Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-04-16 @ 1:07 PM
Study NCT ID:
NCT02406092
Status:
COMPLETED
Last Update Posted:
2024-11-21
First Post:
2015-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Study of Rituximab (SC) Administered in Participants With CD20+ DLBCL or CD20+ Follicular NHL Grade 1 to 3A
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'C024352', 'term': 'fludarabine'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffman-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])', 'eventGroups': [{'id': 'EG000', 'title': 'DLBCL Arm', 'description': 'Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.', 'otherNumAtRisk': 95, 'deathsNumAtRisk': 95, 'otherNumAffected': 58, 'seriousNumAtRisk': 95, 'deathsNumAffected': 22, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'FL Arm', 'description': 'Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 12, 'seriousNumAtRisk': 27, 'deathsNumAffected': 5, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 91, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 13, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 24, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Mucosal Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Oral Herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}], 'seriousEvents': [{'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Blood and'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Bone Marrow Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Cardiac Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Rectal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Mucosal Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Abscess Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Candida Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Hepatitis B Reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Klebsiella Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Fibula Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Liver Function Test Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Generalised Tonic-Clonic Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Haemorrhagic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Administration-Associated Reactions (AARs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DLBCL Arm', 'description': 'Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.'}, {'id': 'OG001', 'title': 'FL Arm', 'description': 'Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.'}, {'id': 'OG002', 'title': 'Overall Population', 'description': 'All participants will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.'}], 'classes': [{'title': 'Blood And Lymphatic System Disorders, And Lymphatic System Disorders, Anaemia', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '3.7', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}]}]}, {'title': 'Blood And Lymphatic System Disorders, Leukopenia', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Blood And Lymphatic System Disorders, Thrombocytopenia', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'General Disorders And Administration Site Conditions, Injection Site Erythema', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '7.4', 'groupId': 'OG001'}, {'value': '4.9', 'groupId': 'OG002'}]}]}, {'title': 'General Disorders And Administration Site Conditions, Injection Site, Injection Site Pain', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3.3', 'groupId': 'OG002'}]}]}, {'title': 'Nervous System Disorders, Burning Sensation', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}]}]}, {'title': 'Nervous System Disorders, Paraesthesia', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Skin And Subcutaneous Tissue Disorders, Erythema', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}]}]}, {'title': 'Skin And Subcutaneous Tissue Disorders, Dermatitis Allergic', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 24 hours of each rituximab SC administration (maximum treatment duration up to 32 months for FL participants and up to 8 months for DLBCL participants)', 'description': 'AARs defined as all related adverse events (AEs) occurring within 24 hours of rituximab SC administration, including infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof.', 'unitOfMeasure': 'Percentage of Participants %', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Event-Free Survival (EFS) as Assessed by Investigator According to International Working Group (IWG) Response Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DLBCL Arm', 'description': 'Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.'}, {'id': 'OG001', 'title': 'FL Arm', 'description': 'Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.'}, {'id': 'OG002', 'title': 'Overall', 'description': 'All participants received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.'}], 'classes': [{'title': 'From first dose of rituximab IV', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '33.4', 'upperLimit': 'NA'}, {'value': '53.8', 'comment': 'The upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '32.6', 'upperLimit': 'NA'}, {'value': '53.8', 'comment': 'The upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.', 'groupId': 'OG002', 'lowerLimit': '38.4', 'upperLimit': 'NA'}]}]}, {'title': 'From first dose of rituximab SC', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '32.7', 'upperLimit': 'NA'}, {'value': '45.5', 'comment': 'The upper limit of 95% CI was not evaluable due to an insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '25.1', 'upperLimit': 'NA'}, {'value': '45.5', 'comment': 'The upper limit of 95% CI was not evaluable due to an insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': '33.5', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of rituximab intravenous (IV) and SC until first occurrence of progression or relapse (up to end of induction treatment [Up to 53.8 Months])', 'description': 'EFS is defined as the time from first dose of rituximab (analysed using both first dose of IV and first dose of SC) to first occurrence of progression or relapse, according to the IWG response criteria or other country standards, or initiation of a non-protocolspecified anti-lymphoma therapy or death, whichever occurs first.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS) as Assessed by Investigator According to IWG Response Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DLBCL Arm', 'description': 'Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.'}, {'id': 'OG001', 'title': 'FL Arm', 'description': 'Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.'}, {'id': 'OG002', 'title': 'Overall Population', 'description': 'Participants received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction'}], 'classes': [{'title': 'From first dose of rituximab IV', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '33.4', 'upperLimit': 'NA'}, {'value': '53.8', 'comment': 'The upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '32.6', 'upperLimit': 'NA'}, {'value': '53.8', 'comment': 'The upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.', 'groupId': 'OG002', 'lowerLimit': '38.4', 'upperLimit': 'NA'}]}]}, {'title': 'From first dose of rituximab SC', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '32.7', 'upperLimit': 'NA'}, {'value': '45.5', 'comment': 'The upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '25.1', 'upperLimit': 'NA'}, {'value': '44.5', 'comment': 'The upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.', 'groupId': 'OG002', 'lowerLimit': '35.5', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of rituximab IV and SC until first occurrence of progression or relapse (up to end of induction treatment [Up to 53.8 Months])', 'description': 'PFS is defined as the time from first dose of rituximab (analysed using both first dose of IV and first dose of SC) to the first occurrence of progression or relapse, according to the IWG response criteria (Cheson et al. 1999) or other country standards, or death from any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DLBCL Arm', 'description': 'Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.'}, {'id': 'OG001', 'title': 'FL Arm', 'description': 'Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.'}, {'id': 'OG002', 'title': 'Overall Population', 'description': 'All participants received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.'}], 'classes': [{'title': 'From first dose of rituximab IV', 'categories': [{'measurements': [{'value': '51.4', 'comment': 'The upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '50.4', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median, lower, and upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median, lower, and upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'From first dose of rituximab SC', 'categories': [{'measurements': [{'value': '51.4', 'comment': 'The upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '50.4', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median, lower, and upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median, lower, and upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [Up to 51.1 Months])', 'description': 'OS is defined as the time from first dose of rirtuximab (analysed using both first dose of IV and first dose of SC) until death from any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Disease-Free Survival (DFS) as Assessed by Investigator According to IWG Response Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DLBCL Arm', 'description': 'Participants DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.'}, {'id': 'OG001', 'title': 'FL Arm', 'description': 'Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction'}, {'id': 'OG002', 'title': 'Overall Population', 'description': 'All participants received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median, lower, and upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median and upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '19.7', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median and upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.', 'groupId': 'OG002', 'lowerLimit': '32.7', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of the initial complete response (CR)/complete response unconfirmed (CRu) until date of relapse or death from any cause (up to end of induction treatment [Up to 32.7 Months])', 'description': 'DFS will be assessed at the end of induction treatment in patients achieving CR/CRu and is defined as the period from the date of the initial CR/CRu until the date of relapse or death from any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With CR/CRu as Assessed by Investigator According to IWG Response Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DLBCL Arm', 'description': 'Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.'}, {'id': 'OG001', 'title': 'FL Arm', 'description': 'Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.'}, {'id': 'OG002', 'title': 'Overall Population', 'description': 'All participants received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.2', 'groupId': 'OG000', 'lowerLimit': '63.8', 'upperLimit': '82.9'}, {'value': '76.5', 'groupId': 'OG001', 'lowerLimit': '50.1', 'upperLimit': '93.2'}, {'value': '74.5', 'groupId': 'OG002', 'lowerLimit': '65.1', 'upperLimit': '82.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of rituximab until first occurrence of progression or relapse (up to end of induction treatment [Up to 32 Months])', 'description': "CR/CRu: Response assessments 4 - 6 weeks after the last dose of induction treatment will be based on the Investigator's assessment, completed according to the original International Working Group (IWG) response criteria for response assessment of lymphoma (Cheson et al. 1999).", 'unitOfMeasure': 'Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Healthcare Professional Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Population', 'description': 'Participants with FL and DLBCL will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.'}], 'timeFrame': 'End of treatment (Month 24 for FL participants and Month 8 for DLBCL participants)', 'description': 'Planned Healthcare Professional Questionnaiere was not collected during the study therefore no data to report', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient-Reported Rituximab Administration Questionnaire (RASQ) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DLBCL Arm', 'description': 'Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction'}, {'id': 'OG001', 'title': 'FL Arm', 'description': 'Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction'}, {'id': 'OG002', 'title': 'Overall Population', 'description': 'Participants with FL and DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.5', 'spread': '20.76', 'groupId': 'OG000'}, {'value': '69.2', 'spread': '19.83', 'groupId': 'OG001'}, {'value': '70.2', 'spread': '20.48', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 53.8 Months', 'description': "The RASQ measures the overall participant satisfaction and is a 20-item questionnaire measuring the impact of the treatment administration on 5 domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction.\n\nEach question's answer is chosen from 1 (minimum)-5(maximum score indicating less severity) score range.\n\nFor each domain was scored using the following formula:\n\nDomain score = \\[(Sum of completed item (question) responses / Number of completed items) - 1\\] x 100 / (Maximum possible item response value - Minimum possible item response value)\n\nThe final RASQ domains is calculated using the formula:\n\nRASQ domain score = (Mean of completed item responses - 1) x 25, scores ranging from 1-100 with higher scores indicative of more positive feelings toward therapy. Lower number representing lower satisfaction and higher is the higher satisfaction by the participants.", 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DLBCL Arm', 'description': 'Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.'}, {'id': 'FG001', 'title': 'FL Arm', 'description': 'Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Screen failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Total of 139 participants mentioned below in the table were recruited and enrolled.', 'preAssignmentDetails': '139 participants (105 with DLBCL and 34 with FL) in the intent-to-treat (ITT) population; 122 participants (95 with DLBCL and 27 with FL) in the safety population. From 139 participants, 122 were dosed at least 1 dose were included in Safety Analysis Set.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DLBCL Arm', 'description': 'Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.'}, {'id': 'BG001', 'title': 'FL Arm', 'description': 'Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.3', 'spread': '13.78', 'groupId': 'BG000'}, {'value': '52.8', 'spread': '12.65', 'groupId': 'BG001'}, {'value': '51.7', 'spread': '13.48', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}, {'title': 'Not applicable as per local regulations', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-07', 'size': 6121847, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-06-14T05:21', 'hasProtocol': True}, {'date': '2022-01-04', 'size': 2446429, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-14T05:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2015-03-23', 'resultsFirstSubmitDate': '2022-06-14', 'studyFirstSubmitQcDate': '2015-03-29', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-14', 'studyFirstPostDateStruct': {'date': '2015-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Administration-Associated Reactions (AARs)', 'timeFrame': 'Within 24 hours of each rituximab SC administration (maximum treatment duration up to 32 months for FL participants and up to 8 months for DLBCL participants)', 'description': 'AARs defined as all related adverse events (AEs) occurring within 24 hours of rituximab SC administration, including infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof.'}], 'secondaryOutcomes': [{'measure': 'Event-Free Survival (EFS) as Assessed by Investigator According to International Working Group (IWG) Response Criteria', 'timeFrame': 'From first dose of rituximab intravenous (IV) and SC until first occurrence of progression or relapse (up to end of induction treatment [Up to 53.8 Months])', 'description': 'EFS is defined as the time from first dose of rituximab (analysed using both first dose of IV and first dose of SC) to first occurrence of progression or relapse, according to the IWG response criteria or other country standards, or initiation of a non-protocolspecified anti-lymphoma therapy or death, whichever occurs first.'}, {'measure': 'Progression-Free Survival (PFS) as Assessed by Investigator According to IWG Response Criteria', 'timeFrame': 'From first dose of rituximab IV and SC until first occurrence of progression or relapse (up to end of induction treatment [Up to 53.8 Months])', 'description': 'PFS is defined as the time from first dose of rituximab (analysed using both first dose of IV and first dose of SC) to the first occurrence of progression or relapse, according to the IWG response criteria (Cheson et al. 1999) or other country standards, or death from any cause.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [Up to 51.1 Months])', 'description': 'OS is defined as the time from first dose of rirtuximab (analysed using both first dose of IV and first dose of SC) until death from any cause.'}, {'measure': 'Disease-Free Survival (DFS) as Assessed by Investigator According to IWG Response Criteria', 'timeFrame': 'From the date of the initial complete response (CR)/complete response unconfirmed (CRu) until date of relapse or death from any cause (up to end of induction treatment [Up to 32.7 Months])', 'description': 'DFS will be assessed at the end of induction treatment in patients achieving CR/CRu and is defined as the period from the date of the initial CR/CRu until the date of relapse or death from any cause.'}, {'measure': 'Percentage of Participants With CR/CRu as Assessed by Investigator According to IWG Response Criteria', 'timeFrame': 'From first dose of rituximab until first occurrence of progression or relapse (up to end of induction treatment [Up to 32 Months])', 'description': "CR/CRu: Response assessments 4 - 6 weeks after the last dose of induction treatment will be based on the Investigator's assessment, completed according to the original International Working Group (IWG) response criteria for response assessment of lymphoma (Cheson et al. 1999)."}, {'measure': 'Healthcare Professional Questionnaire Score', 'timeFrame': 'End of treatment (Month 24 for FL participants and Month 8 for DLBCL participants)', 'description': 'Planned Healthcare Professional Questionnaiere was not collected during the study therefore no data to report'}, {'measure': 'Patient-Reported Rituximab Administration Questionnaire (RASQ) Score', 'timeFrame': 'Up to 53.8 Months', 'description': "The RASQ measures the overall participant satisfaction and is a 20-item questionnaire measuring the impact of the treatment administration on 5 domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction.\n\nEach question's answer is chosen from 1 (minimum)-5(maximum score indicating less severity) score range.\n\nFor each domain was scored using the following formula:\n\nDomain score = \\[(Sum of completed item (question) responses / Number of completed items) - 1\\] x 100 / (Maximum possible item response value - Minimum possible item response value)\n\nThe final RASQ domains is calculated using the formula:\n\nRASQ domain score = (Mean of completed item responses - 1) x 25, scores ranging from 1-100 with higher scores indicative of more positive feelings toward therapy. Lower number representing lower satisfaction and higher is the higher satisfaction by the participants."}]}, 'conditionsModule': {'conditions': ['Non-Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': "This open-label, single-arm study will evaluate the safety of rituximab subcutaneously (SC) administered during first line treatment for follicular non-Hodgkin's lymphoma (NHL) (Induction and/or Maintenance treatment plus 24 months of follow up), or diffuse large B-cell lymphoma (DLBCL) (treatment plus 24 months of follow-up)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed, cluster of differentiation (CD)20+ DLBCL or CD20+ follicular NHL grade 1 to 3a, according to the world health organization (WHO) classification system\n* Currently being treated with rituximab IV in the Induction or Maintenance setting, having received at least one full dose of rituximab IV, defined as standard full dose of rituximab IV 375 milligrams per square meter (mg/m\\^2) administered without interruption or early discontinuation because of tolerability issues\n* Expectation and current ability for the participants to receive at least four additional cycles of treatment during the Induction phase or six additional cycles of treatment during the Maintenance phase (participants with follicular NHL)\n\nExclusion Criteria:\n\n* Transformed lymphoma or FL IIIB\n* History of other malignancy that could affect compliance with the protocol or interpretation of results. This includes a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission without treatment for greater than or equal to (\\>/=) 5 years prior to dosing'}, 'identificationModule': {'nctId': 'NCT02406092', 'briefTitle': 'Safety Study of Rituximab (SC) Administered in Participants With CD20+ DLBCL or CD20+ Follicular NHL Grade 1 to 3A', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Open-Label, Multinational, Multicenter, Phase IIIB Study to Assess Safety of Rituximab Following Subcutaneous Administration in Patients With CD20+ DLBCL or CD20+ Follicular NHL Grade 1 to 3A', 'orgStudyIdInfo': {'id': 'ML28964'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rituximab', 'description': 'Participants with FL and DLBCL will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \\[cyclophosphamide+doxorubicin+vincristine+prednisone\\], CVP \\[cyclophosphamide+vincristine+prednisone\\] or FC \\[fludarabine+cyclophosphamide\\]) during induction.', 'interventionNames': ['Drug: Rituximab', 'Drug: Cyclophosphamide', 'Drug: Doxorubicin', 'Drug: Vincristine', 'Drug: Prednisone', 'Drug: Fludarabine']}], 'interventions': [{'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['MabThera®'], 'description': 'Rituximab SC 1400 mg', 'armGroupLabels': ['Rituximab']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Endoxan'], 'description': 'Cyclophosphamide will be administered as per standard local practice.', 'armGroupLabels': ['Rituximab']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'description': 'Doxorubicin will be administered as per standard local practice.', 'armGroupLabels': ['Rituximab']}, {'name': 'Vincristine', 'type': 'DRUG', 'description': 'Vincristine will be administered as per standard local practice.', 'armGroupLabels': ['Rituximab']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': 'Prednisone will be administered as per standard local practice.', 'armGroupLabels': ['Rituximab']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Fludarabine will be administered as per standard local practice.', 'armGroupLabels': ['Rituximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23000', 'city': 'Annaba', 'country': 'Algeria', 'facility': "Hôpital Dorban CHU Annaba, Service d'Hématologie", 'geoPoint': {'lat': 36.9, 'lon': 7.76667}}, {'zip': '09000', 'city': 'Blida', 'country': 'Algeria', 'facility': 'EHS CAC Hospital FRANTZ FANON ZABANA BLIDA; Hematology ward', 'geoPoint': {'lat': 36.47004, 'lon': 2.8277}}, {'zip': '31000', 'city': 'Oran', 'country': 'Algeria', 'facility': "EHU Oran, Service d'Hématologie et de Thérapie Cellulaire", 'geoPoint': {'lat': 35.69906, 'lon': -0.63588}}, {'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': '20100', 'city': 'Casablanca', 'country': 'Morocco', 'facility': "CHU 20 Aout Service D'Onco-Hematologie Pediatrique", 'geoPoint': {'lat': 33.58831, 'lon': -7.61138}}, {'zip': '20340', 'city': 'Casablanca', 'country': 'Morocco', 'facility': 'Clinique AlMadina; Service hematologie', 'geoPoint': {'lat': 33.58831, 'lon': -7.61138}}, {'zip': '40000', 'city': 'Marrakesh', 'country': 'Morocco', 'facility': 'Centre Hospitalier Uni Ire de Marrakech; Oncologie-Hématologie', 'geoPoint': {'lat': 31.63416, 'lon': -7.99994}}, {'zip': '10090', 'city': 'Rabat', 'country': 'Morocco', 'facility': "Hôpital d'enfants de Rabat - Service d'hémato-oncologie pédiatrique", 'geoPoint': {'lat': 34.01325, 'lon': -6.83255}}, {'zip': '5000', 'city': 'Monastir', 'country': 'Tunisia', 'facility': "CHU Fattouma Bourguiba, Monastir; Service d'hématologie", 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}, {'zip': '3025', 'city': 'Sfax', 'country': 'Tunisia', 'facility': "CHU Hédi Chacker; Service d'hématologie", 'geoPoint': {'lat': 34.74056, 'lon': 10.76028}}, {'zip': '4000', 'city': 'Sousse', 'country': 'Tunisia', 'facility': "CHU Farhat Hached; Service d'hématologie", 'geoPoint': {'lat': 35.82539, 'lon': 10.63699}}, {'zip': '1008', 'city': 'Tunis', 'country': 'Tunisia', 'facility': 'Aziza Othmana Hospital; Clinical Haematology', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}, {'zip': '1008', 'city': 'Tunis', 'country': 'Tunisia', 'facility': "Hopital Militaire d'instruction de Tunis; Service d'hématologie", 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}