Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-02-11 @ 3:30 PM
Study NCT ID:
NCT01649856
Status:
COMPLETED
Last Update Posted:
2017-10-11
First Post:
2012-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['India']}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-LaRoche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 4.25 years', 'description': 'Safety Population.', 'eventGroups': [{'id': 'EG000', 'title': 'Rituximab SC', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.', 'otherNumAtRisk': 369, 'otherNumAffected': 319, 'seriousNumAtRisk': 369, 'seriousNumAffected': 155}, {'id': 'EG001', 'title': 'Rituximab IV', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.', 'otherNumAtRisk': 203, 'otherNumAffected': 172, 'seriousNumAtRisk': 203, 'seriousNumAffected': 77}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 104}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 54}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 40}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 47}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 48}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 43}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 18}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Febrile bone marrow aplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'H1N1 influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Herpes oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Herpes simplex hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Klebsiella sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Neutropenic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pneumocystis jirovecii infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pneumocystis jirovecii pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 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inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Embolism venous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Subclavian vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Adjustment disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Bile duct obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Gastroenteritis norovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Intervertebral discitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lower respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pneumonia cytomegaloviral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Small intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ill-defined disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Procedural pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Metastatic renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Prostate cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Arterial disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cytokine release syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab SC', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}, {'id': 'OG001', 'title': 'Rituximab IV', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.6', 'groupId': 'OG000', 'lowerLimit': '45.2', 'upperLimit': '56.0'}, {'value': '42.4', 'groupId': 'OG001', 'lowerLimit': '35.0', 'upperLimit': '50.0'}]}]}], 'analyses': [{'pValue': '0.076', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Response Rates', 'ciPctValue': '95', 'paramValue': '8.2', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '17.5', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 4.25 years', 'description': 'Tumor response was assessed per criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by greater than (\\>) 75 percent (%) but still \\>1.5 centimeters (cm) in size, and indeterminate bone marrow assessment. The percentage of participants with either response at the end of induction (EOI) was determined with corresponding 95% Pearson-Clopper confidence interval (CI).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: All participants who completed Baseline and at least one on-treatment efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab SC', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}, {'id': 'OG001', 'title': 'Rituximab IV', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}], 'classes': [{'title': 'Expectations of Therapy (n=280,141)', 'categories': [{'measurements': [{'value': '79.35', 'spread': '17.422', 'groupId': 'OG000'}, {'value': '82.94', 'spread': '16.536', 'groupId': 'OG001'}]}]}, {'title': 'Feelings about Side Effects (n=276,141)', 'categories': [{'measurements': [{'value': '60.69', 'spread': '21.594', 'groupId': 'OG000'}, {'value': '57.62', 'spread': '23.339', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction with Therapy (n=278,141)', 'categories': [{'measurements': [{'value': '85.92', 'spread': '11.428', 'groupId': 'OG000'}, {'value': '83.60', 'spread': '13.451', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Cycle 7 (each cycle was 14 or 21 days)', 'description': 'The CTSQ is a validated 16-item questionnaire that measures three domains related to satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (CTSQ Subpopulation): All participants who completed the CTSQ at Cycles 3 and 7; number (n) = number of participants in the analysis for the specified domain.'}, {'type': 'SECONDARY', 'title': 'Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab SC', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}, {'id': 'OG001', 'title': 'Rituximab IV', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}], 'classes': [{'title': 'Physical Impact (n=278,140)', 'categories': [{'measurements': [{'value': '86.24', 'spread': '14.012', 'groupId': 'OG000'}, {'value': '81.49', 'spread': '16.848', 'groupId': 'OG001'}]}]}, {'title': 'Psychological Impact (n=277,141)', 'categories': [{'measurements': [{'value': '85.65', 'spread': '13.920', 'groupId': 'OG000'}, {'value': '78.65', 'spread': '18.233', 'groupId': 'OG001'}]}]}, {'title': 'Impact on ADLs (n=266,140)', 'categories': [{'measurements': [{'value': '83.77', 'spread': '16.117', 'groupId': 'OG000'}, {'value': '57.38', 'spread': '19.230', 'groupId': 'OG001'}]}]}, {'title': 'Convenience (n=279,143)', 'categories': [{'measurements': [{'value': '82.32', 'spread': '13.428', 'groupId': 'OG000'}, {'value': '60.14', 'spread': '17.473', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction (n=282,141)', 'categories': [{'measurements': [{'value': '89.58', 'spread': '12.051', 'groupId': 'OG000'}, {'value': '77.39', 'spread': '18.232', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Cycle 7 (each cycle was 14 or 21 days)', 'description': 'The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (RASQ Subpopulation): All participants who completed the RASQ at Cycles 3 and 7; n = number of participants in the analysis for the specified domain.'}, {'type': 'SECONDARY', 'title': 'Median Duration of Rituximab Administration for Each Treatment Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab SC', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}, {'id': 'OG001', 'title': 'Rituximab IV', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}], 'classes': [{'title': 'Cycle 1 (n=346,190)', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '11.00'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '1.20', 'upperLimit': '10.00'}]}]}, {'title': 'Cycle 2 (n=361,178)', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '23.10'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '10.00'}]}]}, {'title': 'Cycle 3 (n=349,177)', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '5.50'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '21.40'}]}]}, {'title': 'Cycle 4 (n=346,173)', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '2.50'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '8.00'}]}]}, {'title': 'Cycle 5 (n=332,165)', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '2.50'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '0.10', 'upperLimit': '8.10'}]}]}, {'title': 'Cycle 6 (n=319,162)', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '2.50'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '0.10', 'upperLimit': '20.00'}]}]}, {'title': 'Cycle 7 (n=304,156)', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '23.60'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '6.70'}]}]}, {'title': 'Cycle 8 (n=305,152)', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '2.50'}, {'value': '2.55', 'groupId': 'OG001', 'lowerLimit': '0.10', 'upperLimit': '17.90'}]}]}, {'title': 'Overall (n=368,201)', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '28.70'}, {'value': '19.00', 'groupId': 'OG001', 'lowerLimit': '1.20', 'upperLimit': '57.40'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)', 'description': 'Duration of rituximab administration was defined as the time from start to end of the SC injection or IV infusion. The median duration was reported.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population; n = number of participants in the analysis for the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab SC', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}, {'id': 'OG001', 'title': 'Rituximab IV', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}], 'classes': [{'title': 'Less than 30 minutes (Cycle 1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '30 minutes to 1 hour (Cycle 1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}]}]}, {'title': '1 to 2 hours (Cycle 1)', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '2 to 4 hours (Cycle 1)', 'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000'}, {'value': '17.2', 'groupId': 'OG001'}]}]}, {'title': '4 to 12 hours (Cycle 1)', 'categories': [{'measurements': [{'value': '69.4', 'groupId': 'OG000'}, {'value': '72.4', 'groupId': 'OG001'}]}]}, {'title': 'More than 12 hours (Cycle 1)', 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}, {'value': '7.9', 'groupId': 'OG001'}]}]}, {'title': 'Missing (Cycle 1)', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Less than 30 minutes (Cycle 2)', 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '30 minutes to 1 hour (Cycle 2)', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '1 to 2 hours (Cycle 2)', 'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': '2 to 4 hours (Cycle 2)', 'categories': [{'measurements': [{'value': '56.1', 'groupId': 'OG000'}, {'value': '36.2', 'groupId': 'OG001'}]}]}, {'title': '4 to 12 hours (Cycle 2)', 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000'}, {'value': '60.1', 'groupId': 'OG001'}]}]}, {'title': 'More than 12 hours (Cycle 2)', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Missing (Cycle 2)', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Less than 30 minutes (Cycle 3)', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '30 minutes to 1 hour (Cycle 3)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '1 to 2 hours (Cycle 3)', 'categories': [{'measurements': [{'value': '22.1', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}]}]}, {'title': '2 to 4 hours (Cycle 3)', 'categories': [{'measurements': [{'value': '55.9', 'groupId': 'OG000'}, {'value': '38.9', 'groupId': 'OG001'}]}]}, {'title': '4 to 12 hours (Cycle 3)', 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000'}, {'value': '58.4', 'groupId': 'OG001'}]}]}, {'title': 'More than 12 hours (Cycle 3)', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Missing (Cycle 3)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Less than 30 minutes (Cycle 4)', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '30 minutes to 1 hour (Cycle 4)', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '1 to 2 hours (Cycle 4)', 'categories': [{'measurements': [{'value': '21.8', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': '2 to 4 hours (Cycle 4)', 'categories': [{'measurements': [{'value': '55.0', 'groupId': 'OG000'}, {'value': '36.7', 'groupId': 'OG001'}]}]}, {'title': '4 to 12 hours (Cycle 4)', 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000'}, {'value': '60.6', 'groupId': 'OG001'}]}]}, {'title': 'More than 12 hours (Cycle 4)', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Missing (Cycle 4)', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Less than 30 minutes (Cycle 5)', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}]}]}, {'title': '30 minutes to 1 hour (Cycle 5)', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '1 to 2 hours (Cycle 5)', 'categories': [{'measurements': [{'value': '25.2', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': '2 to 4 hours (Cycle 5)', 'categories': [{'measurements': [{'value': '53.4', 'groupId': 'OG000'}, {'value': '40.2', 'groupId': 'OG001'}]}]}, {'title': '4 to 12 hours (Cycle 5)', 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000'}, {'value': '56.3', 'groupId': 'OG001'}]}]}, {'title': 'More than 12 hours (Cycle 5)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Missing (Cycle 5)', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Less than 30 minutes (Cycle 6)', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}]}]}, {'title': '30 minutes to 1 hour (Cycle 6)', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '1 to 2 hours (Cycle 6)', 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': '2 to 4 hours (Cycle 6)', 'categories': [{'measurements': [{'value': '56.7', 'groupId': 'OG000'}, {'value': '42.5', 'groupId': 'OG001'}]}]}, {'title': '4 to 12 hours (Cycle 6)', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}, {'value': '53.3', 'groupId': 'OG001'}]}]}, {'title': 'More than 12 hours (Cycle 6)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Missing (Cycle 6)', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Less than 30 minutes (Cycle 7)', 'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '30 minutes to 1 hour (Cycle 7)', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '1 to 2 hours (Cycle 7)', 'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000'}, {'value': '4.9', 'groupId': 'OG001'}]}]}, {'title': '2 to 4 hours (Cycle 7)', 'categories': [{'measurements': [{'value': '40.2', 'groupId': 'OG000'}, {'value': '48.8', 'groupId': 'OG001'}]}]}, {'title': '4 to 12 hours (Cycle 7)', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000'}, {'value': '44.4', 'groupId': 'OG001'}]}]}, {'title': 'More than 12 hours (Cycle 7)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Missing (Cycle 7)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Less than 30 minutes (Cycle 8)', 'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}]}]}, {'title': '30 minutes to 1 hour (Cycle 8)', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '1 to 2 hours (Cycle 8)', 'categories': [{'measurements': [{'value': '29.3', 'groupId': 'OG000'}, {'value': '4.4', 'groupId': 'OG001'}]}]}, {'title': '2 to 4 hours (Cycle 8)', 'categories': [{'measurements': [{'value': '36.7', 'groupId': 'OG000'}, {'value': '50.9', 'groupId': 'OG001'}]}]}, {'title': '4 to 12 hours (Cycle 8)', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}, {'value': '43.4', 'groupId': 'OG001'}]}]}, {'title': 'More than 12 hours (Cycle 8)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Missing (Cycle 8)', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)', 'description': 'Chair time was defined as the amount of time the participant occupied an infusion chair/bed for a single treatment cycle of rituximab + CHOP chemotherapy. Where the chair time was not documented for a given cycle, it was reported as "Missing".', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab SC', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}, {'id': 'OG001', 'title': 'Rituximab IV', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}], 'classes': [{'title': 'Less than 2 hours (Cycle 1)', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '2 to 4 hours (Cycle 1)', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}]}]}, {'title': '4 to 6 hours (Cycle 1)', 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000'}, {'value': '20.7', 'groupId': 'OG001'}]}]}, {'title': '6 to 12 hours (Cycle 1)', 'categories': [{'measurements': [{'value': '39.0', 'groupId': 'OG000'}, {'value': '43.8', 'groupId': 'OG001'}]}]}, {'title': '12 to 24 hours (Cycle 1)', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}, {'value': '6.9', 'groupId': 'OG001'}]}]}, {'title': 'More than 24 hours (Cycle 1)', 'categories': [{'measurements': [{'value': '26.8', 'groupId': 'OG000'}, {'value': '24.1', 'groupId': 'OG001'}]}]}, {'title': 'Missing (Cycle 1)', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'Less than 2 hours (Cycle 2)', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '2 to 4 hours (Cycle 2)', 'categories': [{'measurements': [{'value': '33.1', 'groupId': 'OG000'}, {'value': '10.1', 'groupId': 'OG001'}]}]}, {'title': '4 to 6 hours (Cycle 2)', 'categories': [{'measurements': [{'value': '27.9', 'groupId': 'OG000'}, {'value': '33.5', 'groupId': 'OG001'}]}]}, {'title': '6 to 12 hours (Cycle 2)', 'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000'}, {'value': '38.8', 'groupId': 'OG001'}]}]}, {'title': '12 to 24 hours (Cycle 2)', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'More than 24 hours (Cycle 2)', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}, {'value': '11.7', 'groupId': 'OG001'}]}]}, {'title': 'Missing (Cycle 2)', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '4.8', 'groupId': 'OG001'}]}]}, {'title': 'Less Than 2 hours (Cycle 3)', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}]}]}, {'title': '2 to 4 hours (Cycle 3)', 'categories': [{'measurements': [{'value': '37.2', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}]}]}, {'title': '4 to 6 hours (Cycle 3)', 'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000'}, {'value': '30.8', 'groupId': 'OG001'}]}]}, {'title': '6 to 12 hours (Cycle 3)', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000'}, {'value': '41.6', 'groupId': 'OG001'}]}]}, {'title': '12 to 24 hours (Cycle 3)', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'More than 24 hours (Cycle 3)', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '10.3', 'groupId': 'OG001'}]}]}, {'title': 'Missing (Cycle 3)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Less Than 2 hours (Cycle 4)', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '2 to 4 hours (Cycle 4)', 'categories': [{'measurements': [{'value': '36.3', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}]}]}, {'title': '4 to 6 hours (Cycle 4)', 'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000'}, {'value': '31.1', 'groupId': 'OG001'}]}]}, {'title': '6 to 12 hours (Cycle 4)', 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}, {'value': '42.2', 'groupId': 'OG001'}]}]}, {'title': '12 to 24 hours (Cycle 4)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'More than 24 hours (Cycle 4)', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}, {'value': '10.6', 'groupId': 'OG001'}]}]}, {'title': 'Missing (Cycle 4)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'Less Than 2 hours (Cycle 5)', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}]}]}, {'title': '2 to 4 hours (Cycle 5)', 'categories': [{'measurements': [{'value': '39.5', 'groupId': 'OG000'}, {'value': '11.5', 'groupId': 'OG001'}]}]}, {'title': '4 to 6 hours (Cycle 5)', 'categories': [{'measurements': [{'value': '26.4', 'groupId': 'OG000'}, {'value': '34.5', 'groupId': 'OG001'}]}]}, {'title': '6 to 12 hours (Cycle 5)', 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000'}, {'value': '37.4', 'groupId': 'OG001'}]}]}, {'title': '12 to 24 hours (Cycle 5)', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'More than 24 hours (Cycle 5)', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}, {'value': '10.9', 'groupId': 'OG001'}]}]}, {'title': 'Missing (Cycle 5)', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'Less Than 2 hours (Cycle 6)', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}]}]}, {'title': '2 to 4 hours (Cycle 6)', 'categories': [{'measurements': [{'value': '39.6', 'groupId': 'OG000'}, {'value': '12.6', 'groupId': 'OG001'}]}]}, {'title': '4 to 6 hours (Cycle 6)', 'categories': [{'measurements': [{'value': '26.4', 'groupId': 'OG000'}, {'value': '34.1', 'groupId': 'OG001'}]}]}, {'title': '6 to 12 hours (Cycle 6)', 'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000'}, {'value': '38.3', 'groupId': 'OG001'}]}]}, {'title': '12 to 24 hours (Cycle 6)', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'More than 24 hours (Cycle 6)', 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000'}, {'value': '9.0', 'groupId': 'OG001'}]}]}, {'title': 'Missing (Cycle 6)', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'Less Than 2 hours (Cycle 7)', 'categories': [{'measurements': [{'value': '17.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '2 to 4 hours (Cycle 7)', 'categories': [{'measurements': [{'value': '40.8', 'groupId': 'OG000'}, {'value': '23.5', 'groupId': 'OG001'}]}]}, {'title': '4 to 6 hours (Cycle 7)', 'categories': [{'measurements': [{'value': '19.9', 'groupId': 'OG000'}, {'value': '36.4', 'groupId': 'OG001'}]}]}, {'title': '6 to 12 hours (Cycle 7)', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000'}, {'value': '30.9', 'groupId': 'OG001'}]}]}, {'title': '12 to 24 hours (Cycle 7)', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'More than 24 hours (Cycle 7)', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}, {'value': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'Missing (Cycle 7)', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Less Than 2 hours (Cycle 8)', 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '2 to 4 hours (Cycle 8)', 'categories': [{'measurements': [{'value': '40.5', 'groupId': 'OG000'}, {'value': '25.8', 'groupId': 'OG001'}]}]}, {'title': '4 to 6 hours (Cycle 8)', 'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000'}, {'value': '34.0', 'groupId': 'OG001'}]}]}, {'title': '6 to 12 hours (Cycle 8)', 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000'}, {'value': '30.8', 'groupId': 'OG001'}]}]}, {'title': '12 to 24 hours (Cycle 8)', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'More than 24 hours (Cycle 8)', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}]}]}, {'title': 'Missing (Cycle 8)', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)', 'description': 'Hospital time was defined as the amount of time the participant was in the hospital for the course of one cycle of rituximab + CHOP chemotherapy. Where the hospital time was not documented for a given cycle, it was reported as "Missing".', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Event-Free Survival (EFS) Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab SC', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}, {'id': 'OG001', 'title': 'Rituximab IV', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}], 'classes': [{'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 4.25 years', 'description': 'EFS events included disease progression, relapse, initiation of other anti-lymphoma therapy, or death. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as greater than or equal to (≥) 50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \\>1 cm, following an earlier assessment of CR or CRu.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Duration of EFS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab SC', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}, {'id': 'OG001', 'title': 'Rituximab IV', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median EFS was not reached.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median EFS was not reached.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 4.25 years', 'description': 'EFS was defined as the time from randomization to first occurrence of disease progression, relapse, initiation of other anti-lymphoma therapy, or death, whichever occurred first. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as a ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \\>1 cm, following an earlier assessment of CR or CRu.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Relapse or Death at the Time of Primary Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab SC', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}, {'id': 'OG001', 'title': 'Rituximab IV', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 2 years (assessed at Baseline, Day 1 of each cycle [maximum 8 cycles; each cycle was 14 or 21 days], every 3 months thereafter, and/or 4 weeks after early termination)', 'description': 'Tumor response was assessed according to criteria published by Cheson et al (1999). Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \\>1 cm, following an earlier assessment of CR or CRu. The number of participants who had experienced relapse or death prior to the clinical cut-off date (October 2014) was determined.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (Responder Subpopulation): All participants who achieved CR or CRu after 4 cycles.'}, {'type': 'SECONDARY', 'title': 'Duration of Disease-Free Survival (DFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab SC', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}, {'id': 'OG001', 'title': 'Rituximab IV', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median DFS was not reached.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median DFS was not reached.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 4.25 years', 'description': 'DFS was defined as the time from date of initial CR/CRu to the date of relapse or death from any cause. Tumor response was assessed according to criteria published by Cheson et al (1999). Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \\>1 cm, following an earlier assessment of CR or CRu.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (Responder Subpopulation).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Progression, Relapse, or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab SC', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}, {'id': 'OG001', 'title': 'Rituximab IV', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}], 'classes': [{'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 4.25 years', 'description': 'Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \\>1 cm, following an earlier assessment of CR or CRu.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Duration of Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab SC', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}, {'id': 'OG001', 'title': 'Rituximab IV', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median PFS was not reached.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median PFS was not reached.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 4.25 years', 'description': 'PFS was defined as the time from randomization to first occurrence of disease progression, relapse, or death from any cause. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \\>1 cm, following an earlier assessment of CR or CRu.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Number of Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab SC', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}, {'id': 'OG001', 'title': 'Rituximab IV', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 4.25 years', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Duration of Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab SC', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}, {'id': 'OG001', 'title': 'Rituximab IV', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median OS was not reached.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median OS was not reached.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 4.25 years', 'description': 'OS was defined as the time from randomization to death from any cause.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rituximab Subcutaneous (SC)', 'description': 'Participants with previously untreated, cluster of differentiation (CD) 20-positive diffuse large B-cell lymphoma (DLBCL) received up to 8 cycles of rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 milligrams per meter-squared (mg/m\\^2) via IV infusion; subsequent doses were given as 1400 milligrams (mg) via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved complete response (CR) or complete response unconfirmed (CRu) after 4 cycles, but all participants received a full 8 cycles of rituximab.'}, {'id': 'FG001', 'title': 'Rituximab Intravenous (IV)', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '369'}, {'groupId': 'FG001', 'numSubjects': '203'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}, {'groupId': 'FG001', 'numSubjects': '125'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '139'}, {'groupId': 'FG001', 'numSubjects': '78'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Treatment Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Stable or Progressed Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Lack of Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': 'A total of 662 individuals were screened for entry into the study, and 86 failed the screening procedure. Overall, 576 participants were randomized; 572 received treatment and were included in the analyses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '572', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rituximab SC', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}, {'id': 'BG001', 'title': 'Rituximab IV', 'description': 'Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.4', 'spread': '13.78', 'groupId': 'BG000'}, {'value': '61.0', 'spread': '12.63', 'groupId': 'BG001'}, {'value': '60.6', 'spread': '13.38', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '265', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '204', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Population: All participants who received at least one dose of study drug according to treatment received.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 572}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-11', 'studyFirstSubmitDate': '2012-07-23', 'resultsFirstSubmitDate': '2016-01-15', 'studyFirstSubmitQcDate': '2012-07-23', 'lastUpdatePostDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-01-15', 'studyFirstPostDateStruct': {'date': '2012-07-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu)', 'timeFrame': 'Up to approximately 4.25 years', 'description': 'Tumor response was assessed per criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by greater than (\\>) 75 percent (%) but still \\>1.5 centimeters (cm) in size, and indeterminate bone marrow assessment. The percentage of participants with either response at the end of induction (EOI) was determined with corresponding 95% Pearson-Clopper confidence interval (CI).'}], 'secondaryOutcomes': [{'measure': 'Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores', 'timeFrame': 'At Cycle 7 (each cycle was 14 or 21 days)', 'description': 'The CTSQ is a validated 16-item questionnaire that measures three domains related to satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.'}, {'measure': 'Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores', 'timeFrame': 'At Cycle 7 (each cycle was 14 or 21 days)', 'description': 'The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.'}, {'measure': 'Median Duration of Rituximab Administration for Each Treatment Cycle', 'timeFrame': 'Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)', 'description': 'Duration of rituximab administration was defined as the time from start to end of the SC injection or IV infusion. The median duration was reported.'}, {'measure': 'Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle', 'timeFrame': 'Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)', 'description': 'Chair time was defined as the amount of time the participant occupied an infusion chair/bed for a single treatment cycle of rituximab + CHOP chemotherapy. Where the chair time was not documented for a given cycle, it was reported as "Missing".'}, {'measure': 'Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle', 'timeFrame': 'Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)', 'description': 'Hospital time was defined as the amount of time the participant was in the hospital for the course of one cycle of rituximab + CHOP chemotherapy. Where the hospital time was not documented for a given cycle, it was reported as "Missing".'}, {'measure': 'Number of Participants With an Event-Free Survival (EFS) Event', 'timeFrame': 'Up to approximately 4.25 years', 'description': 'EFS events included disease progression, relapse, initiation of other anti-lymphoma therapy, or death. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as greater than or equal to (≥) 50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \\>1 cm, following an earlier assessment of CR or CRu.'}, {'measure': 'Duration of EFS', 'timeFrame': 'Up to approximately 4.25 years', 'description': 'EFS was defined as the time from randomization to first occurrence of disease progression, relapse, initiation of other anti-lymphoma therapy, or death, whichever occurred first. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as a ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \\>1 cm, following an earlier assessment of CR or CRu.'}, {'measure': 'Number of Participants With Relapse or Death at the Time of Primary Analysis', 'timeFrame': 'Up to approximately 2 years (assessed at Baseline, Day 1 of each cycle [maximum 8 cycles; each cycle was 14 or 21 days], every 3 months thereafter, and/or 4 weeks after early termination)', 'description': 'Tumor response was assessed according to criteria published by Cheson et al (1999). Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \\>1 cm, following an earlier assessment of CR or CRu. The number of participants who had experienced relapse or death prior to the clinical cut-off date (October 2014) was determined.'}, {'measure': 'Duration of Disease-Free Survival (DFS)', 'timeFrame': 'Up to approximately 4.25 years', 'description': 'DFS was defined as the time from date of initial CR/CRu to the date of relapse or death from any cause. Tumor response was assessed according to criteria published by Cheson et al (1999). Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \\>1 cm, following an earlier assessment of CR or CRu.'}, {'measure': 'Number of Participants With Progression, Relapse, or Death', 'timeFrame': 'Up to approximately 4.25 years', 'description': 'Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \\>1 cm, following an earlier assessment of CR or CRu.'}, {'measure': 'Duration of Progression-Free Survival (PFS)', 'timeFrame': 'Up to approximately 4.25 years', 'description': 'PFS was defined as the time from randomization to first occurrence of disease progression, relapse, or death from any cause. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \\>1 cm, following an earlier assessment of CR or CRu.'}, {'measure': 'Number of Deaths', 'timeFrame': 'Up to approximately 4.25 years'}, {'measure': 'Duration of Overall Survival (OS)', 'timeFrame': 'Up to approximately 4.25 years', 'description': 'OS was defined as the time from randomization to death from any cause.'}]}, 'conditionsModule': {'conditions': ['Lymphoma, Large B-Cell, Diffuse']}, 'referencesModule': {'references': [{'pmid': '28935843', 'type': 'DERIVED', 'citation': 'Lugtenburg P, Avivi I, Berenschot H, Ilhan O, Marolleau JP, Nagler A, Rueda A, Tani M, Turgut M, Osborne S, Smith R, Pfreundschuh M. Efficacy and safety of subcutaneous and intravenous rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in first-line diffuse large B-cell lymphoma: the randomized MabEase study. Haematologica. 2017 Nov;102(11):1913-1922. doi: 10.3324/haematol.2017.173583. Epub 2017 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'This multicenter, randomized, open label parallel-group study will evaluate the efficacy and safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8 cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study treatment is 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 18 and \\</= 80 years of age at time of study inclusion\n* Histologically confirmed, previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL) according to the WHO classification system\n* Patients with an International Prognostic Index (IPI) score 1-5, or IPI score 0 with bulky disease, defined as one lesion \\>/= 7.5 cm\n* At least one bi-dimensionally measurable lesion defined as \\>/= 1.5 cm in its largest dimension on CT scan, PET-CT scan or MRI\n* Adequate hematologic function\n* Eastern Cooperative Oncology Group (EOCD) performance status \\</= 2\n\nExclusion Criteria:\n\n* Primary or secondary central nervous system lymphoma, histologic evidence of transformation to Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, primary cutaneous DLBCL, or primary DLBCL of the testis\n* Transformed lymphoma or follicular lymphoma IIIB\n* Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation\n* History of other malignancy, except for curatively treated basal or squamous cell carcinoma or melanoma of the skin, carcinoma in situ of the cervix, or a malignancy that has been treated without curative intent and has been in remission without treatment for \\>/= 5 years prior to enrolment\n* Inadequate renal or hepatic function\n* Known human immunodeficiency virus (HIV) infection or HIV seropositive status\n* Active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection. Patients with occult or prior HBV infection as defined by protocol may be included. Patients positive for HCV antibody are eligible only if polymerase chain reaction testing for HCV ribonucleic acid is negative.\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products\n* Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines\n* Prior treatment with cytotoxic drugs or rituximab for another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT01649856', 'briefTitle': 'A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Comparative, Randomized, Parallel-group, Multi-center, Phase IIIB Study to Investigate the Efficacy of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL)', 'orgStudyIdInfo': {'id': 'MO28107'}, 'secondaryIdInfos': [{'id': '2012-000669-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A: Rituximab SC', 'interventionNames': ['Drug: CHOP', 'Drug: rituximab [MabThera/Rituxan]']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B: Rituximab IV', 'interventionNames': ['Drug: CHOP', 'Drug: rituximab [MabThera/Rituxan]']}], 'interventions': [{'name': 'CHOP', 'type': 'DRUG', 'description': 'CHOP chemotherapy: cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone; 6 or 8 cycles', 'armGroupLabels': ['A: Rituximab SC', 'B: Rituximab IV']}, {'name': 'rituximab [MabThera/Rituxan]', 'type': 'DRUG', 'description': 'The first rituximab dose will be administered intravenously on Day of Cycle 1 at a dose of 375 mg/m2. Subsequent doses of 1400 mg are administered subcutaneously on Day 1 of each cycle, for a further 7 cycles', 'armGroupLabels': ['A: Rituximab SC']}, {'name': 'rituximab [MabThera/Rituxan]', 'type': 'DRUG', 'description': '375 mg/m2 intravenously on Day 1 of each cycle, 8 cycles', 'armGroupLabels': ['B: Rituximab IV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09000', 'city': 'Blida', 'country': 'Algeria', 'facility': 'EHS CAC Hospital FRANTZ FANON ZABANA BLIDA; Hematology ward', 'geoPoint': {'lat': 36.47004, 'lon': 2.8277}}, {'zip': '15000', 'city': 'Tizi Ouzou', 'country': 'Algeria', 'facility': "Centre hospitalo-univerisitaire de Tizi Ouzou - Nedir Mohamed;Service d'hématologie", 'geoPoint': {'lat': 36.71182, 'lon': 4.04591}}, {'zip': 'C1431FWO', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Cemic; Haematology', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '7600', 'city': 'Mar del Plata', 'country': 'Argentina', 'facility': 'Hospital Privado de Comunidad; Oncology', 'geoPoint': {'lat': -38.00042, 'lon': -57.5562}}, {'zip': '9300', 'city': 'Aalst', 'country': 'Belgium', 'facility': 'Onze Lieve Vrouwziekenhuis Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'ZNA Middelheim', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Brugmann (Victor Horta)', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Clin Univ de Bxl Hôpital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '6000', 'city': 'Charleroi', 'country': 'Belgium', 'facility': 'CHU Charleroi-ISPPC-Espace Santé', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '6000', 'city': 'Charleroi', 'country': 'Belgium', 'facility': 'CHU de Charleroi', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '6000', 'city': 'Charleroi', 'country': 'Belgium', 'facility': 'GHdC Site Notre Dame', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3500', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Jessa Zkh (Campus Virga Jesse)', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': '2300', 'city': 'Turnhout', 'country': 'Belgium', 'facility': 'AZ Turnhout Sint Elisabeth', 'geoPoint': {'lat': 51.32254, 'lon': 4.94471}}, {'zip': '4800', 'city': 'Verviers', 'country': 'Belgium', 'facility': 'CHR de Verviers - East Belgium', 'geoPoint': {'lat': 50.58907, 'lon': 5.86241}}, {'zip': '60336-550', 'city': 'Fortaleza', 'state': 'Ceará', 'country': 'Brazil', 'facility': 'Crio - Centro Regional Integrado de Oncologia', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'zip': '20560-120', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Instituto Nacional de Cancer - INCa; Oncologia', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '22290-160', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Clinicas Oncologicas Integradas - COI', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '90470340', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Giovanni Battista - Mae de Deus Center; Instituto do Cancer', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '17210-080', 'city': 'Jaú', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Amaral Carvalho', 'geoPoint': {'lat': -22.29639, 'lon': -48.55778}}, {'zip': '05403-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clinicas - FMUSP; Hematologia', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '4002', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'University Hospital Sv.Georgi Clnic of Hematology; Hematology', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Military Medical Academy; Hematology And Oncology', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'UMHAT Alexandrovska EAD; Hematology', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': 'V7L 2L7', 'city': 'North Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "Lion'S Gate Hospital", 'geoPoint': {'lat': 49.31636, 'lon': -123.06934}}, {'zip': 'R3E 0V9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Cancer Care Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'E1C 8X3', 'city': 'Moncton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Regional health authority A vitalite health network', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}, {'zip': 'L4M 6M2', 'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'zip': 'L6R 3J7', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'William Osler Health System Brampton Civic Hospital', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'N2G 1G3', 'city': 'Kitchener', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Grand River Regional Cancer Centre', 'geoPoint': {'lat': 43.42537, 'lon': -80.5112}}, {'zip': 'L3Y 2P9', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Southlake Regional Health Center; 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