Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-02-19 @ 10:57 PM
Study NCT ID:
NCT00090051
Status:
COMPLETED
Last Update Posted:
2017-08-01
First Post:
2004-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'C042382', 'term': 'fludarabine phosphate'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], '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': {'email': 'global.clinical_trial_registry@roche.com', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected from study start to 28 days after treatment completion (Median observation time= 26 months). Serious Adverse Events were collected 1 year after treatment completion (Median observation time= 37 months).', 'description': 'The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up, whether withdrawn prematurely or not. 272 patients received FC only and 274 patients received FCR.', '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': 272, 'otherNumAffected': 232, 'seriousNumAtRisk': 272, 'seriousNumAffected': 132}, {'id': 'EG001', 'title': 'Fludarabine+Cyclophosphamide+Rituximab (FCR)', 'description': 'Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.', 'otherNumAtRisk': 274, 'otherNumAffected': 251, 'seriousNumAtRisk': 274, 'seriousNumAffected': 138}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 120}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 55}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 36}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Granulocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 60}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 110}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 57}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 34}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 20}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 23}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 20}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Acute Coronary Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Acute Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Agranulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Alpha Haemolytic Streptococcal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anaemia Haemolytic Autoimmune', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Aplasia Pure Red Cell', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Autoimmune Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bacterial Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Basal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bicytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bladder Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bone Marrow Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Brain Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchitis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchopulmonary Aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cardiopulmonary Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chest Wall Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chondrosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chronic Myelomonocytic Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Colitis Ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Colon Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Coronary Artery Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cytomegalovirus Gastrointestinal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cytomegalovirus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Endocarditis Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 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Exacerbation of Chronic Obstructive Airways Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Zygomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Renal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thyroid Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, 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malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Mycobacterial Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '276', '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 and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '660', 'groupId': 'OG000', 'lowerLimit': '556', 'upperLimit': '735'}, {'value': '813', 'groupId': 'OG001', 'lowerLimit': '670', 'upperLimit': '947'}]}]}], 'analyses': [{'pValue': '0.0218', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.60', 'ciUpperLimit': '0.96', 'estimateComment': 'The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the fludarabine+cyclophosphamide(FC) group.', 'groupDescription': 'The null hypothesis was that there was no difference between the 2 treatment groups. The alternative hypothesis was that progression-free survival was longer in the fludarabine+cyclophosphamide+rituximab (FCR) group.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'non-stratified'}], 'paramType': 'MEDIAN', 'timeFrame': 'Mean observation time at time of analysis was approximately 26 months', 'description': 'Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause, whichever came first. Patients without a PFS event were censored at their last tumor assessment date.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '276', '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 and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '1580', 'comment': 'The upper limit could not be estimated due to too low number of events at time of analysis.', 'groupId': 'OG000', 'lowerLimit': '1408', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median survival time could not be estimated due to too low number of events at time of analysis.', 'groupId': 'OG001', 'lowerLimit': '1552', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.2874', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'non-stratified'}], 'paramType': 'MEDIAN', 'timeFrame': 'Mean observation time at time of analysis was approximately 26 months', 'description': 'Overall survival was determined from the date of randomization to the date of death irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Overall Survival (OS) Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '276', '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 and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.'}], 'classes': [{'title': 'Patients with event', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Patients without events', 'categories': [{'measurements': [{'value': '208', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Mean observation time at time of analysis was approximately 26 months', 'description': 'Overall survival was determined from the date of randomization to the date of death (OS event) irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.'}, {'type': 'SECONDARY', 'title': 'Event-free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '276', '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 and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '586', 'groupId': 'OG000', 'lowerLimit': '545', 'upperLimit': '731'}, {'value': '874', 'groupId': 'OG001', 'lowerLimit': '756', 'upperLimit': '1187'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'non-stratified'}], 'paramType': 'MEDIAN', 'timeFrame': 'Mean observation time at time of analysis was approximately 26 months', 'description': 'Event free survival was measured from the day of randomization to the date of first documented PD, relapse after response, start of a new treatment or death from any cause. Patients without an EFS event were censored at their last tumor assessment date.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Event-free Survival (EFS) Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '276', '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 and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.'}], 'classes': [{'title': 'Patients with event', 'categories': [{'measurements': [{'value': '162', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}]}, {'title': 'Patients without events', 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Mean observation time at time of analysis was approximately 26 months', 'description': 'Event free survival was measured from the day of randomization to the date of first documented Progressive Disease (PD), relapse after response, start of a new treatment or death from any cause (EFS events). Patients without an EFS event were censored at their last tumor assessment date.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '276', '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 and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.'}], 'classes': [{'title': 'Patients with event', 'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}]}, {'title': 'Patients without events', 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Mean observation time at time of analysis was approximately 26 months', 'description': 'Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause (PFS events), whichever came first. Patients without a PFS event were censored at their last tumor assessment date.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.'}, {'type': 'SECONDARY', 'title': 'Disease-free Survival (DFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '67', '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 and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '1285', 'comment': 'The upper limit could not be estimated due to too low number of events at time of analysis.', 'groupId': 'OG000', 'lowerLimit': '791', 'upperLimit': 'NA'}, {'value': '1204', 'comment': 'The upper limit could not be estimated due to too low number of events at time of analysis.', 'groupId': 'OG001', 'lowerLimit': '938', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.8842', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'non-stratified'}], 'paramType': 'MEDIAN', 'timeFrame': 'Mean observation time at time of analysis was approximately 26 months', 'description': 'Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause. Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population for patients with a Best Overall Response of Complete Response.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Disease-free Survival (DFS) Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '67', '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 and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.'}], 'classes': [{'title': 'Patients with event', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Patients without event', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Mean observation time at time of analysis was approximately 26 months', 'description': 'Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause (DFS events). Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population with a Best Overall Response of Complete Response.'}, {'type': 'PRIMARY', 'title': 'Final Analysis: Time to Progression-Free Survival Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '205', '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 and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '683.0', 'groupId': 'OG000', 'lowerLimit': '554', 'upperLimit': '797'}, {'value': '969.0', 'groupId': 'OG001', 'lowerLimit': '809', 'upperLimit': '1195'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.54', 'ciUpperLimit': '0.80', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Median observation time was approximately 5 years', 'description': 'Time to progression-free survival (PFS) event was defined as the time between randomization and the date of first documented PFS event: 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, all randomized participants, who experienced a PFS event. Participants who did not have a PFS event at the time of the final analysis were censored at the date of the last contact.'}, {'type': 'SECONDARY', 'title': 'Final Analysis: Time to Overall Survival Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '144', '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 and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '2056.0', 'groupId': 'OG000', 'lowerLimit': '1883', 'upperLimit': '2344'}, {'value': '2167.0', 'groupId': 'OG001', 'lowerLimit': '1898', 'upperLimit': '2438'}]}]}], 'analyses': [{'pValue': '0.5976', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.19', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Median observation time was approximately 5 years', 'description': 'Overall survival (OS) was determined from the date of randomization to the date of death (OS event) irrespective of cause.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis included only those participants from the Intent-to-treat population,all randomized participants, who died. Participants who had not died at the time of the final analysis were censored at the date of the last contact.'}, {'type': 'SECONDARY', 'title': 'Final Analysis: Time to Event-Free Survival Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', '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 and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '630.0', 'groupId': 'OG000', 'lowerLimit': '548', 'upperLimit': '747'}, {'value': '932.0', 'groupId': 'OG001', 'lowerLimit': '777', 'upperLimit': '1187'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.54', 'ciUpperLimit': '0.79', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Median observation time was approximately 5 years', 'description': 'Event free survival (EFS) was defined as the time from the day of randomization to the date of first EFS event: documented disease progression, relapse after response, start of a new treatment or death from any cause.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, who had an EFS event. Participants who did not have an ESF event at the time of the final analysis were censored at the date of the last contact.'}, {'type': 'SECONDARY', 'title': 'Final Analysis: Percentage of Participants With Complete Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '276', '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 and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.15', 'ciLowerLimit': '1.39', 'ciUpperLimit': '3.35', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Median observation time was approximately 5 years', 'description': 'Complete response was defined as the disappearance of all signs of cancer in response to treatment.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Final Analysis: Time to Disease-Free Survival Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '69', '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 and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '1285.0', 'groupId': 'OG000', 'lowerLimit': '996', 'upperLimit': '1541'}, {'value': '1803.0', 'groupId': 'OG001', 'lowerLimit': '938', 'upperLimit': '2071'}]}]}], 'analyses': [{'pValue': '0.3085', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.46', 'ciUpperLimit': '1.28', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Median observation time was approximately 5 years', 'description': 'Time to disease-free survival (DFS) event was defined as the time from first documented response until the first documented DFS event: disease progression, relapse or death from any cause.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with complete response. .'}, {'type': 'SECONDARY', 'title': 'Final Analysis: Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '194', '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 and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '869.0', 'groupId': 'OG000', 'lowerLimit': '801', 'upperLimit': '1107'}, {'value': '1333.0', 'groupId': 'OG001', 'lowerLimit': '1025', 'upperLimit': '1632'}]}]}], 'analyses': [{'pValue': '0.0007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.51', 'ciUpperLimit': '0.84', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Median observation time was approximately 5 years', 'description': 'Duration of response was defined as the time between the date of the earliest qualifying response and the date of disease progression or death due to any cause.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with complete or partial response.'}, {'type': 'SECONDARY', 'title': 'Final Analysis: Time to New Chronic Lymphocytic Leukemia (CLL) Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '173', '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 and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '1085.0', 'groupId': 'OG000', 'lowerLimit': '997', 'upperLimit': '1290'}, {'value': '1625.0', 'groupId': 'OG001', 'lowerLimit': '1350', 'upperLimit': '1805'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.55', 'ciUpperLimit': '0.84', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Median observation time was approximately 5 years', 'description': 'Time to new CCL treatment was defined as the time from randomization to the first day of new treatment for CCL or death.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population,all randomized participants, who started a new treatment for CLL or died.'}]}, '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 and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '276'}, {'groupId': 'FG001', 'numSubjects': '276'}]}, {'type': 'Safety Population; Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '272'}, {'groupId': 'FG001', 'numSubjects': '274'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed 6 Cycles of Treatment', 'groupId': 'FG000', 'numSubjects': '167'}, {'comment': 'Completed 6 Cycles of Treatment', 'groupId': 'FG001', 'numSubjects': '181'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '95'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '552', '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 and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.3', 'spread': '9.11', 'groupId': 'BG000'}, {'value': '62.1', 'spread': '9.17', 'groupId': 'BG001'}, {'value': '61.7', 'spread': '9.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '368', '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': 552}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'dispFirstSubmitDate': '2009-07-09', 'completionDateStruct': {'date': '2012-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-05', 'studyFirstSubmitDate': '2004-08-23', 'dispFirstSubmitQcDate': '2009-09-10', 'resultsFirstSubmitDate': '2009-12-22', 'studyFirstSubmitQcDate': '2004-08-24', 'dispFirstPostDateStruct': {'date': '2009-09-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-12-15', 'studyFirstPostDateStruct': {'date': '2004-08-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)', 'timeFrame': 'Mean observation time at time of analysis was approximately 26 months', 'description': 'Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause, whichever came first. Patients without a PFS event were censored at their last tumor assessment date.'}, {'measure': 'Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC)', 'timeFrame': 'Mean observation time at time of analysis was approximately 26 months', 'description': 'Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause (PFS events), whichever came first. Patients without a PFS event were censored at their last tumor assessment date.'}, {'measure': 'Final Analysis: Time to Progression-Free Survival Event', 'timeFrame': 'Median observation time was approximately 5 years', 'description': 'Time to progression-free survival (PFS) event was defined as the time between randomization and the date of first documented PFS event: disease progression, relapse or death by any cause, whichever came first.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Mean observation time at time of analysis was approximately 26 months', 'description': 'Overall survival was determined from the date of randomization to the date of death irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact.'}, {'measure': 'Number of Participants With Overall Survival (OS) Events', 'timeFrame': 'Mean observation time at time of analysis was approximately 26 months', 'description': 'Overall survival was determined from the date of randomization to the date of death (OS event) irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact.'}, {'measure': 'Event-free Survival (EFS)', 'timeFrame': 'Mean observation time at time of analysis was approximately 26 months', 'description': 'Event free survival was measured from the day of randomization to the date of first documented PD, relapse after response, start of a new treatment or death from any cause. Patients without an EFS event were censored at their last tumor assessment date.'}, {'measure': 'Number of Participants With Event-free Survival (EFS) Events', 'timeFrame': 'Mean observation time at time of analysis was approximately 26 months', 'description': 'Event free survival was measured from the day of randomization to the date of first documented Progressive Disease (PD), relapse after response, start of a new treatment or death from any cause (EFS events). Patients without an EFS event were censored at their last tumor assessment date.'}, {'measure': 'Disease-free Survival (DFS)', 'timeFrame': 'Mean observation time at time of analysis was approximately 26 months', 'description': 'Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause. Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date.'}, {'measure': 'Number of Participants With Disease-free Survival (DFS) Events', 'timeFrame': 'Mean observation time at time of analysis was approximately 26 months', 'description': 'Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause (DFS events). Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date.'}, {'measure': 'Final Analysis: Time to Overall Survival Event', 'timeFrame': 'Median observation time was approximately 5 years', 'description': 'Overall survival (OS) was determined from the date of randomization to the date of death (OS event) irrespective of cause.'}, {'measure': 'Final Analysis: Time to Event-Free Survival Event', 'timeFrame': 'Median observation time was approximately 5 years', 'description': 'Event free survival (EFS) was defined as the time from the day of randomization to the date of first EFS event: documented disease progression, relapse after response, start of a new treatment or death from any cause.'}, {'measure': 'Final Analysis: Percentage of Participants With Complete Response', 'timeFrame': 'Median observation time was approximately 5 years', 'description': 'Complete response was defined as the disappearance of all signs of cancer in response to treatment.'}, {'measure': 'Final Analysis: Time to Disease-Free Survival Event', 'timeFrame': 'Median observation time was approximately 5 years', 'description': 'Time to disease-free survival (DFS) event was defined as the time from first documented response until the first documented DFS event: disease progression, relapse or death from any cause.'}, {'measure': 'Final Analysis: Duration of Response', 'timeFrame': 'Median observation time was approximately 5 years', 'description': 'Duration of response was defined as the time between the date of the earliest qualifying response and the date of disease progression or death due to any cause.'}, {'measure': 'Final Analysis: Time to New Chronic Lymphocytic Leukemia (CLL) Treatment', 'timeFrame': 'Median observation time was approximately 5 years', 'description': 'Time to new CCL treatment was defined as the time from randomization to the first day of new treatment for CCL or death.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Lymphocytic Leukemia']}, 'referencesModule': {'references': [{'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': '23525797', 'type': 'DERIVED', 'citation': 'Dufour A, Palermo G, Zellmeier E, Mellert G, Duchateau-Nguyen G, Schneider S, Benthaus T, Kakadia PM, Spiekermann K, Hiddemann W, Braess J, Truong S, Patten N, Wu L, Lohmann S, Dornan D, GuhaThakurta D, Yeh RF, Salogub G, Solal-Celigny P, Dmoszynska A, Robak T, Montillo M, Catalano J, Geisler CH, Weisser M, Bohlander SK. Inactivation of TP53 correlates with disease progression and low miR-34a expression in previously treated chronic lymphocytic leukemia patients. Blood. 2013 May 2;121(18):3650-7. doi: 10.1182/blood-2012-10-458695. Epub 2013 Mar 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to provide treatment for patients who have chronic lymphocytic leukemia (CLL), and to compare the use of rituximab added to fludarabine+cyclophosphamide (FC) with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Established diagnosis of B-cell CLL by NCI Working Group criteria\n* ≤1 previous line of chemotherapy\n* Expected survival \\>6 months\n* Acceptable hematologic status, liver function, renal function, and pulmonary function\n* Negative serum pregnancy test for both pre-menopausal women and for women who are \\< 2 years after the onset of menopause\n* Written informed consent\n\nExclusion Criteria:\n\n* Prior treatment with interferon, rituximab or other monoclonal antibody\n* Prior allogeneic bone marrow transplant (BMT) or autologous BMT or peripheral stem cell transplant (PBSCT) or patients who are considered to be candidates for allogeneic or autologous BMT or PSCT as assessed by their treating physician\n* Fertile men or women of childbearing potential not using adequate contraception\n* Severe Grade 3 or 4 non-hematological toxicity or prolonged (\\> 2 weeks) Grade 3 or 4 cytopenia on prior fludarabine or nucleoside analogue regimen\n* History of fludarabine-induced or clinically significant autoimmune cytopenia\n* History of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; 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