Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2026-03-01 @ 9:32 AM
Study NCT ID:
NCT00877006
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2009-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Bendamustine Hydrochloride and Rituximab (BR) Compared With R-CVP or R-CHOP in the First-Line Treatment of Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL) - Referred to as the BRIGHT Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069461', 'term': 'Bendamustine Hydrochloride'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}], 'ancestors': [{'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialqueries@tevausa.com', 'phone': '1-866-384-5525', 'title': 'Manager', 'organization': 'Teva Pharmaceuticals USA'}, 'certainAgreement': {'otherDetails': "Investigator/Institution must submit proposed publication to Sponsor for review within a prespecified number of days before submission for publication. If Sponsor's review shows that potentially patentable subject matter would be disclosed, publication/public disclosure shall be delayed to enable Sponsor, or Sponsor's designees, to file necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment Period: 32 weeks No adverse event data was collected during the 5-year Long-Term Follow-Up Period', 'description': 'Events are reported for the safety analysis set (participants who received at least 1 dose of study drug).', 'eventGroups': [{'id': 'EG000', 'title': 'Bendamustine and Rituximab (BR)', 'description': 'Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\\^2 IV on Day 1.', 'otherNumAtRisk': 221, 'otherNumAffected': 216, 'seriousNumAtRisk': 221, 'seriousNumAffected': 60}, {'id': 'EG001', 'title': 'R-CHOP/CVP', 'description': 'Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.\n\nR-CHOP: rituximab 375 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\\^2 IV Day 1; cyclophosphamide 750 mg/m\\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5\n\nR-CVP: rituximab 375 mg/m\\^2 IV on Day 1; cyclophosphamide 750 mg/m\\^2 IV on Day 1 or cyclophosphamide 1000 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5', 'otherNumAtRisk': 215, 'otherNumAffected': 211, 'seriousNumAtRisk': 215, 'seriousNumAffected': 49}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 63, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 69, 'numAffected': 29}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 79, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 88, 'numAffected': 22}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 104, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 44, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 251, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 255, 'numAffected': 85}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 67, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 54, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 33, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 31, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 85, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 121, 'numAffected': 90}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 65, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 72, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 29, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 255, 'numAffected': 139}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 139, 'numAffected': 102}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 86, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 35, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 24, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 34, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 179, 'numAffected': 113}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 147, 'numAffected': 107}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 36, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 23, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 27, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 45, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 31, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 32, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 26, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 115, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 64, 'numAffected': 45}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 18, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 57, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 26, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 33, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 46, 'numAffected': 32}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 26, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 39, 'numAffected': 27}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 23, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 31, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 29, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 32, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 60, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 68, 'numAffected': 45}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 77, 'numAffected': 51}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 29, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 42, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 53, 'numAffected': 47}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 37, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 36, 'numAffected': 34}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 23, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 28, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 83, 'numAffected': 74}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 26, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 40, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 215, 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'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 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'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dystonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Renal tubular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Complete Response (CR) at End of Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendamustine and Rituximab (BR)', 'description': 'Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\\^2 IV on Day 1.'}, {'id': 'OG001', 'title': 'R-CHOP/R-CVP', 'description': 'Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.\n\nR-CHOP: rituximab 375 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\\^2 IV Day 1; cyclophosphamide 750 mg/m\\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5\n\nR-CVP: rituximab 375 mg/m\\^2 IV on Day 1; cyclophosphamide 750 mg/m\\^2 IV on Day 1 or cyclophosphamide 1000 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000', 'lowerLimit': '25.3', 'upperLimit': '38.2'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '19.5', 'upperLimit': '31.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 21 or 28-day cycles (18-32 weeks)', 'description': 'CR=complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present pretherapy; protocol-specified positron emission tomography (PET) scan assessment criteria; (if the spleen and/or liver were enlarged on the basis of physical examination and/or anatomic imaging before treatment) the liver and/or spleen were considered normal size on physical examination and by anatomic imaging after therapy, with disappearance of all nodules related to lymphoma; (if the bone marrow was involved by lymphoma before treatment) the infiltrate must have cleared on subsequent bone marrow biopsies.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable Analysis Set: treated participants with a baseline and \\>=1 post-baseline response evaluation (based on computed tomography/magnetic resonance imaging \\[CT/MRI\\] or positron emission tomography \\[PET\\] and clinical data), or who discontinued treatment due to progressive disease and had no major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Overall Response at End of Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendamustine and Rituximab (BR)', 'description': 'Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\\^2 IV on Day 1.'}, {'id': 'OG001', 'title': 'R-CHOP/R-CVP', 'description': 'Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.\n\nR-CHOP: rituximab 375 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\\^2 IV Day 1; cyclophosphamide 750 mg/m\\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5\n\nR-CVP: rituximab 375 mg/m\\^2 IV on Day 1; cyclophosphamide 750 mg/m\\^2 IV on Day 1 or cyclophosphamide 1000 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5'}], 'classes': [{'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '93.3', 'upperLimit': '98.7'}, {'value': '91', 'groupId': 'OG001', 'lowerLimit': '86.0', 'upperLimit': '94.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 21 or 28-day cycles (18-32 weeks)', 'description': 'Overall Response=participants with Complete Remission (CR) + those with Partial Remission (PR). CR=see Outcome Measure 1 for details. PR= at least a 50% decrease in the sum of the product of the greatest diameters (SPD) of up to 6 of the largest dominant nodes/masses; at least a 50% decrease in the SPD of hepatic and splenic nodules in their greatest transverse diameter; no increase in the size of the liver, spleen, and other nodes; no measurable disease in organs other than the liver or spleen; no new sites of disease; protocol-specified PET scan and bone marrow criteria.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable Analysis Set: treated participants with a baseline and \\>=1 post-baseline response evaluation (based on computed tomography/magnetic resonance imaging \\[CT/MRI\\] or positron emission tomography \\[PET\\] and clinical data), or who discontinued treatment due to progressive disease and had no major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendamustine and Rituximab (BR)', 'description': 'Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\\^2 IV on Day 1.'}, {'id': 'OG001', 'title': 'R-CHOP/R-CVP', 'description': 'Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.\n\nR-CHOP: rituximab 375 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\\^2 IV Day 1; cyclophosphamide 750 mg/m\\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5\n\nR-CVP: rituximab 375 mg/m\\^2 IV on Day 1; cyclophosphamide 750 mg/m\\^2 IV on Day 1 or cyclophosphamide 1000 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '221', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}]}, {'title': 'Severe AEs (grades 3, 4, 5)', 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related AEs', 'categories': [{'measurements': [{'value': '209', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'AE relationship was not assessed (not collected) for participants in the R-CHOP/R-CVP treatment group because it was open label and the events associated with R-CHOP/R-CVP arm were known due to being standard treatment for many countries.', 'groupId': 'OG001'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Withdrawn due to AEs', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '32 weeks', 'description': "AE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. An AE can, therefore, be any unfavorable and unintended physical sign, symptom, or laboratory parameter that develops or worsens in severity during the course of the study, or significant worsening of the disease under study (or any concurrent disease), whether or not considered related to the study drug. AEs were graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). SAE=an adverse event occurring at any dose that results in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity (a substantial disruption of one's ability to conduct normal life functions), a congenital anomaly/birth defect, or other important medical event.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen.'}, {'type': 'SECONDARY', 'title': 'Worst Overall Common Terminology Criteria for Adverse Events (CTCAE) Grades for Serum Chemistry Laboratory Test Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendamustine and Rituximab (BR)', 'description': 'Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\\^2 IV on Day 1.'}, {'id': 'OG001', 'title': 'R-CHOP/R-CVP', 'description': 'Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.\n\nR-CHOP: rituximab 375 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\\^2 IV Day 1; cyclophosphamide 750 mg/m\\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5\n\nR-CVP: rituximab 375 mg/m\\^2 IV on Day 1; cyclophosphamide 750 mg/m\\^2 IV on Day 1 or cyclophosphamide 1000 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5'}], 'classes': [{'title': 'Albumin: Grade 1', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Albumin: Grade 2', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Albumin: Grade 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Albumin: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Albumin: Grades 1-4', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase: Grade 1', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase: Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase: Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase: Grades 1-4', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine: Grade 1', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine: Grade 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine: Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine: Grades 1-4', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Gamma-glutamyl transferase: Grade 1', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Gamma-glutamyl transferase: Grade 2', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Gamma-glutamyl transferase: Grade 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Gamma-glutamyl transferase: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gamma-glutamyl transferase: Grades 1-4', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Hypercalcemia: Grade 1', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Hypercalcemia: Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypercalcemia: Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypercalcemia: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypercalcemia: Grades 1-4', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycemia: Grade 1', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycemia: Grade 2', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycemia: Grade 3', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycemia: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycemia: Grades 1-4', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia: Grade 1', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia: Grade 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia: Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia: Grades 1-4', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Hypernatremia: Grade 1', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Hypernatremia: Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypernatremia: Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypernatremia: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypernatremia: Grades 1-4', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Hypocalcemia: Grade 1', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Hypocalcemia: Grade 2', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Hypocalcemia: Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypocalcemia: Grade 4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypocalcemia: Grades 1-4', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia: Grade 1', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia: Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia: Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia: Grades 1-4', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia: Grade 1', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia: Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia: Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia: Grades 1-4', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia: Grade 1', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia: Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia: Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia: Grades 1-4', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Magnesium: Grade 1', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Magnesium: Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Magnesium: Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Magnesium: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Magnesium: Grades 1-4', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus: Grade 1', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus: Grade 2', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus: Grade 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus: Grades 1-4', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase: Grade 1', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase: Grade 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase: Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase: Grades 1-4', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase: Grade 1', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase: Grade 2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase: Grade 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase: Grades 1-4', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin: Grade 1', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin: Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin: Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin: Grades 1-4', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid: Grade 1', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid: Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid: Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid: Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid: Grades 1-4', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)', 'description': "Clinical laboratory data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for serum chemistry test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and laboratory test across all cycles).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and who had a post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Worst Overall CTCAE Grade for Hematology Laboratory Test Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendamustine and Rituximab (BR)', 'description': 'Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\\^2 IV on Day 1.'}, {'id': 'OG001', 'title': 'R-CHOP/R-CVP', 'description': 'Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.\n\nR-CHOP: rituximab 375 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\\^2 IV Day 1; cyclophosphamide 750 mg/m\\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5\n\nR-CVP: rituximab 375 mg/m\\^2 IV on Day 1; cyclophosphamide 750 mg/m\\^2 IV on Day 1 or cyclophosphamide 1000 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5'}], 'classes': [{'title': 'Absolute Neutrophil Count: Grade 1', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophil Count: Grade 2', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophil Count: Grade 3', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophil Count: Grade 4', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophil Count: Grades 1-4', 'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin: Grade 1', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin: Grade 2', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin: Grade 3', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin: Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin: Grades 1-4', 'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes Absolute: Grade 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes Absolute: Grade 2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes Absolute: Grade 3', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes Absolute: Grade 4', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes Absolute: Grades 1-4', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}]}, {'title': 'Platelets: Grade 1', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}, {'title': 'Platelets: Grade 2', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Platelets: Grade 3', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Platelets: Grade 4', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Platelets: Grades 1-4', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells: Grade 1', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells: Grade 2', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells: Grade 3', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells: Grade 4', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells: Grades 1-4', 'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '32 weeks (conducted at screening, Day 1 of each cycle, weekly during treatment, and at the end-of-treatment visit)', 'description': "Hematology test data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for hematology test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and hematology test across all cycles).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and who had an assessment.'}, {'type': 'SECONDARY', 'title': 'Clinically Significant Abnormal Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendamustine and Rituximab (BR)', 'description': 'Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\\^2 IV on Day 1.'}, {'id': 'OG001', 'title': 'R-CHOP/R-CVP', 'description': 'Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.\n\nR-CHOP: rituximab 375 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\\^2 IV Day 1; cyclophosphamide 750 mg/m\\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5\n\nR-CVP: rituximab 375 mg/m\\^2 IV on Day 1; cyclophosphamide 750 mg/m\\^2 IV on Day 1 or cyclophosphamide 1000 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5'}], 'classes': [{'title': 'Heart Rate >=120 and ↑ >=15 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Heart Rate <=50 and ↓ >=15 bpm', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Systolic Blood Pressure(BP) >=180 and ↑ >=20 mm Hg', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Systolic BP <=90 and ↓ >=20 mm Hg', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic BP >=105 and ↑ from Baseline >=15 mm Hg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic BP <=50 and ↓ from Baseline >=15 mm Hg', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and had baseline and post-baseline values.'}, {'type': 'SECONDARY', 'title': 'Potentially Clinically Significant Abnormal Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendamustine and Rituximab (BR)', 'description': 'Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\\^2 IV on Day 1.'}, {'id': 'OG001', 'title': 'R-CHOP/R-CVP', 'description': 'Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.\n\nR-CHOP: rituximab 375 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\\^2 IV Day 1; cyclophosphamide 750 mg/m\\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5\n\nR-CVP: rituximab 375 mg/m\\^2 IV on Day 1; cyclophosphamide 750 mg/m\\^2 IV on Day 1 or cyclophosphamide 1000 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5'}], 'classes': [{'title': 'Increase >=10%', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Decrease >=10%', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 32', 'description': 'Participants were weighed at Baseline and at Endpoint (Week 32); those participants with an increase or decrease of \\>=10% were considered potentially clinically significant.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen with a baseline and post-baseline weight.'}, {'type': 'SECONDARY', 'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status at the End of Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendamustine/Rituximab', 'description': 'bendamustine at 90 mg/m2 iv on days 1 and 2 and rituximab at 375 mg/m2 iv infusion on day 1'}, {'id': 'OG001', 'title': 'R-CHOP/R-CVP', 'description': 'R-CHOP, consisting of rituximab at 375 mg/m2 iv on day 1, vincristine at 1.4 mg /m2 (up to a maximum dose of 2 mg iv) by iv on day 1, prednisone at 100 mg orally on days 1 to 5 of a 21-day cycle, doxorubicin at 50 mg/m2 by iv over 3-5 minutes on day 1, cyclophosphamide iv at 750 mg/m2 on day 1.\n\nR-CVP consisting of rituximab at 375 mg/m2 iv on day 1, vincristine at 1.4 mg /m2 (up to a maximum dose of 2 mg iv) by iv on day 1, prednisone at 100 mg orally on days 1 to 5 of a 21-day cycle, only 1 of the following doses of cyclophosphamide throughout the study: cyclophosphamide at 750 mg/m2 iv on day 1 or cyclophosphamide at 1000 mg/m2 iv on day 1.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Stayed the Same', 'categories': [{'measurements': [{'value': '153', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 32', 'description': "Participants' ECOG Performance Status was evaluated at the end of treatment as improved, stayed the same, or worsened from baseline (see Baseline Characteristics for ECOG Performance Status).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and with baseline and post-baseline values.'}, {'type': 'SECONDARY', 'title': 'Therapeutic Classification of Prior Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendamustine and Rituximab (BR)', 'description': 'Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\\^2 IV on Day 1.'}, {'id': 'OG001', 'title': 'R-CHOP/R-CVP', 'description': 'Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.\n\nR-CHOP: rituximab 375 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\\^2 IV Day 1; cyclophosphamide 750 mg/m\\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5\n\nR-CVP: rituximab 375 mg/m\\^2 IV on Day 1; cyclophosphamide 750 mg/m\\^2 IV on Day 1 or cyclophosphamide 1000 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5'}], 'classes': [{'title': 'Psycholeptics', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Sex Hormones and Modulators of the Genital System', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Stomatological Preparations', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Throat Preparations', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Thyroid Therapy', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Topical Products for Join and Muscular Pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Unspecified Herbal', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Urologicals', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Vaccines', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Vasoprotectives', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vitamins', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'prior to start of treatment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants randomly assigned to a treatment group'}, {'type': 'SECONDARY', 'title': 'Therapeutic Classification of Concomitant Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendamustine and Rituximab (BR)', 'description': 'Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\\^2 IV on Day 1.'}, {'id': 'OG001', 'title': 'R-CHOP/R-CVP', 'description': 'Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.\n\nR-CHOP: rituximab 375 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\\^2 IV Day 1; cyclophosphamide 750 mg/m\\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5\n\nR-CVP: rituximab 375 mg/m\\^2 IV on Day 1; cyclophosphamide 750 mg/m\\^2 IV on Day 1 or cyclophosphamide 1000 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5'}], 'classes': [{'title': 'Psycholeptics', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'Sex Hormones and Modulators of the Genital System', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Stomatological Preparations', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Throat Preparations', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Thyroid Therapy', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Topical Preparations for Join and Muscular Pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Unspecified Herbal', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Urologicals', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Vaccines', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Vasoprotectives', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Vitamins', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '32 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Treatment in the Global Health Status Score of the European Organization for Research and Treatment of Cancer (EORTC) 30-item Core Quality of Life Questionnaire (QLQ-C30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendamustine and Rituximab (BR)', 'description': 'Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\\^2 IV on Day 1.'}, {'id': 'OG001', 'title': 'R-CHOP/R-CVP', 'description': 'Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.\n\nR-CHOP: rituximab 375 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\\^2 IV Day 1; cyclophosphamide 750 mg/m\\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5\n\nR-CVP: rituximab 375 mg/m\\^2 IV on Day 1; cyclophosphamide 750 mg/m\\^2 IV on Day 1 or cyclophosphamide 1000 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '24.60', 'groupId': 'OG000'}, {'value': '-5.1', 'spread': '24.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment group, region, preassigned standard treatment, and lymphoma type as factors and baseline value as the covariate.', 'groupDescription': 'The hypothesis of interest is superiority of BR over standard treatment.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (prior to treatment), 32 weeks', 'description': 'EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). This outcome reports the global health status on a scale of 0-100 with a high score for the global health status/QOL represents a high quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The set of randomized participants (intent-to-treat) consisting of all patients randomly assigned to treatment, and who had data at both timepoints.'}, {'type': 'SECONDARY', 'title': 'Participants With Disease Progression, Relapse or Death At the End of the Treatment Period or the Long-Term Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendamustine and Rituximab (BR)', 'description': 'Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\\^2 IV on Day 1.'}, {'id': 'OG001', 'title': 'R-CHOP/R-CVP', 'description': 'Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.\n\nR-CHOP: rituximab 375 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\\^2 IV Day 1; cyclophosphamide 750 mg/m\\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5\n\nR-CVP: rituximab 375 mg/m\\^2 IV on Day 1; cyclophosphamide 750 mg/m\\^2 IV on Day 1 or cyclophosphamide 1000 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9677', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.58', 'ciUpperLimit': '1.68', 'estimateComment': 'BR/RCHOP-RCVP', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified log-rank test by preassigned standard treatment and lymphoma type.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period', 'description': 'Relapsed disease (after CR) and progressive disease (PD) (after PR or SD):\n\n* Lymph nodes were considered abnormal if the long axis was greater than 1.5 cm. Lymph nodes with a long axis of 1.1 to 1.5 cm were considered abnormal if its short axis was greater than 1.0 cm.\n* In patients with no prior history of pulmonary lymphoma, new lung nodules identified by CT require histologic confirmation.\n* \\>= 50% increase from nadir in sum of the products of the greatest diameters (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules). To be considered progressive disease, a lymph node with a diameter of the short axis of less than 1.0 cm must have increased by 2: 50% and to a size of 1.5 cm by 1.5 cm, or more than 1.5 cm in the long axis\n* other conditions as specified in the protocol', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized patients: the set of randomized patients (intent-to-treat) consists of all patients randomly assigned to treatment.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate for Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendamustine and Rituximab (BR)', 'description': 'Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\\^2 IV on Day 1.'}, {'id': 'OG001', 'title': 'R-CHOP/R-CVP', 'description': 'Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.\n\nR-CHOP: rituximab 375 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\\^2 IV Day 1; cyclophosphamide 750 mg/m\\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5\n\nR-CVP: rituximab 375 mg/m\\^2 IV on Day 1; cyclophosphamide 750 mg/m\\^2 IV on Day 1 or cyclophosphamide 1000 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5'}], 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000', 'lowerLimit': '16.9', 'upperLimit': '43.2'}, {'value': '33.4', 'groupId': 'OG001', 'lowerLimit': '19.3', 'upperLimit': '48.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)', 'description': 'PFS was defined as the time from randomization to disease progression or relapse, or death from any cause, whichever occurred first.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized patients'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate for Event-free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendamustine and Rituximab (BR)', 'description': 'Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\\^2 IV on Day 1.'}, {'id': 'OG001', 'title': 'R-CHOP/R-CVP', 'description': 'Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.\n\nR-CHOP: rituximab 375 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\\^2 IV Day 1; cyclophosphamide 750 mg/m\\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5\n\nR-CVP: rituximab 375 mg/m\\^2 IV on Day 1; cyclophosphamide 750 mg/m\\^2 IV on Day 1 or cyclophosphamide 1000 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5'}], 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000', 'lowerLimit': '15.5', 'upperLimit': '43.2'}, {'value': '32.6', 'groupId': 'OG001', 'lowerLimit': '18.1', 'upperLimit': '44.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)', 'description': 'EFS was defined as the time from randomization to treatment failure, disease progression or relapse, other malignancies, or death from any cause, whichever occurred first.\n\nTreatment failure was defined as failure to achieve a CR or PR after 6 cycles of treatment. If a patient failed to achieve CR or PR by the time of data analysis or early withdrawal, the treatment failure date was set at 126 days (6 cycles of treatment) after randomization or the new anticancer treatment date, whichever is earlier.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized patients'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate for Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendamustine and Rituximab (BR)', 'description': 'Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\\^2 IV on Day 1.'}, {'id': 'OG001', 'title': 'R-CHOP/R-CVP', 'description': 'Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.\n\nR-CHOP: rituximab 375 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\\^2 IV Day 1; cyclophosphamide 750 mg/m\\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5\n\nR-CVP: rituximab 375 mg/m\\^2 IV on Day 1; cyclophosphamide 750 mg/m\\^2 IV on Day 1 or cyclophosphamide 1000 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5'}], 'classes': [{'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000', 'lowerLimit': '12.8', 'upperLimit': '42.9'}, {'value': '32.1', 'groupId': 'OG001', 'lowerLimit': '19.8', 'upperLimit': '46.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)', 'description': 'DOR was defined as the time from first response (CR or PR) to disease progression or relapse, or death due to any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized patients with complete response (CR) or partial response (PR)'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendamustine and Rituximab (BR)', 'description': 'Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\\^2 IV on Day 1.'}, {'id': 'OG001', 'title': 'R-CHOP/R-CVP', 'description': 'Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.\n\nR-CHOP: rituximab 375 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\\^2 IV Day 1; cyclophosphamide 750 mg/m\\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5\n\nR-CVP: rituximab 375 mg/m\\^2 IV on Day 1; cyclophosphamide 750 mg/m\\^2 IV on Day 1 or cyclophosphamide 1000 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5'}], 'classes': [{'categories': [{'measurements': [{'value': '65.0', 'groupId': 'OG000', 'lowerLimit': '64.8', 'upperLimit': '65.1'}, {'value': '64.1', 'groupId': 'OG001', 'lowerLimit': '63.8', 'upperLimit': '64.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)', 'description': 'OS was defined as the time from randomization to death from any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized patients'}, {'type': 'SECONDARY', 'title': 'Participants Who Died At the End of the Treatment Period or the Long-Term Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendamustine and Rituximab (BR)', 'description': 'Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\\^2 IV on Day 1.'}, {'id': 'OG001', 'title': 'R-CHOP/R-CVP', 'description': 'Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.\n\nR-CHOP: rituximab 375 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\\^2 IV Day 1; cyclophosphamide 750 mg/m\\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5\n\nR-CVP: rituximab 375 mg/m\\^2 IV on Day 1; cyclophosphamide 750 mg/m\\^2 IV on Day 1 or cyclophosphamide 1000 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5'}], 'classes': [{'title': 'All Deaths', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Deaths within 30 days of study treatment', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Deaths greater than 30 days of study treatment', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period', 'description': 'Death is due to any cause. Data are broken out by patients who died within 30 days of the last dose of study medications, and those who died greater than 30 days of the last dose of study medications.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized patients: the set of randomized patients (intent-to-treat) consists of all patients randomly assigned to treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bendamustine and Rituximab (BR)', 'description': 'Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\\^2 IV on Day 1.'}, {'id': 'FG001', 'title': 'R-CHOP/R-CVP', 'description': 'Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.\n\nR-CHOP: rituximab 375 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\\^2 IV Day 1; cyclophosphamide 750 mg/m\\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5\n\nR-CVP: rituximab 375 mg/m\\^2 IV on Day 1; cyclophosphamide 750 mg/m\\^2 IV on Day 1 or cyclophosphamide 1000 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '224'}, {'groupId': 'FG001', 'numSubjects': '223'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '199'}, {'groupId': 'FG001', 'numSubjects': '196'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Started New Treatment Regimen', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Randomized but Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}, {'title': 'Long-Term Follow-up Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '210'}, {'groupId': 'FG001', 'numSubjects': '209'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '157'}, {'groupId': 'FG001', 'numSubjects': '154'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '55'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'preAssignmentDetails': 'A total of 568 participants were screened, and 121 were not randomized (2 due to adverse event, 14 withdrew consent, 68 did not meet inclusion criteria, 23 met exclusion criteria, and 14 for other reasons).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '447', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bendamustine and Rituximab (BR)', 'description': 'Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\\^2 IV on Day 1.'}, {'id': 'BG001', 'title': 'R-CHOP/R-CVP', 'description': 'Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.\n\nR-CHOP: rituximab 375 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\\^2 IV Day 1; cyclophosphamide 750 mg/m\\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5\n\nR-CVP: rituximab 375 mg/m\\^2 IV on Day 1; cyclophosphamide 750 mg/m\\^2 IV on Day 1 or cyclophosphamide 1000 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'spread': '11.37', 'groupId': 'BG000'}, {'value': '58.2', 'spread': '12.11', 'groupId': 'BG001'}, {'value': '59.1', 'spread': '11.77', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'European Cooperative Oncology Group Performance Status', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'ECOG criteria: 0: Fully active. 1: Ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of all selfcare. 3: Capable of limited selfcare, confined to bed or chair more than 50% of waking hours. 4: Completely disabled, no selfcare, totally confined to bed or chair. 5: Dead. 1 participant in the R-CHOP/R-CVP treatment group did not have an assessment at baseline.', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '81.9', 'spread': '18.48', 'groupId': 'BG000'}, {'value': '82.4', 'spread': '17.93', 'groupId': 'BG001'}, {'value': '82.1', 'spread': '18.19', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'one participant in the R-CHOP/R-CVP group did not a a weight measurement at baseline', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 447}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04-30'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'dispFirstSubmitDate': '2013-08-08', 'completionDateStruct': {'date': '2012-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-08', 'studyFirstSubmitDate': '2009-04-03', 'dispFirstSubmitQcDate': '2013-08-08', 'resultsFirstSubmitDate': '2014-03-25', 'studyFirstSubmitQcDate': '2009-04-06', 'dispFirstPostDateStruct': {'date': '2013-08-20', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-03-25', 'studyFirstPostDateStruct': {'date': '2009-04-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Complete Response (CR) at End of Treatment Period', 'timeFrame': '6 to 8 21 or 28-day cycles (18-32 weeks)', 'description': 'CR=complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present pretherapy; protocol-specified positron emission tomography (PET) scan assessment criteria; (if the spleen and/or liver were enlarged on the basis of physical examination and/or anatomic imaging before treatment) the liver and/or spleen were considered normal size on physical examination and by anatomic imaging after therapy, with disappearance of all nodules related to lymphoma; (if the bone marrow was involved by lymphoma before treatment) the infiltrate must have cleared on subsequent bone marrow biopsies.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Overall Response at End of Treatment Period', 'timeFrame': '6 to 8 21 or 28-day cycles (18-32 weeks)', 'description': 'Overall Response=participants with Complete Remission (CR) + those with Partial Remission (PR). CR=see Outcome Measure 1 for details. PR= at least a 50% decrease in the sum of the product of the greatest diameters (SPD) of up to 6 of the largest dominant nodes/masses; at least a 50% decrease in the SPD of hepatic and splenic nodules in their greatest transverse diameter; no increase in the size of the liver, spleen, and other nodes; no measurable disease in organs other than the liver or spleen; no new sites of disease; protocol-specified PET scan and bone marrow criteria.'}, {'measure': 'Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period', 'timeFrame': '32 weeks', 'description': "AE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. An AE can, therefore, be any unfavorable and unintended physical sign, symptom, or laboratory parameter that develops or worsens in severity during the course of the study, or significant worsening of the disease under study (or any concurrent disease), whether or not considered related to the study drug. AEs were graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). SAE=an adverse event occurring at any dose that results in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity (a substantial disruption of one's ability to conduct normal life functions), a congenital anomaly/birth defect, or other important medical event."}, {'measure': 'Worst Overall Common Terminology Criteria for Adverse Events (CTCAE) Grades for Serum Chemistry Laboratory Test Results', 'timeFrame': '32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)', 'description': "Clinical laboratory data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for serum chemistry test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and laboratory test across all cycles)."}, {'measure': 'Worst Overall CTCAE Grade for Hematology Laboratory Test Results', 'timeFrame': '32 weeks (conducted at screening, Day 1 of each cycle, weekly during treatment, and at the end-of-treatment visit)', 'description': "Hematology test data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for hematology test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and hematology test across all cycles)."}, {'measure': 'Clinically Significant Abnormal Vital Signs', 'timeFrame': '32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)'}, {'measure': 'Potentially Clinically Significant Abnormal Weight', 'timeFrame': 'Baseline, Week 32', 'description': 'Participants were weighed at Baseline and at Endpoint (Week 32); those participants with an increase or decrease of \\>=10% were considered potentially clinically significant.'}, {'measure': 'Eastern Cooperative Oncology Group (ECOG) Performance Status at the End of Treatment Period', 'timeFrame': 'Week 32', 'description': "Participants' ECOG Performance Status was evaluated at the end of treatment as improved, stayed the same, or worsened from baseline (see Baseline Characteristics for ECOG Performance Status)."}, {'measure': 'Therapeutic Classification of Prior Medications', 'timeFrame': 'prior to start of treatment'}, {'measure': 'Therapeutic Classification of Concomitant Medications', 'timeFrame': '32 weeks'}, {'measure': 'Change From Baseline to End of Treatment in the Global Health Status Score of the European Organization for Research and Treatment of Cancer (EORTC) 30-item Core Quality of Life Questionnaire (QLQ-C30)', 'timeFrame': 'Day 1 (prior to treatment), 32 weeks', 'description': 'EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). This outcome reports the global health status on a scale of 0-100 with a high score for the global health status/QOL represents a high quality of life.'}, {'measure': 'Participants With Disease Progression, Relapse or Death At the End of the Treatment Period or the Long-Term Follow-up Period', 'timeFrame': 'Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period', 'description': 'Relapsed disease (after CR) and progressive disease (PD) (after PR or SD):\n\n* Lymph nodes were considered abnormal if the long axis was greater than 1.5 cm. Lymph nodes with a long axis of 1.1 to 1.5 cm were considered abnormal if its short axis was greater than 1.0 cm.\n* In patients with no prior history of pulmonary lymphoma, new lung nodules identified by CT require histologic confirmation.\n* \\>= 50% increase from nadir in sum of the products of the greatest diameters (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules). To be considered progressive disease, a lymph node with a diameter of the short axis of less than 1.0 cm must have increased by 2: 50% and to a size of 1.5 cm by 1.5 cm, or more than 1.5 cm in the long axis\n* other conditions as specified in the protocol'}, {'measure': 'Kaplan-Meier Estimate for Progression-free Survival (PFS)', 'timeFrame': 'Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)', 'description': 'PFS was defined as the time from randomization to disease progression or relapse, or death from any cause, whichever occurred first.'}, {'measure': 'Kaplan-Meier Estimate for Event-free Survival (EFS)', 'timeFrame': 'Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)', 'description': 'EFS was defined as the time from randomization to treatment failure, disease progression or relapse, other malignancies, or death from any cause, whichever occurred first.\n\nTreatment failure was defined as failure to achieve a CR or PR after 6 cycles of treatment. If a patient failed to achieve CR or PR by the time of data analysis or early withdrawal, the treatment failure date was set at 126 days (6 cycles of treatment) after randomization or the new anticancer treatment date, whichever is earlier.'}, {'measure': 'Kaplan-Meier Estimate for Duration of Response (DOR)', 'timeFrame': 'Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)', 'description': 'DOR was defined as the time from first response (CR or PR) to disease progression or relapse, or death due to any cause.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)', 'description': 'OS was defined as the time from randomization to death from any cause.'}, {'measure': 'Participants Who Died At the End of the Treatment Period or the Long-Term Follow-up Period', 'timeFrame': 'Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period', 'description': 'Death is due to any cause. Data are broken out by patients who died within 30 days of the last dose of study medications, and those who died greater than 30 days of the last dose of study medications.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Non-Hodgkin's Lymphoma", 'Mantle Cell Lymphoma']}, 'referencesModule': {'references': [{'pmid': '24591201', 'type': 'RESULT', 'citation': 'Flinn IW, van der Jagt R, Kahl BS, Wood P, Hawkins TE, Macdonald D, Hertzberg M, Kwan YL, Simpson D, Craig M, Kolibaba K, Issa S, Clementi R, Hallman DM, Munteanu M, Chen L, Burke JM. Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study. Blood. 2014 May 8;123(19):2944-52. doi: 10.1182/blood-2013-11-531327. Epub 2014 Mar 3.'}, {'pmid': '30811293', 'type': 'DERIVED', 'citation': 'Flinn IW, van der Jagt R, Kahl B, Wood P, Hawkins T, MacDonald D, Simpson D, Kolibaba K, Issa S, Chang J, Trotman J, Hallman D, Chen L, Burke JM. First-Line Treatment of Patients With Indolent Non-Hodgkin Lymphoma or Mantle-Cell Lymphoma With Bendamustine Plus Rituximab Versus R-CHOP or R-CVP: Results of the BRIGHT 5-Year Follow-Up Study. J Clin Oncol. 2019 Apr 20;37(12):984-991. doi: 10.1200/JCO.18.00605. Epub 2019 Feb 27.'}, {'pmid': '26875824', 'type': 'DERIVED', 'citation': 'Burke JM, van der Jagt RH, Kahl BS, Wood P, Hawkins TE, MacDonald D, Hertzberg M, Simpson D, Craig M, Kolibaba K, Issa S, Munteanu M, Victor TW, Flinn IW. Differences in Quality of Life Between Bendamustine-Rituximab and R-CHOP/R-CVP in Patients With Previously Untreated Advanced Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma. Clin Lymphoma Myeloma Leuk. 2016 Apr;16(4):182-190.e1. doi: 10.1016/j.clml.2016.01.001. Epub 2016 Jan 15.'}]}, 'descriptionModule': {'briefSummary': "The primary objective of the study is to compare the complete response (CR) rate of bendamustine and rituximab (BR) with that of standard treatment regimens of either rituximab, cyclophosphamide, vincristine, and prednisone (R-CVP) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with advanced, indolent non-Hodgkin's lymphoma (NHL) or mantle cell lymphoma (MCL)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Histopathologic confirmation of one of the following cluster of differentiation antigen 20 positive (CD20+) B-cell non-Hodgkin\'s lymphomas (tissue diagnostic procedures must be performed within 6 months of study entry and with biopsy material available for review):\n\n * follicular lymphoma (NCI CTCAE grade 1 or 2)\n * immunoplasmacytoma/immunocytoma (Waldenstrom\'s macroglobulinemia)\n * splenic marginal zone B-cell lymphoma\n * extra-nodal marginal zone lymphoma of mucosa-associated lymphoid tumor (MALT) type\n * nodal marginal zone B-cell lymphoma\n * mantle cell lymphoma\n* Meets one of the following need-for-treatment criteria (with the exception of mantle cell lymphoma for which treatment is indicated):\n\n * presence of at least one of the following B-symptoms:\n\n 1. fever (\\>38ºC) of unclear etiology\n 2. night sweats\n 3. weight loss of greater than 10% within the prior 6 months\n * large tumor mass (bulky disease)\n * presence of lymphoma-related complications, including narrowing of ureters or bile ducts, tumor-related compression of a vital organ, lymphoma-induced pain, cytopenias related to lymphoma/leukemia, splenomegaly, pleural effusions, or ascites\n * hyperviscosity syndrome due to monoclonal gammopathy\n* CD20+ B cells in lymph node biopsy or other lymphoma pathology specimen.\n* No prior treatment (patients on "watch and wait" may enter the study if a recent biopsy \\[obtained within the last 6 months\\] is available)\n* Adequate hematologic function (unless abnormalities related to lymphoma infiltration of the bone marrow or hypersplenism due to lymphoma) as follows:\n\n * hemoglobin of \\>= 10.0 g/dL\n * absolute neutrophil count (ANC) \\>=1.5\\*10\\^9/L\n * platelet count \\>=100\\*10\\^9/L\n* Bidimensionally measurable disease (field not previously radiated)\n* Able to provide written informed consent\n* Eastern Cooperative Oncology Group (ECOG) Performance Status \\<=2\n* Estimated life expectancy \\>=6 months\n* Serum creatinine of \\<=2.0 mg/dL or creatinine clearance \\>=50 mL/min\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤2.5\\*upper limit of normal (ULN), and alkaline phosphatase and total bilirubin within normal limits\n* Left ventricular ejection fraction (LVEF) \\>= 50% by multiple gated acquisition scan (MUGA) or cardiac echocardiogram (ECHO), prior for any patient to be treated with R-CHOP\n* A medically accepted method of contraception to be used by women of childbearing potential (not surgically sterile or at least 12 months naturally postmenopausal)\n* Men capable of producing offspring and not surgically sterile must practice abstinence or use a barrier method of birth control.\n\nKey Exclusion Criteria:\n\n* Chronic lymphocytic leukemia, small lymphocytic lymphoma (SLL), or grade 3 follicular lymphoma\n* Transformed disease (bone marrow blasts are permitted; however, transformed disease indicating leukemic involvement is not permitted)\n* Central nervous system (CNS) lymphomatous involvement or leptomeningeal lymphoma\n* Prior radiation for NHL, except for a single course of locally delimited radiation therapy with a radiation field not exceeding 2 adjacent lymph node regions\n* Active malignancy, other than NHL, within the past 3 years except for localized prostate cancer treated with hormone therapy, cervical carcinoma in situ, breast cancer in situ, or non-melanoma skin cancer following definitive treatment\n* New York Heart Association (NYHA) Class III or IV heart failure, arrhythmias or unstable angina, electrocardiograph (ECG) evidence of active ischemia or active conduction system abnormalities, or myocardial infarction within the last 6 months (prior to study entry, ECG abnormalities at screening must be documented by the investigator as not medically relevant)\n* Known human immunodeficiency virus (HIV) positivity\n* Active hepatitis B or hepatitis C infection (hepatitis B surface antigen testing required)\n* Women who are pregnant or lactating\n* Corticosteroids for treatment of lymphoma within 28 days of study entry Chronically administered low-dose corticosteroids (e.g., prednisone ≤20 mg/day) for indications other than lymphoma or lymphoma-related complications are permitted\n* Any serious uncontrolled, medical or psychological disorder that would impair the ability of the patient to receive therapy\n* Any condition which places the patient at unacceptable risk or confounds the ability of the investigators to interpret study data\n* Any other investigational agent within 28 days of study entry\n* Known hypersensitivity to bendamustine, mannitol, or other study-related drugs\n* Ann Arbor stage I disease.'}, 'identificationModule': {'nctId': 'NCT00877006', 'briefTitle': "Study of Bendamustine Hydrochloride and Rituximab (BR) Compared With R-CVP or R-CHOP in the First-Line Treatment of Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL) - Referred to as the BRIGHT Study", 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': "An Open-Label, Randomized, Parallel-Group Study of Bendamustine Hydrochloride and Rituximab (BR) Compared With Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in the First-Line Treatment of Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL)", 'orgStudyIdInfo': {'id': 'C18083/3064/NL/MN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bendamustine and Rituximab (BR)', 'description': 'Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\\^2 IV on Day 1', 'interventionNames': ['Drug: bendamustine', 'Drug: rituximab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'R-CHOP/R-CVP', 'description': 'Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.\n\nR-CHOP: rituximab 375 mg/m\\^2 IV on Day 1; vincristine 1.4 mg/m\\^2 (up to 2 mg/m\\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\\^2 IV Day 1; cyclophosphamide 750 mg/m\\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 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