Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-02-23 @ 1:12 AM
Study NCT ID:
NCT01987505
Status:
COMPLETED
Last Update Posted:
2018-12-26
First Post:
2013-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MabRella Study: A Study to Evaluate the Safety of Switching From Intravenous to Subcutaneous Administration of Rituximab During First-Line Treatment for Lymphoma
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'}], '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-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 start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)', 'description': 'An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Safety Population included all enrolled participants who received at least one dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Subcutaneous Rituximab', 'description': "Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.", 'otherNumAtRisk': 140, 'deathsNumAtRisk': 140, 'otherNumAffected': 117, 'seriousNumAtRisk': 140, 'deathsNumAffected': 4, 'seriousNumAffected': 42}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 36}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Agranulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Paraesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Enterobacter bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Escherichia bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia pneumococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastric neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Administration-Associated Reactions (AARs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diffuse Large B-Cell Lymphoma (DLBCL)', 'description': 'Participants with diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL.'}, {'id': 'OG001', 'title': 'Follicular Lymphoma (FL)', 'description': "Participants with CD20+ non-Hodgkin's follicular lymphoma (FL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Treatment duration was expected to last to 32 months for participants with FL."}, {'id': 'OG002', 'title': 'Subcutaneous Rituximab', 'description': "Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL."}], 'classes': [{'title': 'At Least One AAR', 'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000'}, {'value': '52.3', 'groupId': 'OG001'}, {'value': '48.6', 'groupId': 'OG002'}]}]}, {'title': 'At Least One AAR Grade ≥ 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}, {'value': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'At Least One Serious AARs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Generalised or Remote from the Injection Site AARs', 'categories': [{'measurements': [{'value': '57.9', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '15.1', 'groupId': 'OG002'}]}]}, {'title': 'Localised at the injection site AARs', 'categories': [{'measurements': [{'value': '42.1', 'groupId': 'OG000'}, {'value': '88.9', 'groupId': 'OG001'}, {'value': '84.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of treatment to end of treatment (up to 32 months)', 'description': 'AARs were defined as all adverse events (AEs) occurring within 24 hours of rituximab SC administration and which were considered related to study drug. AARs included infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof. Grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all enrolled participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With At Least One Grade >/= 3 Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diffuse Large B-Cell Lymphoma (DLBCL)', 'description': 'Participants with diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL.'}, {'id': 'OG001', 'title': 'Follicular Lymphoma (FL)', 'description': "Participants with CD20+ non-Hodgkin's follicular lymphoma (FL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Treatment duration was expected to last to 32 months for participants with FL."}, {'id': 'OG002', 'title': 'Subcutaneous Rituximab', 'description': "Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL."}], 'classes': [{'categories': [{'measurements': [{'value': '48.3', 'groupId': 'OG000'}, {'value': '36.0', 'groupId': 'OG001'}, {'value': '38.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)', 'description': 'An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events. Grading was completed according to the CTCAE, version 4.0.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all enrolled participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With At Least One Grade >/= 3 Infusion/ Injection Related Reactions (IIRRs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diffuse Large B-Cell Lymphoma (DLBCL)', 'description': 'Participants with diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL.'}, {'id': 'OG001', 'title': 'Follicular Lymphoma (FL)', 'description': "Participants with CD20+ non-Hodgkin's follicular lymphoma (FL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Treatment duration was expected to last to 32 months for participants with FL."}, {'id': 'OG002', 'title': 'Subcutaneous Rituximab', 'description': "Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL."}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}, {'value': '2.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of treatment to end of treatment (up to 32 months)', 'description': 'Grading of IIRRs was completed according to the CTCAE, version 4.0.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all enrolled participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With At Least One Serious Adverse Event (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diffuse Large B-Cell Lymphoma (DLBCL)', 'description': 'Participants with diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL.'}, {'id': 'OG001', 'title': 'Follicular Lymphoma (FL)', 'description': "Participants with CD20+ non-Hodgkin's follicular lymphoma (FL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Treatment duration was expected to last to 32 months for participants with FL."}, {'id': 'OG002', 'title': 'Subcutaneous Rituximab', 'description': "Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL."}], 'classes': [{'categories': [{'measurements': [{'value': '37.9', 'groupId': 'OG000'}, {'value': '27.9', 'groupId': 'OG001'}, {'value': '30.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)', 'description': 'SAE was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all enrolled participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Event-Free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diffuse Large B-Cell Lymphoma (DLBCL)', 'description': 'Participants with diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL.'}, {'id': 'OG001', 'title': 'Follicular Lymphoma (FL)', 'description': "Participants with CD20+ non-Hodgkin's follicular lymphoma (FL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Treatment duration was expected to last to 32 months for participants with FL."}, {'id': 'OG002', 'title': 'Subcutaneous Rituximab', 'description': "Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL."}], 'classes': [{'categories': [{'measurements': [{'value': '25.79', 'groupId': 'OG000', 'lowerLimit': '20.800', 'upperLimit': '30.776'}, {'value': '54.39', 'groupId': 'OG001', 'lowerLimit': '51.416', 'upperLimit': '57.362'}, {'value': '52.314', 'groupId': 'OG002', 'lowerLimit': '49.162', 'upperLimit': '55.466'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)', 'description': 'EFS was defined as the time from first dose of rituximab IV to first occurrence of progressive disease (PD) or relapse, according to the International Working Group (IWG) response criteria or initiation of a non-protocol-specified anti-lymphoma therapy or death, whichever occurs first. PD: \\>/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population included all enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diffuse Large B-Cell Lymphoma (DLBCL)', 'description': 'Participants with diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL.'}, {'id': 'OG001', 'title': 'Follicular Lymphoma (FL)', 'description': "Participants with CD20+ non-Hodgkin's follicular lymphoma (FL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Treatment duration was expected to last to 32 months for participants with FL."}, {'id': 'OG002', 'title': 'Subcutaneous Rituximab', 'description': "Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL."}], 'classes': [{'categories': [{'measurements': [{'value': '27.952', 'groupId': 'OG000', 'lowerLimit': '23.443', 'upperLimit': '32.460'}, {'value': '54.389', 'groupId': 'OG001', 'lowerLimit': '51.416', 'upperLimit': '57.362'}, {'value': '53.118', 'groupId': 'OG002', 'lowerLimit': '50.108', 'upperLimit': '56.127'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)', 'description': 'PFS was defined as the time from first dose of rituximab IV to the first occurrence of progressive disease (PD) or relapse, according to the International Working Group (IWG) response criteria or death from any cause. PD: \\>/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diffuse Large B-Cell Lymphoma (DLBCL)', 'description': 'Participants with diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL.'}, {'id': 'OG001', 'title': 'Follicular Lymphoma (FL)', 'description': "Participants with CD20+ non-Hodgkin's follicular lymphoma (FL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Treatment duration was expected to last to 32 months for participants with FL."}, {'id': 'OG002', 'title': 'Subcutaneous Rituximab', 'description': "Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL."}], 'classes': [{'categories': [{'measurements': [{'value': '37.42', 'groupId': 'OG000', 'lowerLimit': '33.354', 'upperLimit': '41.485'}, {'value': '60.61', 'groupId': 'OG001', 'lowerLimit': '59.692', 'upperLimit': '61.535'}, {'value': '59.516', 'groupId': 'OG002', 'lowerLimit': '57.999', 'upperLimit': '61.033'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)', 'description': 'OS was defined as the time from first dose of rituximab IV to death from any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Disease-Free Survival (DFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diffuse Large B-Cell Lymphoma (DLBCL)', 'description': 'Participants with diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL.'}, {'id': 'OG001', 'title': 'Follicular Lymphoma (FL)', 'description': "Participants with CD20+ non-Hodgkin's follicular lymphoma (FL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Treatment duration was expected to last to 32 months for participants with FL."}, {'id': 'OG002', 'title': 'Subcutaneous Rituximab', 'description': "Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL."}], 'classes': [{'categories': [{'measurements': [{'value': '26.062', 'groupId': 'OG000', 'lowerLimit': '23.510', 'upperLimit': '28.613'}, {'value': 'NA', 'comment': 'No events in this arm, therefore mean and 95% Confidence Interval could not be calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '33.044', 'groupId': 'OG002', 'lowerLimit': '31.489', 'upperLimit': '34.600'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)', 'description': 'DFS was assessed in participants achieving complete response (CR) including complete response unconfirmed (Cru) and was defined as the period from the date of the initial CR/CRu until the date of relapse or death from any cause. CR: 1) disappearance of all evidence/symptoms of disease, 2) lymph nodes and nodal masses normal size, 3) enlarged spleen must have regressed in size, 4) normal bone marrow; CRu: see 1) and 3) of CR plus \\> 75% decrease in residual lymph node mass, indeterminate bone marrow. Reported here is the truncated mean estimate based on Kaplan-Meier analysis.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Treatment Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diffuse Large B-Cell Lymphoma (DLBCL)', 'description': 'Participants with diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL.'}, {'id': 'OG001', 'title': 'Follicular Lymphoma (FL)', 'description': "Participants with CD20+ non-Hodgkin's follicular lymphoma (FL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Treatment duration was expected to last to 32 months for participants with FL."}, {'id': 'OG002', 'title': 'Subcutaneous Rituximab', 'description': "Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL."}], 'classes': [{'title': 'Complete Response (CR)', 'categories': [{'measurements': [{'value': '62.1', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '64.3', 'groupId': 'OG002'}]}]}, {'title': 'Complete Response Unconfirmed (CRU)', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '7.4', 'groupId': 'OG001'}, {'value': '5.4', 'groupId': 'OG002'}]}]}, {'title': 'Partial Response (PR)', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '7.1', 'groupId': 'OG002'}]}]}, {'title': 'Stable Disease (SD)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.7', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'Progressive disease (PD)', 'categories': [{'measurements': [{'value': '17.2', 'groupId': 'OG000'}, {'value': '7.4', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}]}]}, {'title': 'Unable to Assess (UA)', 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '3.6', 'groupId': 'OG002'}]}]}, {'title': 'Not Evaluable', 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000'}, {'value': '3.7', 'groupId': 'OG001'}, {'value': '5.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4-6 weeks after the last dose of Induction (Up to approximately 8 months)', 'description': 'Treatment response rate was classified according to the International Working Group (IWG) response criteria: CR/Cru, partial response (PR), stable disease (SD) and PD. CR: 1) disappearance of all evidence/symptoms of disease, 2) lymph nodes and nodal masses normal size, 3) enlarged spleen must have regressed in size, 4) normal bone marrow; CRu: see 1) and 3) of CR plus \\> 75% decrease in residual lymph node mass, indeterminate bone marrow; PR: \\>/= 50% decrease lymph nodes and nodal mass size; decrease in liver/spleen size, no new sites; SD: less than a PR, but is not PD; PD: \\>/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Subcutaneous Rituximab', 'description': "Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab during first-line treatment. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Diffuse Large B-Cell Lymphoma', 'description': 'Participants with diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with DLBCL were administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration was expected to last up to 7 months for participants with DLBCL.'}, {'id': 'BG001', 'title': 'Follicular Lymphoma', 'description': "Participants with CD20+ non-Hodgkin's follicular lymphoma (FL), who had already received at least one full dose of intravenous (IV) rituximab were treated with subcutaneous (SC) rituximab. Participants with FL were administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Treatment duration was expected to last to 32 months for participants with FL."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'spread': '12.0', 'groupId': 'BG000'}, {'value': '59.6', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '60.2', 'spread': '12.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat (ITT) population included all enrolled participants. All analyses described have been performed by type of lymphoma (DLBCL/ FL) and overall.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-05-30', 'size': 5354799, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-04-04T08:53', 'hasProtocol': True}, {'date': '2017-09-11', 'size': 1075462, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-04-04T08:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-04', 'studyFirstSubmitDate': '2013-11-08', 'resultsFirstSubmitDate': '2018-04-04', 'studyFirstSubmitQcDate': '2013-11-13', 'lastUpdatePostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-03', 'studyFirstPostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Administration-Associated Reactions (AARs)', 'timeFrame': 'From start of treatment to end of treatment (up to 32 months)', 'description': 'AARs were defined as all adverse events (AEs) occurring within 24 hours of rituximab SC administration and which were considered related to study drug. AARs included infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof. Grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With At Least One Grade >/= 3 Adverse Events (AEs)', 'timeFrame': 'From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)', 'description': 'An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events. Grading was completed according to the CTCAE, version 4.0.'}, {'measure': 'Percentage of Participants With At Least One Grade >/= 3 Infusion/ Injection Related Reactions (IIRRs)', 'timeFrame': 'From start of treatment to end of treatment (up to 32 months)', 'description': 'Grading of IIRRs was completed according to the CTCAE, version 4.0.'}, {'measure': 'Percentage of Participants With At Least One Serious Adverse Event (SAE)', 'timeFrame': 'From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)', 'description': 'SAE was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.'}, {'measure': 'Event-Free Survival (EFS)', 'timeFrame': 'From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)', 'description': 'EFS was defined as the time from first dose of rituximab IV to first occurrence of progressive disease (PD) or relapse, according to the International Working Group (IWG) response criteria or initiation of a non-protocol-specified anti-lymphoma therapy or death, whichever occurs first. PD: \\>/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)', 'description': 'PFS was defined as the time from first dose of rituximab IV to the first occurrence of progressive disease (PD) or relapse, according to the International Working Group (IWG) response criteria or death from any cause. PD: \\>/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)', 'description': 'OS was defined as the time from first dose of rituximab IV to death from any cause.'}, {'measure': 'Disease-Free Survival (DFS)', 'timeFrame': 'From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)', 'description': 'DFS was assessed in participants achieving complete response (CR) including complete response unconfirmed (Cru) and was defined as the period from the date of the initial CR/CRu until the date of relapse or death from any cause. CR: 1) disappearance of all evidence/symptoms of disease, 2) lymph nodes and nodal masses normal size, 3) enlarged spleen must have regressed in size, 4) normal bone marrow; CRu: see 1) and 3) of CR plus \\> 75% decrease in residual lymph node mass, indeterminate bone marrow. Reported here is the truncated mean estimate based on Kaplan-Meier analysis.'}, {'measure': 'Treatment Response Rate', 'timeFrame': '4-6 weeks after the last dose of Induction (Up to approximately 8 months)', 'description': 'Treatment response rate was classified according to the International Working Group (IWG) response criteria: CR/Cru, partial response (PR), stable disease (SD) and PD. CR: 1) disappearance of all evidence/symptoms of disease, 2) lymph nodes and nodal masses normal size, 3) enlarged spleen must have regressed in size, 4) normal bone marrow; CRu: see 1) and 3) of CR plus \\> 75% decrease in residual lymph node mass, indeterminate bone marrow; PR: \\>/= 50% decrease lymph nodes and nodal mass size; decrease in liver/spleen size, no new sites; SD: less than a PR, but is not PD; PD: \\>/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphoma, Non Hodgkin']}, 'referencesModule': {'references': [{'pmid': '35126524', 'type': 'DERIVED', 'citation': 'Petrini M, Gaidano G, Mengarelli A, Consoli U, Santoro A, Liberati AM, Ladetto M, Fraticelli V, Guarini A, Mannina D, Ferrando P, Corradini P, Musto P, Stelitano C, Marino D, Camera A, Murineddu M, Battistini R, Caparrotti G, Turrini M, Arcaini L, Santini S, Cerqueti M, Ferreri AJM, Cantore N, Inzoli A, Cardinale G, Ronci B, La Nasa G, Massimi S, Gaglione G, Barbiero V, Martelli M. Safety and Efficacy of Subcutaneous Rituximab in Previously Untreated Patients with CD20+ Diffuse Large B-Cell Lymphoma or Follicular Lymphoma: Results from an Italian Phase IIIb Study. Adv Hematol. 2022 Jan 27;2022:5581772. doi: 10.1155/2022/5581772. eCollection 2022.'}, {'pmid': '31573078', 'type': 'DERIVED', 'citation': 'Garcia-Munoz R, Quero C, Perez-Persona E, Domingo-Garcia A, Perez-Lopez C, Villaescusa-de-la-Rosa T, Martinez-Castro AM, Arguinano-Perez JM, Parra-Cuadrado JF, Panizo C. Safety of switching from intravenous to subcutaneous rituximab during first-line treatment of patients with non-Hodgkin lymphoma: the Spanish population of the MabRella study. Br J Haematol. 2020 Mar;188(5):661-673. doi: 10.1111/bjh.16227. Epub 2019 Oct 1.'}]}, 'descriptionModule': {'briefSummary': "This open-label, single-arm, phase IIIb study will evaluate the safety of switching from intravenous (IV) to subcutaneous (SC) administration of rituximab during first-line treatment for participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) who have already received at least one full dose of rituximab IV. Participants with FL will be given 1400 mg rituximab SC during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). 1400 mg SC of rituximab will be given to participants with DLBCL once monthly for 4-7 cycles. Treatment duration is expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 and ≤ 80 years at time of enrolment.\n* Life expectancy ≥ 6 months.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.\n* Fertile men or women of childbearing potential must use effective contraception until at least 12 months after the last dose; women must not be pregnant.\n* Histologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL) or CD20+ follicular Non-Hodgkin Lymphoma (FL) grade 1, 2 or 3a according to the World Health Organisation Classification system.\n\nInduction only:\n\n* Participants with Follicular Lymphoma should meet Groupe D'Etude des Lymphomes Folliculaires (GELF) criteria to initiate treatment.\n* At least tumor \\>/= 1.5 cm as measured by computed tomography (CT) scan.\n\nFL treatment-related criteria\n\n\\- Currently being treated with rituximab IV during first-line therapy and has received at least one full dose of rituximab IV.\n\nExclusion Criteria:\n\n* Transformed lymphoma.\n* Primary central nervous system lymphoma, primary effusion lymphoma, primary mediastinal DLBCL, DLBCL of the testis, primary cutaneous DLBCL or histologic evidence of transformation to a Burkitt lymphoma.\n* History of other cancer, including one that has been treated but not with curative intent, unless the cancer has been in remission without treatment for \\>/= 5 years prior to dosing. Note: Participants with a history of cured skin cancer or in situ carcinoma of the cervix are eligible for the study.\n* Ongoing corticosteroid use \\> 30 mg/day of prednisone or equivalent. Note: Participants receiving corticosteroid treatment with \\</= 30 mg/day of prednisone or equivalent must be on a stable regimen for at least 4 weeks prior to start of dosing.\n* Inadequate renal, hematologic, or hepatic function.\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products.\n* For participants with DLBCL: Contraindication to any of the individual components of CHOP (cyclophosphamide, vincristine, doxorubicin and prednisone), including prior anthracycline treatment.\n* For participants with FL: contraindication to standard chemotherapy.\n* Other serious underlying medical conditions.\n* Recent major surgery (within 4 weeks prior to dosing), other than for diagnosis.\n* Active and/or severe infections (excluding nail fungal infections) or any infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to dosing.\n* Active Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection. Note: Participants testing positive for Hepatitis B or C virus antibodies but with an undetectable viral load may be included.\n* History of Human Immunodeficiency Virus (HIV) positive status."}, 'identificationModule': {'nctId': 'NCT01987505', 'briefTitle': 'MabRella Study: A Study to Evaluate the Safety of Switching From Intravenous to Subcutaneous Administration of Rituximab During First-Line Treatment for Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': "Open Label, Single-arm, Phase IIIb Clinical Trial to Evaluate the Safety of Switching From Intravenous Rituximab to Subcutaneous Rituximab During First Line Treatment for CD20+ Non-Hodgkin's Follicular Lymphoma and Diffuse Large B-cell Lymphoma.", 'orgStudyIdInfo': {'id': 'ML28943'}, 'secondaryIdInfos': [{'id': '2013-001118-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subcutaneous Rituximab', 'description': "Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab will be treated with subcutaneous (SC) rituximab. Participants with FL will be administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL will be administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration is expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.", 'interventionNames': ['Drug: Rituximab']}], 'interventions': [{'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['MabThera', 'Rituxan'], 'description': '1400 mg will be injected subcutaneously (SC).', 'armGroupLabels': ['Subcutaneous Rituximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01009', 'city': 'Vitoria-Gasteiz', 'state': 'Alava', 'country': 'Spain', 'facility': 'Hospital De Txagorritxu; Servicio de Hematologia', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}, {'zip': '03600', 'city': 'Elda', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General de Elda; Servicio de Hematologia', 'geoPoint': {'lat': 38.47783, 'lon': -0.79157}}, {'zip': '07198', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'facility': 'Hospital Son Llatzer; Servicio de Hematologia', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '08400', 'city': 'Granollers', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Granollers, Servicio de Hematología', 'geoPoint': {'lat': 41.60797, 'lon': 2.28773}}, {'zip': '08221', 'city': 'Terrassa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Mutua de Terrassa; Servicio de Hematologia', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'zip': '12004', 'city': 'Castellon', 'state': 'Castellon', 'country': 'Spain', 'facility': 'Hospital General de Castellon; Servicio de Hematologia', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}, {'zip': '15006', 'city': 'A Coruña', 'state': 'LA Coruña', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Hematologia', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'LA Coruña', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Hematologia', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '26006', 'city': 'Logroño', 'state': 'La Rioja', 'country': 'Spain', 'facility': 'Complejo Hospitalario San Millan - San Pedro; Servicio Hematologia', 'geoPoint': {'lat': 42.46615, 'lon': -2.45115}}, {'zip': '24008', 'city': 'León', 'state': 'LEON', 'country': 'Spain', 'facility': 'Complejo Asistencial de León, Servicio de Hematología', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'zip': '28943', 'city': 'Fuenlabrada', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario de Fuenlabrada; Servicio de Hematologia', 'geoPoint': {'lat': 40.28419, 'lon': -3.79415}}, {'zip': '28911', 'city': 'Leganés', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Severo Ochoa; Servicio de Hematologia', 'geoPoint': {'lat': 40.32718, 'lon': -3.7635}}, {'zip': '28935', 'city': 'Móstoles', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hosital Universitario de Mostoles;Servicio de Hematologia', 'geoPoint': {'lat': 40.32234, 'lon': -3.86496}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Clinica Universitaria de Navarra; Servicio de Hematologia', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Hospital de Navarra, Servicio de Hematología', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '36204', 'city': 'Vigo', 'state': 'Pontevedra', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de Vigo; Servicio de Hematologia', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'zip': '38010', 'city': 'Santa Cruz de Tenerife', 'state': 'Tenerife', 'country': 'Spain', 'facility': 'Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'zip': '48013', 'city': 'Bilbao', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'Hospital de Basurto; Servicio de Hematologia', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '48960', 'city': 'Galdakao', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'Hospital de Galdakano; Servicio de Hematologia', 'geoPoint': {'lat': 43.23073, 'lon': -2.8429}}, {'zip': '04009', 'city': 'Almería', 'country': 'Spain', 'facility': 'Complejo Hospitalario Torrecardenas; Servicio de Hematologia', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'zip': '09006', 'city': 'Burgos', 'country': 'Spain', 'facility': 'Hospital Universitario de Burgos, Servicio de Hematología', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Hospital Universitario Reina Sofia; Servicio de Hematologia', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '18014', 'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de las Nieves; Servicio de Hematologia', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '19002', 'city': 'Guadalajara', 'country': 'Spain', 'facility': 'Hospital Universitario de Gaudalajara; Hematología', 'geoPoint': {'lat': 40.62862, 'lon': -3.16185}}, {'zip': '25198', 'city': 'Lleida', 'country': 'Spain', 'facility': 'Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Hematologia', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}, {'zip': '28031', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Infanta Leonor; Servicio de Hematologia', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Fundacion Jimenez Diaz; Servicio de Hematologia', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Clínico San Carlos; Servicio de Hematología', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio Hematologia', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28222', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta de Hierro; Servicio de Hematologia', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28805', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Principe de Asturias; Servicio de Hematología', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Univ. Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '30008', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Hospital General Universitario J.M Morales Meseguer; Servicio de Hematología', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '30120', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de Arrixaca; Servicio de Hematologia', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '36071', 'city': 'Pontevedra', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Pontevedra; Servicio de Hematologia', 'geoPoint': {'lat': 42.431, 'lon': -8.64435}}, {'zip': '40002', 'city': 'Segovia', 'country': 'Spain', 'facility': 'Complejo Asistencial de Segovia', 'geoPoint': {'lat': 40.94808, 'lon': -4.11839}}, {'zip': '41009', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Macarena; Servicio de Hematologia', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41014', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Univ. Nuestra Señora de Valme; Servicio de Hematologia', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '47010', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital de Rio Hortega; Servicio de Hematologia', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}