monitoring during venetoclax ramp-up expected at baseline. Ramp-up period for venetoclax was defined as period from Cycle 1, Days 22-28, and Cycle 2, Day 1-Day 7 where the 20 mg and 50 mg daily doses of venetoclax, were administered for participants at TLS-high risk requiring mandated hospitalizations (the hospitalizations at 100, 200 and 400 was only needed if the participant had a TLS event at one of the lower doses). Total number of hospitalizations in high-risk TLS participants at baseline (expected to be N=2 hospitalization) was compared with the number of protocol mandated hospitalizations during the first 2 doses of the ramp-up.'}, {'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From Day 1 until 28 days after the last dose of study drug, or until initiation of another anti-cancer therapy (up to 74 months)', 'description': "An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE was any AE that meets any of the following criteria: is fatal; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug; is a significant medical event in the investigator's judgment."}, {'measure': 'Number of Participants With Premature Withdrawals Due to AEs', 'timeFrame': 'From Day 1 until 28 days after the last dose of study drug, or until initiation of another anti-cancer therapy (up to 74 months)', 'description': "An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE was any AE that meets any of the following criteria: is fatal; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug; is a significant medical event in the investigator's judgment."}, {'measure': 'Change From Baseline in Physical Functioning, Role Functioning and Health-Related Quality of Life (HRQoL) Assessed Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQC-30)', 'timeFrame': 'VEN + G: Day 1 of Cycle 1-12, Day 28 after treatment completion/early termination (TC/ET), follow up (FU) visits; FCR/BR: Day 1 of Cycle 1-6, Day 28 after TC/ET, end of combination treatment response visit and FU visit (up to 74 months) (1 cycle=28 days)', 'description': 'The EORTC QLQ-C30 consists of 30 questions incorporated into five functional scales (physical, role, cognitive, emotional and social scales), three symptom scales (fatigue, pain, nausea, and vomiting scales), a global health status/global quality-of-life (GHS/QoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The 28 function and symptom items were scored on a 4-point scale that ranged from "not at all" to "very much," and the 2 GHS/QoL items were scored on a 7-point scale that ranged from "very poor" to "excellent." Raw average scale scores were linearly transformed to range 0-100 with higher scores indicating higher response levels (i.e. higher functioning, higher symptom severity).'}, {'measure': 'Change From Baseline in M.D. Anderson Symptom Inventory-CLL (MDASI-CLL) Score', 'timeFrame': 'VEN + G: Day 1 of Cycle 1-12, Day 28 after TC/ET, FU visits; FCR/BR: Day 1 of Cycle 1-6, Day 28 after TC/ET, end of combination treatment response visit and FU visit (up to approximately 74 months) (1 cycle=28 days)', 'description': 'MDASI-CLL consists of 25 items over 3 scales that assess core cancer \\& CLL-related symptom severity, as well as symptom interference that a participant may have experienced in past 24 hours. Participants were asked to rate severity of 13 symptoms called mean core symptom severity (pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting \\& numbness/tingling), 6 disease-specific symptoms called mean module symptom severity (night sweats, fever \\& chills, lymph node swelling, diarrhea, easy bruising/bleeding \\& constipation) \\& 6 mean interference on life questions (general activity, walking, work, mood, relations with other people \\& enjoyment of life) on a scale from 0-10 with 0 indicating that symptom is "not present" or "did not interfere" with participant\'s activities \\& 10 indicating "as bad as you can imagine" or "interfered completely". Lower scores indicated lower symptom severity/interference.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Lymphocytic Leukemia (CLL)']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of venetoclax and obinutuzumab (VEN + G) compared with fludarabine + cyclophosphamide + rituximab or bendamustine + rituximab (FCR/BR) in FIT participants (FIT is defined by a cumulative illness rating scale \\[CIRS\\]/score of ≤6 and a normal creatinine clearance of ≥70 mL/min) with previously untreated CLL without DEL(17P) or TP53 mutation requiring treatment. Eligible participants will be randomly assigned in a 1:1 ratio to receive either VEN + G (Arm A) or FCR/BR (Arm B).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ability to comply with the study protocol, in the investigator's judgment\n* Aged 18 years or older\n* Have previously untreated documented Chronic Lymphocytic Leukemia (CLL) according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria\n* CLL requiring treatment according to the iwCLL criteria\n* Cumulative Illness Rating Scale (CIRS) score ≤ 6 and creatinine clearance (CrCl) ≥ 70 mL/min\n* Hematology values within the following limits, unless cytopenia is caused by the underlying disease (i.e., no evidence of additional bone marrow (BM) dysfunction; e.g., myelodysplastic syndrome, hypoplastic BM):\n\n * Absolute neutrophil count ≥ 1.0 x 109/L, unless there is BM involvement\n * Platelet count ≥ 75 x 109/L and more than 7 days since last transfusion, or ≥ 30 x 109/L if there is BM involvement\n* Adequate liver function as indicated by a total bilirubin, aspartate aminotransferase, and Alanine transaminase ≤ 2 times the institutional upper limit of normal (ULN) value, unless directly attributable to the participant's CLL\n* Life expectancy \\>6 months\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm\n\nExclusion Criteria:\n\n* Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL)\n* Participants with Small Lymphocyclic Lymphoma (SLL) only\n* Known central nervous system involvement\n* Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML)\n* Detected del(17p) or TP53 mutation (valid test within 6-months from screening is required for randomisation)\n* An individual organ/system impairment score of 4 as assessed by the Cumulative Illness Rating Scale (CIRS) definition limiting the ability to receive the treatment regimen of this trial with the exception of eyes, ears, nose, throat organ system\n* Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia\n* History of prior malignancy\n* Participants with infections requiring IV treatment (Grade 3 or 4) within the last 8 weeks prior to enrollment\n* Evidence of other clinically significant uncontrolled conditions including but not limited to active or uncontrolled systemic infection (e.g., viral, bacterial, or fungal)\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products\n* Hypersensitivity to fludarabine, bendamustine, cyclophosphamide, rituximab, obinutuzumab, or venetoclax or to any of the excipients (e.g., trehalose)\n* Pregnant women and nursing mothers\n* Vaccination with a live vaccine ≤ 28 days prior to randomization\n* Prisoners or participants who are institutionalized by regulatory or court order or persons who are in dependence to the Sponsor or an investigator\n* History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment\n* Positive test results for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen \\[HBsAg\\] serology)\n* Positive test result for hepatitis C (hepatitis C virus \\[HCV\\] antibody serology testing)\n* Participants with known infection with HIV or Human T-Cell Leukemia Virus 1 (HTLV-1)\n* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study\n* Received any of the following agents within 28 days prior to the first dose of study treatment:\n\n * Immunotherapy\n * Radiotherapy\n * Hormone therapy\n * Any therapies intended for the treatment of lymphoma/leukemia whether approved or experimental\n* Participants who have received the following agents:\n\n * Strong and moderate CYP3A inhibitors/inducers within 7 days prior to the initiation of study treatment\n * Steroid therapy for anti-neoplastic intent with the exception of inhaled steroids for asthma, topical steroids, or replacement/stress corticosteroids within 7 days prior to the first dose of study drug administration\n * Consumed grapefruit, grapefruit products, Seville oranges(including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of study drug and throughout venetoclax administration\n* Inability to swallow a large number of tablets."}, 'identificationModule': {'nctId': 'NCT04285567', 'acronym': 'CRISTALLO', 'briefTitle': 'A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Prospective, Open-Label, Multicenter Randomized Phase III Study to Compare The Efficacy and Safety of A Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/Bendamustine and Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL(17P) or TP53 Mutation', 'orgStudyIdInfo': {'id': 'CO41685'}, 'secondaryIdInfos': [{'id': '2019-003327-37', 'type': 'EUDRACT_NUMBER'}, {'id': '2023-504036-17-00', 'type': 'OTHER', 'domain': 'EU CT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VEN + G', 'description': 'Participants will receive 12 cycles of treatment (each cycle is 28 days). Venetoclax (VEN) will be administered orally, daily, with a 5-week ramp-up period, starting on Cycle 1, Day 22 and administration will continue until the end of Cycle 12. Obinutuzumab (G) will be administered intravenously (IV) on Days 1 (and 2), 8, and 15 of Cycle 1 and on Day 1 of Cycles 2-6.', 'interventionNames': ['Drug: Obinutuzumab', 'Drug: Venetoclax']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FCR/BR', 'description': 'Participants will receive 6 cycles of Fludarabine + Cyclophosphamide + Rituximab (FCR) consisting of a single cycle of a single infusion of rituximab on Day 1 and fludarabine and cyclophosphamide infusions on Days 1-3 of each 28-day cycle or bendamustine (B) as infusions on Days 1 and 2 and a single cycle of rituximab on Day 1 of each 28-day cycle.', 'interventionNames': ['Drug: Fludarabine', 'Drug: Cyclophosphamide', 'Drug: Rituximab', 'Drug: Bendamustine']}], 'interventions': [{'name': 'Obinutuzumab', 'type': 'DRUG', 'otherNames': ['Gazyva', 'RO5072759', 'GA101'], 'description': 'Obinutuzumab 1000 milligrams (mg) will be administered IV on Days 1 (and 2), 8, and 15 of Cycle 1 and on Day 1 of Cycles 2-6.', 'armGroupLabels': ['VEN + G']}, {'name': 'Venetoclax', 'type': 'DRUG', 'otherNames': ['Venclexta', 'RO5537382', 'GDC-0199'], 'description': 'Venetoclax 20 mg will be administered orally, once daily starting on Day 22 of Cycle 1 for 7 days, then ramp up from 50 to 400 mg/day during Cycle 2 and continue at 400 mg/day from Day 1 of Cycle 3 till end of Cycle 12.', 'armGroupLabels': ['VEN + G']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Fludarabine will be administered in a dosage of 25 milligram per meter squared (mg/m\\^2), IV, on days 1, 2, and 3 of Cycles 1-6.', 'armGroupLabels': ['FCR/BR']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Cyclophosphamide will be administered in a dosage of 250 mg/m\\^2, IV, on Days 1, 2, and 3 Cycles 1-6.', 'armGroupLabels': ['FCR/BR']}, {'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['MabThera', 'Rituxan'], 'description': 'Rituximab will be administered at a dose of 375 mg/m\\^2, IV, on Cycle 1, Day 1 followed by 500 mg/m\\^2 on Day 1 of Cycles 2-6.', 'armGroupLabels': ['FCR/BR']}, {'name': 'Bendamustine', 'type': 'DRUG', 'otherNames': ['Treanda', 'Levact', 'Ribomustin'], 'description': 'Bendamustine will be administered at a dose of 90 mg/m\\^2, IV, on 2 consecutive days of Cycles 1-6.', 'armGroupLabels': ['FCR/BR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Medical Center of Aurora', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'American Oncology Partners of Maryland, PA', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee Medical Center;Office of Clinical Trials', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '24014', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Oncology & Hematology Associates of Southwest Virginia, Inc._Goldschmidt', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'zip': '2605', 'city': 'Canberra', 'state': 'Australian Capital Territory', 'country': 'Australia', 'facility': 'Canberra Hospital', 'geoPoint': {'lat': -35.28346, 'lon': 149.12807}}, {'zip': '2170', 'city': 'Liverpool', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Liverpool Hospital', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, {'zip': '2444', 'city': 'Port Macquarie', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Port Macquarie - Mid North Coast Cancer Institute', 'geoPoint': {'lat': -31.43084, 'lon': 152.90894}}, {'zip': '2065', 'city': 'St Leonards', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal North Shore Hospital', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}, {'zip': '7000', 'city': 'Hobart', 'state': 'Tasmania', 'country': 'Australia', 'facility': 'Royal Hobart Hospital', 'geoPoint': {'lat': -42.87936, 'lon': 147.32941}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Health;Haematology Research', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '3050', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre;Clinical Haematology', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3076', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Northern Hospital;Oncology and/or Hematology', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '33600', 'city': 'Pessac', 'state': 'Aquitaine', 'country': 'France', 'facility': 'Hopital Haut Leveque Chu de Bordeaux', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '37032', 'city': 'Tours', 'state': 'Indre-et-Loire', 'country': 'France', 'facility': 'Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau;Hématologie et Thérapie Cellulaire', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '66046', 'city': 'Perpignan', 'state': 'Languedoc-Roussillon', 'country': 'France', 'facility': 'Centre Hospitalier de Pérpignan;hématologie', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'zip': '59037', 'city': 'Lille', 'state': 'Nord', 'country': 'France', 'facility': 'Hopital Claude Huriez - CHU de Lille;service maladies appareil digestif', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '83100', 'city': 'Toulon', 'state': "Provence-Alpes-Côte d'Azur Region", 'country': 'France', 'facility': 'Centre Hospitalier intercommunal de Toulon La Seyne sur Mer', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'zip': '69310', 'city': 'Pierre-Bénite', 'state': 'Rhône', 'country': 'France', 'facility': 'centre hospitalier lyon sud;Service Hématologie', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '94000', 'city': 'Créteil', 'state': 'Val-de-Marne', 'country': 'France', 'facility': "HENRI MONDOR HOSPITAL;Centre d'investigation clinique", 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '14000', 'city': 'Caen', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Caen Normandie', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '72000', 'city': 'Le Mans', 'country': 'France', 'facility': 'Clinique Victor Hugo- CCS du Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Reims - 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Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).\n\nFor further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}