Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-29 @ 2:22 PM
Study NCT ID:
NCT01292603
Status:
COMPLETED
Last Update Posted:
2018-12-19
First Post:
2011-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Compare Subcutaneous Versus Intravenous MabThera (Rituximab) in Combination With Chemotherapy in Patients With Chronic Lymphocytic Leukemia
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': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '1-800-821-8590', '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 from the time of initiation of treatment until 28 days after completion of study treatment in Cycle 6.', 'description': 'New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: Rituximab SC 1400 mg', 'description': 'Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1400 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).', 'otherNumAtRisk': 16, 'otherNumAffected': 13, 'seriousNumAtRisk': 16, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Part 1: Rituximab SC 1600 mg', 'description': 'Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).', 'otherNumAtRisk': 17, 'otherNumAffected': 16, 'seriousNumAtRisk': 17, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Part 1: Rituximab SC 1870 mg', 'description': 'PParticipant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).', 'otherNumAtRisk': 22, 'otherNumAffected': 21, 'seriousNumAtRisk': 22, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Part 1: Rituximab SC 1000 mg', 'description': 'One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error.\n\nParticipant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Part 1: No SC Dose Received', 'description': 'These participants were withdrawn prior to SC treatment.', 'otherNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'Part 2 : Rituximab IV 500 mg/m^2', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).', 'otherNumAtRisk': 89, 'otherNumAffected': 80, 'seriousNumAtRisk': 89, 'seriousNumAffected': 35}, {'id': 'EG006', 'title': 'Part 2: Rituximab SC 1600 mg', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).', 'otherNumAtRisk': 85, 'otherNumAffected': 81, 'seriousNumAtRisk': 85, 'seriousNumAffected': 32}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 51}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 54}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 15}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 21}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 25}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Agranulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Granulocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 31}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 20}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Gingival erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 23}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, 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'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'ACUTE KIDNEY INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Dermatitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Rash Maculo- Papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'ENTEROCOLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20,1)'}, {'term': 'BACTERIAL SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'BARTHOLINITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'MYELODYSPLASTIC SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'PROSTATE CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'ACUTE RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'ANAL ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'MOUTH ULCERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'BRONCHOPULMONARY ASPERGILLOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'SEPTIC SHOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'STAPHYLOCOCCAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'VARICELLA ZOSTER VIRUS INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'BASAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': "BOWEN'S DISEASE", 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'BREAST CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'DIFFUSE LARGE B-CELL LYMPHOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': "HODGKIN'S DISEASE", 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'METASTATIC SQUAMOUS CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'PAPILLARY THYROID CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'REFRACTORY ANAEMIA WITH AN EXCESS OF BLASTS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA (20.1)'}, {'term': 'SQUAMOUS CELL CARCINOMA OF SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'THYROID CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'ENCEPHALITIS AUTOIMMUNE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: Subcutaneous Rituximab Dose Resulting in Trough Concentration (Ctrough) Levels Non-Inferior to Intravenous Rituximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Rituximab SC', 'description': 'Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}], 'classes': [{'categories': [{'measurements': [{'value': '1600', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-dose and post-dose (15 minutes to end of infusion) on Day 1 and on Days 2, 5, 11 and 15 of Cycle 5 and Pre-dose, Post-dose on Days 2, 3, 5,11, 15 and 29 of Cycle 6; Pre-dose was taken 2 hours prior rituximab dose', 'description': 'Ctrough is defined as the trough or minimum serum concentration. Pharmacokinetic parameters for rituximab were assessed during Cycles 5 (IV rituximab) and 6 (SC rituximab). Rituximab pharmacokinetic (PK) data from Part 1 were integrated into a population PK model using parametric, nonlinear, mixed-effects modelling. Rituximab IV 500 mg/m\\^2 administered once every 4 weeks was compared to fixed doses of rituximab SC between 1400 mg and 1870 mg. The dose selection was performed on Ctrough concentrations at Cycle 5 (pre-dose Cycle 6). A test of the probability of success was applied to each of the 100 replicates, and the percentage of replicates with a positive test corresponded to the probability of success of the trial.', 'unitOfMeasure': 'mg', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled (non-randomized) Pharmacokinetic Evaluable Population (Part 1) included all participants from Part 1 who did not significantly violate the inclusion or exclusion criteria, deviate significantly from the protocol or have unavailable or incomplete data which could influence the pharmacokinetic analysis.'}, {'type': 'PRIMARY', 'title': 'Part 2: Rituximab C Trough Levels at Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 : Rituximab IV 500 mg/m^2', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'OG001', 'title': 'Part 2: Rituximab SC 1600 mg', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}], 'classes': [{'categories': [{'measurements': [{'value': '61.50', 'spread': '89.54', 'groupId': 'OG000'}, {'value': '97.53', 'spread': '55.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.533', 'ciLowerLimit': '1.269', 'ciUpperLimit': '1.852', 'estimateComment': 'Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A standard non-inferiority margin of 0.8 for the ratio of Ctrough was used. The non-inferiority limit corresponds to a maximal 20 percent (%) loss in Ctrough which is considered acceptable given the high variability and range of Ctrough data, with an 80% power and a one-sided alpha of 0.05.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '+/- 25hours around the 28th day post the 5th Cycle of Rituximab administration', 'description': 'Ctrough is defined as the trough or minimum serum concentration in a given cycle of treatment. The objective of Part 2 was to demonstrate the comparability of the observed Ctrough of rituximab SC 1600 mg and rituximab IV 500 mg/m2 at Cycle 5, as assessed by a non-inferiority test with a lower boundary of at least 0.8 for the 90% CI.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who entered Part 2 of the study and had pharmacokinetic (PK) data available were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Part 2: Observed Area Under the Serum Concentration-Curve (AUC) of Rituximab at Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 : Rituximab IV 500 mg/m^2', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'OG001', 'title': 'Part 2: Rituximab SC 1600 mg', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}], 'classes': [{'categories': [{'measurements': [{'value': '3630.43', 'spread': '38.61', 'groupId': 'OG000'}, {'value': '4088.78', 'spread': '37.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.102', 'ciLowerLimit': '0.979', 'ciUpperLimit': '1.242', 'estimateComment': 'Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6', 'description': 'AUC values were calculated by numerical integration using the linear trapezoidal rule. AUC levels were analyzed using the model below: Ln(AUC) = μ + τi + BlTLij + εij wherein, Ln is the natural log, μ denotes the overall mean effect, τi the effect in each treatment group, BlTLij the tumor load at baseline for each patient and εij a random error variable with normal distribution and mean 0. The treatment effect therein was based on a contrast statement in the model to calculate 90 % confidence intervals for ln(AUC SC)- ln(AUC IV).', 'unitOfMeasure': 'μg*day/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who entered Part 2 of the study and had PK data available were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Part 2: Maximum Observed Concentration (Cmax) of Rituximab at Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 : Rituximab IV 500 mg/m^2', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'OG001', 'title': 'Part 2: Rituximab SC 1600 mg', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}], 'classes': [{'categories': [{'measurements': [{'value': '279.78', 'spread': '23.96', 'groupId': 'OG000'}, {'value': '202.16', 'spread': '36.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.719', 'ciLowerLimit': '0.653', 'ciUpperLimit': '0.792', 'estimateComment': 'Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6', 'description': 'Cmax was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of rituximab in the blood samplings.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who entered Part 2 of the study and had PK data available were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Part 2: Time to Cmax (Tmax) of Rituximab at Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 : Rituximab IV 500 mg/m^2', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'OG001', 'title': 'Part 2: Rituximab SC 1600 mg', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.22', 'spread': '130.84', 'groupId': 'OG000'}, {'value': '3.14', 'spread': '87.62', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '14.884', 'ciLowerLimit': '11.215', 'ciUpperLimit': '19.755', 'estimateComment': 'Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6', 'description': 'Multiple blood samples were obtained at pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6 in Rituximab IV arm, and at pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6 in Rituximab SC arm and time to peak plasma concentration of rituximab was determined.', 'unitOfMeasure': 'days', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who entered Part 2 of the study and had PK data available were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Part 2: Terminal Half-Life of Rituximab at Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 : Rituximab IV 500 mg/m^2', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'OG001', 'title': 'Part 2: Rituximab SC 1600 mg', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}], 'classes': [{'categories': [{'measurements': [{'value': '30.09', 'spread': '41.86', 'groupId': 'OG000'}, {'value': '30.71', 'spread': '33.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.010', 'ciLowerLimit': '0.895', 'ciUpperLimit': '1.139', 'estimateComment': 'Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6', 'description': 'The terminal half-life (t1/2) of rituximab is defined as the time required for the plasma concentration of rituximab to reach half of its original concentration.', 'unitOfMeasure': 'days', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who entered Part 2 of the study and had PK data available were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants and Nurses Recording a Preference For Either SC or IV Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Rituximab SC 1400 mg', 'description': 'Participant could have been enrolled any time during treatment with rituximab IV in combination with fludarabine/cyclophosphamide (FC) prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1400 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'OG001', 'title': 'Part 1: Rituximab SC 1600 mg', 'description': 'Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'OG002', 'title': 'Part 1: Rituximab SC 1870 mg', 'description': 'Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}], 'classes': [{'title': 'Participants who preferred SC', 'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '91.0', 'groupId': 'OG002'}]}]}, {'title': 'Participants who preferred IV', 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '9.0', 'groupId': 'OG002'}]}]}, {'title': 'Nurses who preferred SC', 'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '91.0', 'groupId': 'OG002'}]}]}, {'title': 'Nurses who preferred IV', 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '9.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 4 to 5 in Cycle 6', 'description': 'In part 1 of the trial, upon completion of dosing in cycle 6, participants and their treating nurses were asked whether they have a preference of dosing route, IV vs SC', 'unitOfMeasure': 'percentage of participants or nurses', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Part 1 were included in this analysis including 8 participants that did not receive SC rituximab.'}, {'type': 'SECONDARY', 'title': 'Part 2: Physician/Nurse Opinion on Time Savings With Rituximab SC Compared With Rituximab IV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 : Rituximab IV 500 mg/m^2', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'OG001', 'title': 'Part 2: Rituximab SC 1600 mg', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}], 'classes': [{'title': 'Nurse: 4 or more hours', 'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000'}, {'value': '21.0', 'groupId': 'OG001'}]}]}, {'title': 'Nurse: At least 3 hours but less than 4 hours', 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000'}, {'value': '29.0', 'groupId': 'OG001'}]}]}, {'title': 'Nurse: At least 2 hours but less than 3 hours', 'categories': [{'measurements': [{'value': '26.0', 'groupId': 'OG000'}, {'value': '23.0', 'groupId': 'OG001'}]}]}, {'title': 'Nurse: At least 1 hour but less than 2 hours', 'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000'}, {'value': '11.0', 'groupId': 'OG001'}]}]}, {'title': 'Nurse: Less than 1 hour', 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000'}, {'value': '16.0', 'groupId': 'OG001'}]}]}, {'title': 'Physician: 4 or more hours', 'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000'}, {'value': '22.0', 'groupId': 'OG001'}]}]}, {'title': 'Physician: At least 3 hours but less than 4 hours', 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000'}, {'value': '21.0', 'groupId': 'OG001'}]}]}, {'title': 'Physician: At least 2 hours but less than 3 hours', 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000'}, {'value': '26.0', 'groupId': 'OG001'}]}]}, {'title': 'Physician: At least 1 hour but less than 2 hours', 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000'}, {'value': '19.0', 'groupId': 'OG001'}]}]}, {'title': 'Physician: Less than 1 hour', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '7.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 4-5 in Cycle 6', 'description': 'Physicians and nurses who administered rituximab were asked to answer the following question: " If used in routine practice, on average, how much staff time could be saved with each administration of rituximab SC as compared to rituximab IV? (Please do not consider the time needed for the first IV administration, consider only the subsequent ones)". The number of nurses that responded for both the IV and SC arms was 70. The number of physicians that responded for the IV and SC arms were 78 and 81 respectively.', 'unitOfMeasure': 'percentage of participants in the survey', 'reportingStatus': 'POSTED', 'populationDescription': 'All the physicians and nurses who responded to the questionnaire were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Part 2: Physician/Nurse Opinion on Convenience of Rituximab SC Compared With Rituximab IV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 : Rituximab IV 500 mg/m^2', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'OG001', 'title': 'Part 2: Rituximab SC 1600 mg', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}], 'classes': [{'title': 'Nurse: Rituximab SC is much more convenient', 'categories': [{'measurements': [{'value': '81.0', 'groupId': 'OG000'}, {'value': '77.0', 'groupId': 'OG001'}]}]}, {'title': 'Nurse: Rituximab SC is a little more convenient', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000'}, {'value': '9.0', 'groupId': 'OG001'}]}]}, {'title': 'Nurse: Both formulations are equally convenient', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000'}, {'value': '4.0', 'groupId': 'OG001'}]}]}, {'title': 'Nurse: Rituximab IV is a little more convenient', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}]}]}, {'title': 'Nurse: Rituximab IV is much more convenient', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Physician: Rituximab SC is much more convenient', 'categories': [{'measurements': [{'value': '78.0', 'groupId': 'OG000'}, {'value': '80.0', 'groupId': 'OG001'}]}]}, {'title': 'Physician: Rituximab SC a little more convenient', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000'}, {'value': '14.0', 'groupId': 'OG001'}]}]}, {'title': 'Physician: Both formulations equally convenient', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000'}, {'value': '6.0', 'groupId': 'OG001'}]}]}, {'title': 'Physician: Rituximab IV a little more convenient', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Physician: Rituximab IV is much more convenient', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 4-5 in Cycle 6', 'description': 'Physicians and nurses who administered rituximab were asked to answer the following question: "Which formulation of rituximab (SC or IV) do you think is more convenient?" with pre-specified responses as below. Percentage of participants with specified answers were reported. The number of nurses that responded for both the IV and SC arms was 70. The number of physicians that responded for the IV and SC arms were 78 and 81 respectively.', 'unitOfMeasure': 'percentage of participants in the survey', 'reportingStatus': 'POSTED', 'populationDescription': 'All the physicians and nurses who responded to the questionnaire were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants With Anti-Rituximab Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Rituximab SC', 'description': 'Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}], 'classes': [{'title': 'Pre-Dose Cycle 5: positive for HACAs (n=59)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Pre-Dose Cycle 5: negative for HACAs (n=59)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Post-Dose: positive for HACAs (n=61)', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}]}]}, {'title': 'Post-Dose: negative for HACAs (n=61)', 'categories': [{'measurements': [{'value': '95.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Predose at Cycles 5 and 6 and at each follow up visit until 24 months after the last dose', 'description': 'Blood samples for the assessment of antibodies against rituximab (HACAs) were drawn pre-dose at Cycle 5 and Cycle 6 in Part 1 and at each follow up visit until 24 months after the last dose.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Population (SAP): all participants who received at least one dose of study medication, whether prematurely withdrawn from the study or not. This included 8 participants that did not receive SC rituximab. n = number of participants analyzed.'}, {'type': 'SECONDARY', 'title': 'Part 2: Percentage of Participants With Anti-Rituximab Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 : Rituximab IV 500 mg/m^2', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'OG001', 'title': 'Part 2: Rituximab SC 1600 mg', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}], 'classes': [{'title': 'Baseline pre Cycle 1: positive for HACAs (n=87,85)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Baseline pre Cycle 1: negative for HACAs (n=87,85)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '97.6', 'groupId': 'OG001'}]}]}, {'title': 'Post-Baseline: positive for HACAs (n=89,85)', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000'}, {'value': '12.0', 'groupId': 'OG001'}]}]}, {'title': 'Post-Baseline: negative for HACAs (n=89,85)', 'categories': [{'measurements': [{'value': '85.0', 'groupId': 'OG000'}, {'value': '88.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 of Cycle 1 and Day 1 of Cycles 1, 2, 3, 4, 5, and 6 and at each follow-up visit until 24 months after the last dose of rituximab.', 'description': 'In Part 2, samples for the HACA assay were collected at each treatment cycle prior to the administration of rituximab and at each follow-up visit until 24 months after the last dose of rituximab.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAP; n = number of participants analyzed for the specific parameter.'}, {'type': 'SECONDARY', 'title': 'Part 1: Total Cluster Differentiation19 Positive (CD19+) B-Cell Counts by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Rituximab SC 1400 Milligrams (mg)', 'description': 'Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1400 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'OG001', 'title': 'Part 1: Rituximab SC 1600 mg', 'description': 'Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'OG002', 'title': 'Part 1: Rituximab SC 1870 mg', 'description': 'Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'OG003', 'title': 'Part 1: Rituximab SC 1000 mg', 'description': 'One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error.\n\nParticipant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'OG004', 'title': 'Part 1: No SC Dose Received', 'description': 'These participants were withdrawn prior to SC treatment.'}], 'classes': [{'title': 'Cycle 5 Day 1 (n=15,13,19,1,2)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '157'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '419'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '19'}, {'value': '84', 'comment': 'Only 1 participant was analyzed in this group.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '2'}]}]}, {'title': 'Cycle 6 Day 1 (n=15,14,18,1,0)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '90'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '22'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '27', 'comment': 'Only 1 participant was analyzed in this group.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FU 28 Day Visit (n=15,11,19,1,0)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '113'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '7', 'comment': 'Only 1 participant was analyzed in this group.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FU 56 Day Visit (n=15,9,15,1,0)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '215'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '42'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '14', 'comment': 'Only 1 participant was analyzed in this group.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FU 3 Month Visit (n=16,8,18,0,0)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '469'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FU 6 Month Visit (n=15,13,17,1,0)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5929'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '265'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '96'}, {'value': '51', 'comment': 'Only 1 participant was analyzed in this group.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FU 9 Month Visit (n=15,13,15,1,0)', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '15727'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '728'}, {'value': '29', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '1153'}, {'value': '74', 'comment': 'Only 1 participant was analyzed in this group.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FU 12 Month Visit (n=14,14,20,0,0)', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '1457'}, {'value': '31', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2775'}, {'value': '90', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '1281'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FU 15 Month Visit (n=14,11,15,0,0)', 'categories': [{'measurements': [{'value': '175', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '2426'}, {'value': '41', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '6588'}, {'value': '106', 'groupId': 'OG002', 'lowerLimit': '29', 'upperLimit': '500'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FU 18 Month Visit (n=13,14,15,0,0)', 'categories': [{'measurements': [{'value': '175', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '5871'}, {'value': '82', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '13749'}, {'value': '189', 'groupId': 'OG002', 'lowerLimit': '22', 'upperLimit': '478'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FU 21 Month Visit (n=13,12,16,0,0)', 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '10679'}, {'value': '78', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '314'}, {'value': '149', 'groupId': 'OG002', 'lowerLimit': '57', 'upperLimit': '783'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FU 24 Month Visit(n=12, 4,16,0,0)', 'categories': [{'measurements': [{'value': '238', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '11989'}, {'value': '110', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '2225'}, {'value': '232', 'groupId': 'OG002', 'lowerLimit': '69', 'upperLimit': '1343'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 of Cycles 5 and 6 and Follow-up Days 28 and 56 and Follow-up Visits at Months 3, 6, 9, 12, 15,18, 21 and 24', 'description': 'CD 19 is a surface antigen (protein) present on B-lymphocytes.', 'unitOfMeasure': 'cells per microliter (cells/μL)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 1 SAP; n = number of participants analyzed at the specified visit.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants With Total B-Cell Depletion by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Rituximab SC 1400 mg', 'description': 'Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1400 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'OG001', 'title': 'Part 1: Rituximab SC 1600 mg', 'description': 'Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'OG002', 'title': 'Part 1: Rituximab SC 1870 mg', 'description': 'Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'OG003', 'title': 'Rituximab SC 1000 mg', 'description': 'Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'OG004', 'title': 'Part 1: No SC Dose Received', 'description': 'These participants were withdrawn prior to SC treatment.'}], 'classes': [{'title': 'Cycle 5 Day 1 (n=15,1319,1,2)', 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000'}, {'value': '92.3', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 6 Day 1(n= 15,14,18,1,0)', 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG004'}]}]}, {'title': 'FU 28 Day Visit (n=15,11,19,1,0)', 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG004'}]}]}, {'title': 'FU 56 Day Visit (n=15,9,15,1,0)', 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG004'}]}]}, {'title': 'FU 3 Month Visit (n=16,8,18,0,0)', 'categories': [{'measurements': [{'value': '93.8', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG004'}]}]}, {'title': 'FU 6 Month Visit (n=15,13,17,1,0)', 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000'}, {'value': '92.3', 'groupId': 'OG001'}, {'value': '94.1', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG004'}]}]}, {'title': 'FU 9 Month Visit (n=15,13,15,1,0)', 'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000'}, {'value': '84.6', 'groupId': 'OG001'}, {'value': '60.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG004'}]}]}, {'title': 'FU 12 Month Visit (n=14,14,20,0,0)', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '85.7', 'groupId': 'OG001'}, {'value': '45.0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG004'}]}]}, {'title': 'FU 15 Month Visit (n=14,11,15,0,0)', 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000'}, {'value': '54.5', 'groupId': 'OG001'}, {'value': '40.0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG004'}]}]}, {'title': 'FU 18 Month Visit (n=13,14,15,0,0)', 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '26.7', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG004'}]}]}, {'title': 'FU 21 Month Visit (n=13,12,16,0,0)', 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '18.8', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG004'}]}]}, {'title': 'FU 24 Month Visit (n=12,14,16,0,0)', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}, {'value': '18.8', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'No participants were analyzed in this group.', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 pre-dose of Cycles 5 and 6 and Follow-up Days 28 and 56 and Follow-up Visits at Months 3, 6, 9, 12, 15, 18, 21 and 24', 'description': 'Total B-cell depletion (normal B-cell plus Malignant B-cell depletion) was defined for each individual participant when the sum of CD5-/CD19+ (normal B-cells) and CD5+/CD19+ (malignant B-cells) cell counts decreased below 80 cells/μL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 1 SAP; n = number of participants analyzed at the specified visit.'}, {'type': 'SECONDARY', 'title': 'Part 2: Total CD19+ B-Cell Counts by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 : Rituximab IV 500 mg/m^2', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'OG001', 'title': 'Part 2: Rituximab SC 1600 mg', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}], 'classes': [{'title': 'Cycle 1 - Baseline (n=80,80)', 'categories': [{'measurements': [{'value': '68905', 'groupId': 'OG000', 'lowerLimit': '3996', 'upperLimit': '277645'}, {'value': '50565', 'groupId': 'OG001', 'lowerLimit': '640', 'upperLimit': '453292'}]}]}, {'title': 'Cycle 2 - Pre-dose (n=71,74)', 'categories': [{'measurements': [{'value': '338', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '38252'}, {'value': '253', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '92469'}]}]}, {'title': 'Cycle 2 - Post-dose (n=65, 66)', 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '13026'}, {'value': '168', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '32615'}]}]}, {'title': 'Cycle 2 Day 2 (n=54, 59)', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '10416'}, {'value': '266', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '40815'}]}]}, {'title': 'Cycle 2 Day 3 (n=48, 54)', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '14769'}, {'value': '125', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '13229'}]}]}, {'title': 'Cycle 3 Day 1 (n=67,68)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '13118'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '22392'}]}]}, {'title': 'Cycle 4 Day 1 (n=71,69)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '17827'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '18672'}]}]}, {'title': 'Cycle 5 Day 1 (n=68,67)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7146'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8542'}]}]}, {'title': 'Cycle 6 Day 1 (n=71,64)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3612'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4234'}]}]}, {'title': 'FU 28 Day Visit (n=66,64)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1299'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2749'}]}]}, {'title': 'FU 56 Day Visit (n=63,67)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '14331'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3539'}]}]}, {'title': 'FU 3 Month Visit (n=67,67)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '39037'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '16413'}]}]}, {'title': 'FU 6 Month Visit (n=60,69)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1356'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '22630'}]}]}, {'title': 'FU 9 Month Visit (n=65,64)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3776'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '890'}]}]}, {'title': 'FU 12 Month Visit (n=60,61)', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '9372'}, {'value': '104', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '1770'}]}]}, {'title': 'FU 15 Month Visit (n=59,60)', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '16328'}, {'value': '171', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '9431'}]}]}, {'title': 'FU 18 Month Visit (n=57,58)', 'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '15404'}, {'value': '223', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '22363'}]}]}, {'title': 'FU 21 Month Visit (n=55,52)', 'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '7901'}, {'value': '277', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '39435'}]}]}, {'title': 'FU 24 Month Visit (n=56,51)', 'categories': [{'measurements': [{'value': '214', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '78010'}, {'value': '256', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '10482'}]}]}, {'title': 'Withdrawn/Termination (n=17,15)', 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '90310'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '35325'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 pre-dose, 60 minutes post-dose, Days 2 and 3 in Cycle 2, day 1 pre-dose in Cycles 3, 4, 5 and 6, Follow-up Days 28 and 56, and Follow-up Visits at Months 3, 6, 9, 12, 15, and 18 and Withdrawal Visit', 'description': 'CD 19 is a surface antigen (protein) present on B-lymphocytes.', 'unitOfMeasure': 'cells/μL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 2 SAP; n = number of participants analyzed at the specified visit.'}, {'type': 'SECONDARY', 'title': 'Part 2: Percentage of Participants With Total B-Cell Depletion by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 : Rituximab IV 500 mg/m^2', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'OG001', 'title': 'Part 2: Rituximab SC 1600 mg', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}], 'classes': [{'title': 'Cycle 1 - Baseline (n=80,80))', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 - Pre-dose (n=71, 74)', 'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000'}, {'value': '31.1', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 - Post-dose (n=65, 66)', 'categories': [{'measurements': [{'value': '32.3', 'groupId': 'OG000'}, {'value': '37.9', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 2 (n=54, 59)', 'categories': [{'measurements': [{'value': '35.2', 'groupId': 'OG000'}, {'value': '30.5', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 3 (n=48, 54)', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '37.0', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 1 (n=67,68)', 'categories': [{'measurements': [{'value': '73.1', 'groupId': 'OG000'}, {'value': '76.5', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4 Day 1 (n=71,69)', 'categories': [{'measurements': [{'value': '83.1', 'groupId': 'OG000'}, {'value': '84.1', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5 Day 1 (n=68,67)', 'categories': [{'measurements': [{'value': '88.2', 'groupId': 'OG000'}, {'value': '89.6', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6 Day 1 (n=71,64)', 'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000'}, {'value': '95.3', 'groupId': 'OG001'}]}]}, {'title': 'FU 28 Day Visit (n=66,64)', 'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000'}, {'value': '96.9', 'groupId': 'OG001'}]}]}, {'title': 'FU 56 Day Visit (n=63,67)', 'categories': [{'measurements': [{'value': '92.1', 'groupId': 'OG000'}, {'value': '97.0', 'groupId': 'OG001'}]}]}, {'title': 'FU 3 Month Visit (n=67,67)', 'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000'}, {'value': '92.5', 'groupId': 'OG001'}]}]}, {'title': 'FU 6 Month Visit (n=60,69)', 'categories': [{'measurements': [{'value': '88.3', 'groupId': 'OG000'}, {'value': '91.3', 'groupId': 'OG001'}]}]}, {'title': 'FU 9 Month Visit (n=65,64)', 'categories': [{'measurements': [{'value': '66.2', 'groupId': 'OG000'}, {'value': '70.3', 'groupId': 'OG001'}]}]}, {'title': 'FU 12 Month Visit (n=60,61)', 'categories': [{'measurements': [{'value': '43.3', 'groupId': 'OG000'}, {'value': '42.6', 'groupId': 'OG001'}]}]}, {'title': 'FU 15 Month Visit (n=59,60)', 'categories': [{'measurements': [{'value': '33.9', 'groupId': 'OG000'}, {'value': '30.0', 'groupId': 'OG001'}]}]}, {'title': 'FU 18 Month Visit (n=57,58)', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '25.9', 'groupId': 'OG001'}]}]}, {'title': 'FU 21 Month Visit (n=55,52)', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000'}, {'value': '19.2', 'groupId': 'OG001'}]}]}, {'title': 'FU 24 Month Visit (n=56,51)', 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000'}, {'value': '15.7', 'groupId': 'OG001'}]}]}, {'title': 'Withdrawn/Termination (n=17,15)', 'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000'}, {'value': '73.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 Pre-dose, 60 minutes post-dose, Days 2 and 3 in Cycle 2, day 1 in Cycles 3, 4, 5 and 6, Follow-up Days 28 and 56, and Follow-up Visits at Months 3, 6, 9, 12, 15, and 18 and Withdrawal Visit', 'description': 'Total B-cell depletion (normal B-cell plus Malignant B-cell depletion) was defined for each individual participant when the sum of CD5-/CD19+ (normal B-cells) and CD5+/CD19+ (malignant B-cells) cell counts decreased below 80 cells/μL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 2 SAP; n= number of participants analyzed at the specified visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: Rituximab SC 1400 Milligrams (mg)', 'description': 'Participant could have been enrolled any time during their treatment with rituximab IV in combination with fludarabine/cyclophosphamide (FC) prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 milligrams per square meter (mg/m\\^2) on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1400 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'FG001', 'title': 'Part 1: Rituximab SC 1600 mg', 'description': 'Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'FG002', 'title': 'Part 1: Rituximab SC 1870 mg', 'description': 'Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'FG003', 'title': 'Part 1: No SC Dose Received', 'description': 'These participants were withdrawn prior to SC treatment.'}, {'id': 'FG004', 'title': 'Part 2 : Rituximab IV 500 mg/m^2', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'FG005', 'title': 'Part 2: Rituximab SC 1600 mg', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}], 'periods': [{'title': 'Part 1: Pilot Dose Selection Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'comment': '1 participant received a dose of 1000mg of rituximab by oversight.', 'groupId': 'FG002', 'numSubjects': '23'}, {'comment': 'These participants were withdrawn prior to SC treatment.', 'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Part 1: Regular Follow-Up Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Participants withdrawn from regular follow-up who were still alive entered survival follow-up', 'groupId': 'FG000', 'numSubjects': '10'}, {'comment': 'Participants withdrawn from regular follow-up who were still alive entered survival follow-up', 'groupId': 'FG001', 'numSubjects': '10'}, {'comment': 'Participants withdrawn from regular follow-up who were still alive entered survival follow-up', 'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Part 2: Dose Confirmation Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '88'}, {'groupId': 'FG005', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '72'}, {'groupId': 'FG005', 'numSubjects': '73'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawn Prior to Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}]}, {'title': 'Part 2: Regular Follow-Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Participants withdrawn from regular follow-up who were still alive entered survival follow-up', 'groupId': 'FG004', 'numSubjects': '87'}, {'comment': 'Participants withdrawn from regular follow-up who were still alive entered survival follow-up', 'groupId': 'FG005', 'numSubjects': '87'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '68'}, {'groupId': 'FG005', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '19'}, {'groupId': 'FG005', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}]}, {'title': 'Overall Survival Status', 'milestones': [{'type': 'STARTED', 'comment': 'Patients could enter survival follow-up directly after premature treatment withdrawal,', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '88'}, {'groupId': 'FG005', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'comment': 'Overall survival.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '72'}, {'groupId': 'FG005', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '10'}]}]}], 'preAssignmentDetails': 'In Part 1 a single dose of subcutaneous (SC) rituximab was administered at Cycle 6 to select a dose resulting in trough concentration (Ctrough) non-inferior to intravenous (IV) dose. In Part 2, participants were randomized to receive rituximab IV or SC, to demonstrate non-inferiority of rituximab Ctrough levels of SC dose compared with IV dose.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}, {'value': '85', 'groupId': 'BG004'}, {'value': '229', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: Rituximab SC 1400 Milligrams (mg)', 'description': 'Participant could have been enrolled any time during their treatment with rituximab IV in combination with fludarabine/cyclophosphamide (FC) prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1400 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'BG001', 'title': 'Part 1: Rituximab SC 1600 mg', 'description': 'Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'BG002', 'title': 'Part 1: Rituximab SC 1870 mg', 'description': 'Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'BG003', 'title': 'Part 2 : Rituximab IV 500 mg/m^2', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'BG004', 'title': 'Part 2: Rituximab SC 1600 mg', 'description': 'Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'spread': '10.13', 'groupId': 'BG000'}, {'value': '60.4', 'spread': '8.18', 'groupId': 'BG001'}, {'value': '56.9', 'spread': '6.79', 'groupId': 'BG002'}, {'value': '58.7', 'spread': '9.03', 'groupId': 'BG003'}, {'value': '59.1', 'spread': '8.87', 'groupId': 'BG004'}, {'value': '58.8', 'spread': '8.8', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '76', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '153', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Population (SAP): all participants who received at least one dose of study medication whether prematurely withdrawn or not. In Part 2 two participants randomized to the rituximab SC 1600 mg arm were included in Rituximab IV 500 mg/m\\^2 arm as they received only the first cycle of rituximab IV 375 mg/m\\^2.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-17', 'studyFirstSubmitDate': '2011-02-08', 'resultsFirstSubmitDate': '2015-09-23', 'studyFirstSubmitQcDate': '2011-02-08', 'lastUpdatePostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-11-10', 'studyFirstPostDateStruct': {'date': '2011-02-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Subcutaneous Rituximab Dose Resulting in Trough Concentration (Ctrough) Levels Non-Inferior to Intravenous Rituximab', 'timeFrame': 'Pre-dose and post-dose (15 minutes to end of infusion) on Day 1 and on Days 2, 5, 11 and 15 of Cycle 5 and Pre-dose, Post-dose on Days 2, 3, 5,11, 15 and 29 of Cycle 6; Pre-dose was taken 2 hours prior rituximab dose', 'description': 'Ctrough is defined as the trough or minimum serum concentration. Pharmacokinetic parameters for rituximab were assessed during Cycles 5 (IV rituximab) and 6 (SC rituximab). Rituximab pharmacokinetic (PK) data from Part 1 were integrated into a population PK model using parametric, nonlinear, mixed-effects modelling. Rituximab IV 500 mg/m\\^2 administered once every 4 weeks was compared to fixed doses of rituximab SC between 1400 mg and 1870 mg. The dose selection was performed on Ctrough concentrations at Cycle 5 (pre-dose Cycle 6). A test of the probability of success was applied to each of the 100 replicates, and the percentage of replicates with a positive test corresponded to the probability of success of the trial.'}, {'measure': 'Part 2: Rituximab C Trough Levels at Cycle 5', 'timeFrame': '+/- 25hours around the 28th day post the 5th Cycle of Rituximab administration', 'description': 'Ctrough is defined as the trough or minimum serum concentration in a given cycle of treatment. The objective of Part 2 was to demonstrate the comparability of the observed Ctrough of rituximab SC 1600 mg and rituximab IV 500 mg/m2 at Cycle 5, as assessed by a non-inferiority test with a lower boundary of at least 0.8 for the 90% CI.'}], 'secondaryOutcomes': [{'measure': 'Part 2: Observed Area Under the Serum Concentration-Curve (AUC) of Rituximab at Cycle 6', 'timeFrame': 'Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6', 'description': 'AUC values were calculated by numerical integration using the linear trapezoidal rule. AUC levels were analyzed using the model below: Ln(AUC) = μ + τi + BlTLij + εij wherein, Ln is the natural log, μ denotes the overall mean effect, τi the effect in each treatment group, BlTLij the tumor load at baseline for each patient and εij a random error variable with normal distribution and mean 0. The treatment effect therein was based on a contrast statement in the model to calculate 90 % confidence intervals for ln(AUC SC)- ln(AUC IV).'}, {'measure': 'Part 2: Maximum Observed Concentration (Cmax) of Rituximab at Cycle 6', 'timeFrame': 'Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6', 'description': 'Cmax was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of rituximab in the blood samplings.'}, {'measure': 'Part 2: Time to Cmax (Tmax) of Rituximab at Cycle 6', 'timeFrame': 'Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6', 'description': 'Multiple blood samples were obtained at pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6 in Rituximab IV arm, and at pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6 in Rituximab SC arm and time to peak plasma concentration of rituximab was determined.'}, {'measure': 'Part 2: Terminal Half-Life of Rituximab at Cycle 6', 'timeFrame': 'Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6', 'description': 'The terminal half-life (t1/2) of rituximab is defined as the time required for the plasma concentration of rituximab to reach half of its original concentration.'}, {'measure': 'Part 1: Percentage of Participants and Nurses Recording a Preference For Either SC or IV Administration', 'timeFrame': 'Days 4 to 5 in Cycle 6', 'description': 'In part 1 of the trial, upon completion of dosing in cycle 6, participants and their treating nurses were asked whether they have a preference of dosing route, IV vs SC'}, {'measure': 'Part 2: Physician/Nurse Opinion on Time Savings With Rituximab SC Compared With Rituximab IV', 'timeFrame': 'Days 4-5 in Cycle 6', 'description': 'Physicians and nurses who administered rituximab were asked to answer the following question: " If used in routine practice, on average, how much staff time could be saved with each administration of rituximab SC as compared to rituximab IV? (Please do not consider the time needed for the first IV administration, consider only the subsequent ones)". The number of nurses that responded for both the IV and SC arms was 70. The number of physicians that responded for the IV and SC arms were 78 and 81 respectively.'}, {'measure': 'Part 2: Physician/Nurse Opinion on Convenience of Rituximab SC Compared With Rituximab IV', 'timeFrame': 'Days 4-5 in Cycle 6', 'description': 'Physicians and nurses who administered rituximab were asked to answer the following question: "Which formulation of rituximab (SC or IV) do you think is more convenient?" with pre-specified responses as below. Percentage of participants with specified answers were reported. The number of nurses that responded for both the IV and SC arms was 70. The number of physicians that responded for the IV and SC arms were 78 and 81 respectively.'}, {'measure': 'Part 1: Percentage of Participants With Anti-Rituximab Antibodies', 'timeFrame': 'Predose at Cycles 5 and 6 and at each follow up visit until 24 months after the last dose', 'description': 'Blood samples for the assessment of antibodies against rituximab (HACAs) were drawn pre-dose at Cycle 5 and Cycle 6 in Part 1 and at each follow up visit until 24 months after the last dose.'}, {'measure': 'Part 2: Percentage of Participants With Anti-Rituximab Antibodies', 'timeFrame': 'Day 0 of Cycle 1 and Day 1 of Cycles 1, 2, 3, 4, 5, and 6 and at each follow-up visit until 24 months after the last dose of rituximab.', 'description': 'In Part 2, samples for the HACA assay were collected at each treatment cycle prior to the administration of rituximab and at each follow-up visit until 24 months after the last dose of rituximab.'}, {'measure': 'Part 1: Total Cluster Differentiation19 Positive (CD19+) B-Cell Counts by Visit', 'timeFrame': 'Day 1 of Cycles 5 and 6 and Follow-up Days 28 and 56 and Follow-up Visits at Months 3, 6, 9, 12, 15,18, 21 and 24', 'description': 'CD 19 is a surface antigen (protein) present on B-lymphocytes.'}, {'measure': 'Part 1: Percentage of Participants With Total B-Cell Depletion by Visit', 'timeFrame': 'Day 1 pre-dose of Cycles 5 and 6 and Follow-up Days 28 and 56 and Follow-up Visits at Months 3, 6, 9, 12, 15, 18, 21 and 24', 'description': 'Total B-cell depletion (normal B-cell plus Malignant B-cell depletion) was defined for each individual participant when the sum of CD5-/CD19+ (normal B-cells) and CD5+/CD19+ (malignant B-cells) cell counts decreased below 80 cells/μL.'}, {'measure': 'Part 2: Total CD19+ B-Cell Counts by Visit', 'timeFrame': 'Cycle 1 pre-dose, 60 minutes post-dose, Days 2 and 3 in Cycle 2, day 1 pre-dose in Cycles 3, 4, 5 and 6, Follow-up Days 28 and 56, and Follow-up Visits at Months 3, 6, 9, 12, 15, and 18 and Withdrawal Visit', 'description': 'CD 19 is a surface antigen (protein) present on B-lymphocytes.'}, {'measure': 'Part 2: Percentage of Participants With Total B-Cell Depletion by Visit', 'timeFrame': 'Cycle 1 Pre-dose, 60 minutes post-dose, Days 2 and 3 in Cycle 2, day 1 in Cycles 3, 4, 5 and 6, Follow-up Days 28 and 56, and Follow-up Visits at Months 3, 6, 9, 12, 15, and 18 and Withdrawal Visit', 'description': 'Total B-cell depletion (normal B-cell plus Malignant B-cell depletion) was defined for each individual participant when the sum of CD5-/CD19+ (normal B-cells) and CD5+/CD19+ (malignant B-cells) cell counts decreased below 80 cells/μL.'}]}, 'conditionsModule': {'conditions': ['Lymphocytic Leukemia, Chronic']}, 'referencesModule': {'references': [{'pmid': '26947201', 'type': 'DERIVED', 'citation': 'Assouline S, Buccheri V, Delmer A, Gaidano G, Trneny M, Berthillon N, Brewster M, Catalani O, Li S, McIntyre C, Sayyed P, Badoux X. Pharmacokinetics, safety, and efficacy of subcutaneous versus intravenous rituximab plus chemotherapy as treatment for chronic lymphocytic leukaemia (SAWYER): a phase 1b, open-label, randomised controlled non-inferiority trial. Lancet Haematol. 2016 Mar;3(3):e128-38. doi: 10.1016/S2352-3026(16)00004-1.'}, {'pmid': '25900065', 'type': 'DERIVED', 'citation': 'Assouline S, Buccheri V, Delmer A, Gaidano G, McIntyre C, Brewster M, Catalani O, Hourcade-Potelleret F, Sayyed P, Badoux X. Pharmacokinetics and safety of subcutaneous rituximab plus fludarabine and cyclophosphamide for patients with chronic lymphocytic leukaemia. Br J Clin Pharmacol. 2015 Nov;80(5):1001-9. doi: 10.1111/bcp.12662. Epub 2015 Jul 29.'}, {'pmid': '24265828', 'type': 'DERIVED', 'citation': 'Mao CP, Brovarney MR, Dabbagh K, Birnbock HF, Richter WF, Del Nagro CJ. Subcutaneous versus intravenous administration of rituximab: pharmacokinetics, CD20 target coverage and B-cell depletion in cynomolgus monkeys. PLoS One. 2013 Nov 12;8(11):e80533. doi: 10.1371/journal.pone.0080533. eCollection 2013.'}, {'pmid': '24002601', 'type': 'DERIVED', 'citation': 'Shpilberg O, Jackisch C. Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase. Br J Cancer. 2013 Sep 17;109(6):1556-61. doi: 10.1038/bjc.2013.371. Epub 2013 Sep 3.'}]}, 'descriptionModule': {'briefSummary': 'This randomized, parallel-group, multi-center study will compare the pharmacokinetics and safety of subcutaneous administration of MabThera (rituximab) versus intravenous MabThera in combination with chemotherapy in previously untreated patients with chronic lymphocytic leukemia (CLL). The study consists of 2 parts. In part 1, patients who have previously received 4 cycles of intravenous MabThera will receive in Cycle 5 intravenous MabThera and in Cycle 6 subcutaneous MabThera. In part 2, patients will be randomized to receive either 6 cycles of intravenous MabThera, or 1 cycle of intravenous MabThera and 5 cycles of subcutaneous MabThera. Additionally, all patients will receive chemotherapy (fludarabine and cyclophosphamide) on Days 1-3 or Days 1-5 of every cycle. The anticipated time on study drug is 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/=18 years of age\n* Patients with treatment-requiring chronic lymphocytic leukemia (CLL)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Life expectancy \\>6 months\n\nExclusion Criteria:\n\n* Transformation to aggressive B-cell malignancy\n* History of other malignancy unless the patient was treated with curative intent and has been in remission for more than 5 years prior to enrolment\n* HIV or Hepatitis B positive unless clearly due to vaccination\n* Inadequate liver or renal function\n* Any coexisting medical or psychological condition that would preclude participation in the required study procedures\n\nAdditional exclusion criterion for Part 1:\n\n* Any previous treatment for CLL except for up to 4 cycles of rituximab IV in combination with FC chemotherapy as first-line treatment for CLL\n\nAdditional exclusion criterion for Part 2:\n\n* Any previous treatment for CLL'}, 'identificationModule': {'nctId': 'NCT01292603', 'briefTitle': 'A Study to Compare Subcutaneous Versus Intravenous MabThera (Rituximab) in Combination With Chemotherapy in Patients With Chronic Lymphocytic Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Adaptive, Comparative, Randomized, Parallel-group, Multi Center, Phase Ib Study of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With Chemotherapy (Fludarabine and Cyclophosphamide), in Patients With Previously Untreated CLL', 'orgStudyIdInfo': {'id': 'BO25341'}, 'secondaryIdInfos': [{'id': '2010-021380-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Fludarabine', 'Drug: rituximab [MabThera]']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Fludarabine', 'Drug: rituximab [MabThera]']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Fludarabine', 'Drug: rituximab [MabThera]']}], 'interventions': [{'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Days 1-3 or Days 1-5 of cycles 1-6', 'armGroupLabels': ['1', '2', '3']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Days 1-3 or Days 1-5 of cycles 1-6', 'armGroupLabels': ['1', '2', '3']}, {'name': 'rituximab [MabThera]', 'type': 'DRUG', 'description': 'One cycle of intravenous MabThera, followed by 5 cycles of subcutaneous MabThera', 'armGroupLabels': ['3']}, {'name': 'rituximab [MabThera]', 'type': 'DRUG', 'description': 'After 4 cycles of intravenous MabThera without experiencing grade 3 or 4 infusion-related reactions. patients will receive 1 additional cycle of intravenous MabThera and 1 cycle of subcutaneous MabThera.', 'armGroupLabels': ['1']}, {'name': 'rituximab [MabThera]', 'type': 'DRUG', 'description': '6 cycles of intravenous MabThera', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1114AAN', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Fundaleu; 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