Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT00281918
Status:
COMPLETED
Last Update Posted:
2013-09-19
First Post:
2006-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C042382', 'term': 'fludarabine phosphate'}], 'ancestors': [{'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': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-LaRoche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were recorded until 28 days after completion of study treatment (median time approximately 21 months). Serious Adverse Events reported until 1 year post-treatment or initiation of new CLL treatment (median time approximately 42 months).', 'description': 'The safety population included all participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Fludarabine+Cyclophosphamide (FC)', 'description': 'Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.', 'otherNumAtRisk': 398, 'otherNumAffected': 122, 'seriousNumAtRisk': 398, 'seriousNumAffected': 164}, {'id': 'EG001', 'title': 'Fludarabine+Cyclophosphamide+Rituximab (FCR)', 'description': 'Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.', 'otherNumAtRisk': 402, 'otherNumAffected': 185, 'seriousNumAtRisk': 402, 'seriousNumAffected': 186}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 116}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 88}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hepatitis B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pneumocystis Jiroveci Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pneumocystis Jiroveci Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pneumonia Primary Atypical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Cerebral Toxoplasmosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Neutropenic Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Oral Herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pneumonia Fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Chronic Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Cytomegalovirus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Enterococcal Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Gastroenteritis Cryptosporidial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hepatitis C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hepatobiliary Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Herpes Simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Herpes Virus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Herpes Zoster Ophthalmic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Infected Skin Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Lower Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Lung Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Lung Infection Pseudomonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Neutropenic Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Oesophageal Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Orchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Periorbital Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pneumonia Respiratory Syncytial Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pseudomonal Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Skin Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Staphylococcal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Subcutaneous Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 31}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Haemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Febrile Bone Marrow Aplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Granulocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Haemolytic Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Agranulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, 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398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Calculus Ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Cystitis Haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Urinary Tract Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Renal Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Circulatory Collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Vasculitis Necrotising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Venous Thrombosis Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Infectious pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Anogenital warts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Endophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '407', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fludarabine+Cyclophosphamide (FC)', 'description': 'Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.'}, {'id': 'OG001', 'title': 'Fludarabine+Cyclophosphamide+Rituximab (FCR)', 'description': 'Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '981.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1343'}, {'value': '1212.0', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '1372'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Median observation time at time of analysis was approximately 21 months', 'description': 'Progression-free survival (PFS) was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.'}, {'type': 'SECONDARY', 'title': 'Event-free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '407', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fludarabine+Cyclophosphamide (FC)', 'description': 'Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.'}, {'id': 'OG001', 'title': 'Fludarabine+Cyclophosphamide+Rituximab (FCR)', 'description': 'Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '947.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1343'}, {'value': '1212.0', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '1372'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Median observation time at time of analysis was approximately 21 months', 'description': 'Event-free survival (EFS) was defined as the time between randomization and the date of disease progression, relapse, start of new CLL treatment or death by any cause.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '407', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fludarabine+Cyclophosphamide (FC)', 'description': 'Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.'}, {'id': 'OG001', 'title': 'Fludarabine+Cyclophosphamide+Rituximab (FCR)', 'description': 'Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.'}], 'classes': [{'title': 'Minimum number of days to an event', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '83', 'upperLimit': '90'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '89', 'upperLimit': '95'}]}]}, {'title': 'Maximum number of days to an event', 'categories': [{'measurements': [{'value': '1373', 'groupId': 'OG000'}, {'value': '1372', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0427', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Median observation time at time of analysis was approximately 21 months', 'description': 'Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. Median OS was not reached.', 'unitOfMeasure': 'Days', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.'}, {'type': 'SECONDARY', 'title': 'Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '407', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fludarabine+Cyclophosphamide (FC)', 'description': 'Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.'}, {'id': 'OG001', 'title': 'Fludarabine+Cyclophosphamide+Rituximab (FCR)', 'description': 'Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.'}], 'classes': [{'title': 'Minimum number of days to an event', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '91', 'groupId': 'OG001', 'lowerLimit': '939', 'upperLimit': '9999'}]}]}, {'title': 'Maximum number of days to an event', 'categories': [{'measurements': [{'value': '1164', 'groupId': 'OG000'}, {'value': '1226', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7882', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Median observation time at time of analysis was approximately 21 months', 'description': 'CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death. Median DFS was not reached.', 'unitOfMeasure': 'Days to an event', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.'}, {'type': 'PRIMARY', 'title': 'Final Analysis: Time to Progression-free Survival Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fludarabine+Cyclophosphamide (FC)', 'description': 'Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.'}, {'id': 'OG001', 'title': 'Fludarabine+Cyclophosphamide+Rituximab (FCR)', 'description': 'Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '998.0', 'groupId': 'OG000', 'lowerLimit': '886', 'upperLimit': '1129'}, {'value': '1703.0', 'groupId': 'OG001', 'lowerLimit': '1543', 'upperLimit': '1853'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.57', 'ciLowerLimit': '0.48', 'ciUpperLimit': '0.67', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Median observation time was approximately 66.4 months', 'description': 'Progression-free survival was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, that included all randomized participants, with PFS events.'}, {'type': 'SECONDARY', 'title': 'Final Analysis: Time to Overall Survival Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fludarabine+Cyclophosphamide (FC)', 'description': 'Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.'}, {'id': 'OG001', 'title': 'Fludarabine+Cyclophosphamide+Rituximab (FCR)', 'description': 'Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '2613.0', 'comment': 'Upper limit of the 95% confidence interval has not been reached.', 'groupId': 'OG000', 'lowerLimit': '2354', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median time to event and upper limit of the 95% confidence have not been reached.', 'groupId': 'OG001', 'lowerLimit': '2745', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.54', 'ciUpperLimit': '0.86', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Median observation time was approximately 66.4 months', 'description': 'Overall survival (OS) was defined as the time between randomization and the date of death due to any cause.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, that included all randomized participants who died.'}, {'type': 'SECONDARY', 'title': 'Final Analysis: Time to Event-free Survival Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fludarabine+Cyclophosphamide (FC)', 'description': 'Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.'}, {'id': 'OG001', 'title': 'Fludarabine+Cyclophosphamide+Rituximab (FCR)', 'description': 'Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '951.0', 'groupId': 'OG000', 'lowerLimit': '843', 'upperLimit': '1039'}, {'value': '1666.0', 'groupId': 'OG001', 'lowerLimit': '1415', 'upperLimit': '1799'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.57', 'ciLowerLimit': '0.48', 'ciUpperLimit': '0.67', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Median observation time was approximately 66.4 months', 'description': 'Event-free survival was defined as the time between randomization and the date of disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death by any cause.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, that included all randomized participants, with disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death.'}, {'type': 'SECONDARY', 'title': 'Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fludarabine+Cyclophosphamide (FC)', 'description': 'Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.'}, {'id': 'OG001', 'title': 'Fludarabine+Cyclophosphamide+Rituximab (FCR)', 'description': 'Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '1488.0', 'groupId': 'OG000', 'lowerLimit': '1198', 'upperLimit': '1836'}, {'value': '1854.0', 'groupId': 'OG001', 'lowerLimit': '1646', 'upperLimit': '2208'}]}]}], 'analyses': [{'pValue': '0.0523', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.52', 'ciUpperLimit': '1.02', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Median observation time was approximately 66.4 months', 'description': 'CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with complete response who experienced a disease free survival event (disease relapse or death).'}, {'type': 'SECONDARY', 'title': 'Final Analysis: Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fludarabine+Cyclophosphamide (FC)', 'description': 'Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.'}, {'id': 'OG001', 'title': 'Fludarabine+Cyclophosphamide+Rituximab (FCR)', 'description': 'Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '1102.0', 'groupId': 'OG000', 'lowerLimit': '977', 'upperLimit': '1249'}, {'value': '1718.0', 'groupId': 'OG001', 'lowerLimit': '1618', 'upperLimit': '1859'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.48', 'ciUpperLimit': '0.71', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Median observation time was approximately 66.4 months', 'description': 'Duration of response was defined as the time from the first documented Complete Response, Partial Response to disease progression or death by any cause.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with complete response or partial response who experienced an event (disease progression or death due to any cause).'}, {'type': 'SECONDARY', 'title': 'Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}, {'value': '408', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fludarabine+Cyclophosphamide (FC)', 'description': 'Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.'}, {'id': 'OG001', 'title': 'Fludarabine+Cyclophosphamide+Rituximab (FCR)', 'description': 'Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.4', 'groupId': 'OG000', 'lowerLimit': '67.8', 'upperLimit': '76.7'}, {'value': '85.8', 'groupId': 'OG001', 'lowerLimit': '82.0', 'upperLimit': '89.0'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.30', 'ciLowerLimit': '1.62', 'ciUpperLimit': '3.28', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Median observation time was approximately 66.4 months', 'description': 'CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fludarabine+Cyclophosphamide (FC)', 'description': 'Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.'}, {'id': 'OG001', 'title': 'Fludarabine+Cyclophosphamide+Rituximab (FCR)', 'description': 'Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '1455.0', 'groupId': 'OG000', 'lowerLimit': '1324', 'upperLimit': '1577'}, {'value': '2082.0', 'groupId': 'OG001', 'lowerLimit': '1926', 'upperLimit': '2253'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.72', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Median observation time was approximately 66.4 months', 'description': 'The time from randomization to the start of a new treatment.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, that included all randomized participants, who started a new CLL treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fludarabine+Cyclophosphamide (FC)', 'description': 'Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.'}, {'id': 'FG001', 'title': 'Fludarabine+Cyclophosphamide+Rituximab (FCR)', 'description': 'Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Informed consent unavailable for 2 patients at time of analysis; intent-to-treat population was 407.', 'groupId': 'FG000', 'numSubjects': '409'}, {'comment': 'Informed consent unavailable for 5 patients at time of analysis; intent-to-treat population was 403.', 'groupId': 'FG001', 'numSubjects': '408'}]}, {'type': 'Safety Population; Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '398'}, {'groupId': 'FG001', 'numSubjects': '402'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed all 6 cycles of study medication.', 'groupId': 'FG000', 'numSubjects': '267'}, {'comment': 'Completed all 6 cycles of study medication.', 'groupId': 'FG001', 'numSubjects': '300'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '108'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '407', 'groupId': 'BG000'}, {'value': '403', 'groupId': 'BG001'}, {'value': '810', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fludarabine+Cyclophosphamide (FC)', 'description': 'Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.'}, {'id': 'BG001', 'title': 'Fludarabine+Cyclophosphamide+Rituximab (FCR)', 'description': 'Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.3', 'spread': '8.55', 'groupId': 'BG000'}, {'value': '59.6', 'spread': '8.70', 'groupId': 'BG001'}, {'value': '59.5', 'spread': '8.62', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '302', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '600', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 817}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-09', 'studyFirstSubmitDate': '2006-01-24', 'resultsFirstSubmitDate': '2009-12-21', 'studyFirstSubmitQcDate': '2006-01-24', 'lastUpdatePostDateStruct': {'date': '2013-09-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-03', 'studyFirstPostDateStruct': {'date': '2006-01-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Median observation time at time of analysis was approximately 21 months', 'description': 'Progression-free survival (PFS) was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.'}, {'measure': 'Final Analysis: Time to Progression-free Survival Event', 'timeFrame': 'Median observation time was approximately 66.4 months', 'description': 'Progression-free survival was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.'}], 'secondaryOutcomes': [{'measure': 'Event-free Survival (EFS)', 'timeFrame': 'Median observation time at time of analysis was approximately 21 months', 'description': 'Event-free survival (EFS) was defined as the time between randomization and the date of disease progression, relapse, start of new CLL treatment or death by any cause.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Median observation time at time of analysis was approximately 21 months', 'description': 'Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. Median OS was not reached.'}, {'measure': 'Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR).', 'timeFrame': 'Median observation time at time of analysis was approximately 21 months', 'description': 'CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death. Median DFS was not reached.'}, {'measure': 'Final Analysis: Time to Overall Survival Event', 'timeFrame': 'Median observation time was approximately 66.4 months', 'description': 'Overall survival (OS) was defined as the time between randomization and the date of death due to any cause.'}, {'measure': 'Final Analysis: Time to Event-free Survival Event', 'timeFrame': 'Median observation time was approximately 66.4 months', 'description': 'Event-free survival was defined as the time between randomization and the date of disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death by any cause.'}, {'measure': 'Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR)', 'timeFrame': 'Median observation time was approximately 66.4 months', 'description': 'CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death'}, {'measure': 'Final Analysis: Duration of Response', 'timeFrame': 'Median observation time was approximately 66.4 months', 'description': 'Duration of response was defined as the time from the first documented Complete Response, Partial Response to disease progression or death by any cause.'}, {'measure': 'Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response', 'timeFrame': 'Median observation time was approximately 66.4 months', 'description': 'CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.'}, {'measure': 'Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL)', 'timeFrame': 'Median observation time was approximately 66.4 months', 'description': 'The time from randomization to the start of a new treatment.'}]}, 'conditionsModule': {'keywords': ['B-cell chronic lymphocytic leukemia', 'stage I chronic lymphocytic leukemia', 'stage II chronic lymphocytic leukemia', 'stage III chronic lymphocytic leukemia', 'stage IV chronic lymphocytic leukemia'], 'conditions': ['Leukemia']}, 'referencesModule': {'references': [{'pmid': '38620092', 'type': 'DERIVED', 'citation': 'Langerbeins P, Giza A, Robrecht S, Cramer P, von Tresckow J, Al-Sawaf O, Fink AM, Furstenau M, Kutsch N, Simon F, Goede V, Hoechstetter M, Niemann CU, da Cunha-Bang C, Kater A, Dubois J, Gregor M, Staber PB, Tausch E, Schneider C, Stilgenbauer S, Eichhorst B, Fischer K, Hallek M. Reassessing the chronic lymphocytic leukemia International Prognostic Index in the era of targeted therapies. Blood. 2024 Jun 20;143(25):2588-2598. doi: 10.1182/blood.2023022564.'}, {'pmid': '33730841', 'type': 'DERIVED', 'citation': 'Bloehdorn J, Krzykalla J, Holzmann K, Gerhardinger A, Jebaraj BMC, Bahlo J, Humphrey K, Tausch E, Robrecht S, Mertens D, Schneider C, Fischer K, Hallek M, Dohner H, Benner A, Stilgenbauer S. Integrative prognostic models predict long-term survival after immunochemotherapy in chronic lymphocytic leukemia patients. Haematologica. 2022 Mar 1;107(3):615-624. doi: 10.3324/haematol.2020.251561.'}, {'pmid': '33131249', 'type': 'DERIVED', 'citation': 'Jaramillo S, Agathangelidis A, Schneider C, Bahlo J, Robrecht S, Tausch E, Bloehdorn J, Hoechstetter M, Fischer K, Eichhorst B, Goede V, Hallek M, Dohner H, Rosenquist R, Ghia P, Stamatopoulos K, Stilgenbauer S. Prognostic impact of prevalent chronic lymphocytic leukemia stereotyped subsets: analysis within prospective clinical trials of the German CLL Study Group (GCLLSG). Haematologica. 2020 Nov 1;105(11):2598-2607. doi: 10.3324/haematol.2019.231027.'}, {'pmid': '32735048', 'type': 'DERIVED', 'citation': 'Kreuzberger N, Damen JA, Trivella M, Estcourt LJ, Aldin A, Umlauff L, Vazquez-Montes MD, Wolff R, Moons KG, Monsef I, Foroutan F, Kreuzer KA, Skoetz N. Prognostic models for newly-diagnosed chronic lymphocytic leukaemia in adults: a systematic review and meta-analysis. Cochrane Database Syst Rev. 2020 Jul 31;7(7):CD012022. doi: 10.1002/14651858.CD012022.pub2.'}, {'pmid': '29255066', 'type': 'DERIVED', 'citation': 'Dimier N, Delmar P, Ward C, Morariu-Zamfir R, Fingerle-Rowson G, Bahlo J, Fischer K, Eichhorst B, Goede V, van Dongen JJM, Ritgen M, Bottcher S, Langerak AW, Kneba M, Hallek M. A model for predicting effect of treatment on progression-free survival using MRD as a surrogate end point in CLL. Blood. 2018 Mar 1;131(9):955-962. doi: 10.1182/blood-2017-06-792333. Epub 2017 Dec 18.'}, {'pmid': '26486789', 'type': 'DERIVED', 'citation': 'Fischer K, Bahlo J, Fink AM, Goede V, Herling CD, Cramer P, Langerbeins P, von Tresckow J, Engelke A, Maurer C, Kovacs G, Herling M, Tausch E, Kreuzer KA, Eichhorst B, Bottcher S, Seymour JF, Ghia P, Marlton P, Kneba M, Wendtner CM, Dohner H, Stilgenbauer S, Hallek M. Long-term remissions after FCR chemoimmunotherapy in previously untreated patients with CLL: updated results of the CLL8 trial. Blood. 2016 Jan 14;127(2):208-15. doi: 10.1182/blood-2015-06-651125. Epub 2015 Oct 20.'}, {'pmid': '24916506', 'type': 'DERIVED', 'citation': 'Weisser M, Yeh RF, Duchateau-Nguyen G, Palermo G, Nguyen TQ, Shi X, Stinson SY, Yu N, Dufour A, Robak T, Salogub GN, Dmoszynska A, Solal-Celigny P, Warzocha K, Loscertales J, Catalano J, Larratt L, Rossiev VA, Bence-Bruckler I, Geisler CH, Montillo M, Fischer K, Fink AM, Hallek M, Bloehdorn J, Busch R, Benner A, Dohner H, Valente N, Wenger MK, Stilgenbauer S, Dornan D. PTK2 expression and immunochemotherapy outcome in chronic lymphocytic leukemia. Blood. 2014 Jul 17;124(3):420-5. doi: 10.1182/blood-2013-12-538975. Epub 2014 Jun 10.'}, {'pmid': '24797299', 'type': 'DERIVED', 'citation': 'Pflug N, Bahlo J, Shanafelt TD, Eichhorst BF, Bergmann MA, Elter T, Bauer K, Malchau G, Rabe KG, Stilgenbauer S, Dohner H, Jager U, Eckart MJ, Hopfinger G, Busch R, Fink AM, Wendtner CM, Fischer K, Kay NE, Hallek M. Development of a comprehensive prognostic index for patients with chronic lymphocytic leukemia. Blood. 2014 Jul 3;124(1):49-62. doi: 10.1182/blood-2014-02-556399. Epub 2014 May 5.'}, {'pmid': '24652989', 'type': 'DERIVED', 'citation': 'Stilgenbauer S, Schnaiter A, Paschka P, Zenz T, Rossi M, Dohner K, Buhler A, Bottcher S, Ritgen M, Kneba M, Winkler D, Tausch E, Hoth P, Edelmann J, Mertens D, Bullinger L, Bergmann M, Kless S, Mack S, Jager U, Patten N, Wu L, Wenger MK, Fingerle-Rowson G, Lichter P, Cazzola M, Wendtner CM, Fink AM, Fischer K, Busch R, Hallek M, Dohner H. Gene mutations and treatment outcome in chronic lymphocytic leukemia: results from the CLL8 trial. Blood. 2014 May 22;123(21):3247-54. doi: 10.1182/blood-2014-01-546150. Epub 2014 Mar 20.'}, {'pmid': '21139079', 'type': 'DERIVED', 'citation': 'Eichhorst BF, Fischer K, Fink AM, Elter T, Wendtner CM, Goede V, Bergmann M, Stilgenbauer S, Hopfinger G, Ritgen M, Bahlo J, Busch R, Hallek M; German CLL Study Group (GCLLSG). Limited clinical relevance of imaging techniques in the follow-up of patients with advanced chronic lymphocytic leukemia: results of a meta-analysis. Blood. 2011 Feb 10;117(6):1817-21. doi: 10.1182/blood-2010-04-282228. Epub 2010 Dec 7.'}, {'pmid': '20888994', 'type': 'DERIVED', 'citation': 'Hallek M, Fischer K, Fingerle-Rowson G, Fink AM, Busch R, Mayer J, Hensel M, Hopfinger G, Hess G, von Grunhagen U, Bergmann M, Catalano J, Zinzani PL, Caligaris-Cappio F, Seymour JF, Berrebi A, Jager U, Cazin B, Trneny M, Westermann A, Wendtner CM, Eichhorst BF, Staib P, Buhler A, Winkler D, Zenz T, Bottcher S, Ritgen M, Mendila M, Kneba M, Dohner H, Stilgenbauer S; International Group of Investigators; German Chronic Lymphocytic Leukaemia Study Group. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet. 2010 Oct 2;376(9747):1164-74. doi: 10.1016/S0140-6736(10)61381-5.'}]}, 'descriptionModule': {'briefSummary': 'This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to see how well they work compared to fludarabine and cyclophosphamide in treating patients with B-cell chronic lymphocytic leukemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Diagnosed B-cell chronic lymphocytic leukemia (CLL) defined by the National Cancer Institute (NCI) Working Group criteria\n* Meets 1 of the following criteria:\n\n * Binet stage C disease\n * Binet stage B disease AND ≥ 1 of the following signs or symptoms\\*:\n\n * B symptoms (night sweats, weight loss ≥ 10% within the previous 6 months, fevers \\> 38°C or 100.4°F for ≥ 2 weeks without evidence of infection), or constitutional symptoms (fatigue)\n * Continuous progression (doubling of peripheral lymphocyte count within the past 6 months and absolute lymphocyte count \\> 50 G/I)\n * Evidence of progressive marrow failure as manifested by the development/worsening of anemia and/or thrombocytopenia\n * Massive, progressive or painful splenomegaly or hypersplenism\n * Massive lymph nodes or lymph node clusters (\\> 10 cm in longest diameter), danger of organ complications through large lymphoma (e.g., vascular compression or tracheal narrowing), or progressive lymphadenopathy\n * Occurrence of symptomatic hyperviscosity problems at leukocyte counts \\> 200 G/I (symptomatic leukostasis) NOTE: \\* Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for eligibility\n* No Binet stage A disease\n* No transformation to an aggressive B-cell malignancy (e.g., diffuse large cell lymphoma, Richter's syndrome, or prolymphocytic leukemia)\n\nPATIENT CHARACTERISTICS:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Cumulative Illness Rating Scale (CIRS) score \\> 6\n* Life expectancy \\> 6 months\n* Bilirubin ≤ 2 times upper limit of normal (ULN)\n* Alkaline phosphatase and transaminases ≤ 2 times ULN\n* Creatinine clearance ≥ 70 mL/min\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 2 months after study treatment\n* No known hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the study drugs\n* No cerebral dysfunction that precludes chemotherapy\n* No active bacterial, viral, or fungal infection\n* No clinically significant autoimmune cytopenia or Coombs-positive hemolytic anemia\n* No other active malignancy requiring concurrent treatment except basal cell carcinoma or tumors treated curatively by surgery\n* No medical or psychological condition that would preclude study therapy\n* No concurrent disease that requires prolonged (\\> 1 month) therapy involving glucocorticoids\n\nPRIOR CONCURRENT THERAPY:\n\n* No previous treatment of CLL by chemotherapy, radiotherapy, or immunotherapy"}, 'identificationModule': {'nctId': 'NCT00281918', 'acronym': 'CLL-8', 'briefTitle': 'Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Phase III Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab (FCR) Versus Chemotherapy With Fludarabine and Cyclophosphamide (FC) Alone in Patients With Previously Untreated Chronic Lymphocytic Leukaemia', 'orgStudyIdInfo': {'id': 'CDR0000454560'}, 'secondaryIdInfos': [{'id': 'GCLLSG-CLL-8'}, {'id': 'EU-20560'}, {'id': 'ML17102'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fludarabine+Cyclophosphamide+Rituximab (FCR)', 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