Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-03 @ 4:35 AM
Study NCT ID:
NCT04034056
Status:
COMPLETED
Last Update Posted:
2025-05-09
First Post:
2019-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Untreated FolliculaR Lymphoma Treated With OBinituzumAb in a Non-interventional Study (URBAN)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C543332', 'term': 'obinutuzumab'}]}}, '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': 'All cause mortality: Up to 56 months SAEs and non-serious AEs: Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy, whichever occurred first (approximately 48 months)', 'description': 'Safety population included all participants who were enrolled in the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days).", 'otherNumAtRisk': 299, 'deathsNumAtRisk': 299, 'otherNumAffected': 113, 'seriousNumAtRisk': 299, 'deathsNumAffected': 54, 'seriousNumAffected': 121}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 221, 'numAffected': 113}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Hyperparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Large intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Malabsorption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Cholangiocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Coronavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 55, 'numAffected': 51}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 31, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Cytomegalovirus infection reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Post-acute COVID-19 syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Psoas abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Cervical vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Endometrial adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Monoplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Alveolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Lung consolidation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Pleural thickening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Renal stone removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Ureteric calculus removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Uterine polypectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.2'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Progression of Disease at Year 2 (POD24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '12.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 2', 'description': "POD24=time from date of treatment initiation with obinutuzumab until first documented PD/death due to PD, whichever occurs first, within 24 months from start of treatment with obinutuzumab. According to standard Cheson criteria \\& Deauville 5-point scale, PD=20% increase in sum of longest diameters (LD) of target lesions; for small lymph nodes measuring \\<15 millimeters (mm) post therapy, a minimum absolute increase of 5 mm \\& LD should exceed 15 mm; appearance of a new lesion; any bone marrow involvement \\& any 18F-fluorodeoxyglucose-positron emission tomography (FDG-PET) results. Participants with no PD \\& who didn't die due to PD/were lost to follow-up at time of analysis were censored at date of last tumor assessment where no progression was documented/last date of follow-up for disease, whichever was last. Participants without post-baseline tumor assessments were censored at time of their baseline visit unless death due to PD occurred prior to their first scheduled tumor assessment.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants with data available for POD24 analysis. Percentages have been rounded off.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Progression-free Survival at Year 2 (PFS2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '85.6', 'groupId': 'OG000', 'lowerLimit': '81.1', 'upperLimit': '89.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 2', 'description': 'PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \\< 15 mm post-therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; the appearance of a new lesion; any bone marrow involvement and any FDG-PET results. Kaplan-Meier estimate of the PFS2 rate at 2 years (that is, the estimated percentage of participants with PFS2 at Year 2) is presented.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Percentages have been rounded off.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PFS at Year 3 (PFS3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '76.6', 'groupId': 'OG000', 'lowerLimit': '71.4', 'upperLimit': '81.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 3', 'description': 'PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \\< 15 mm post therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; appearance of a new lesion; any bone marrow involvement \\& any FDG-PET results. Kaplan-Meier estimate of the PFS3 rate at 3 years (that is, the estimated percentage of participants with PFS3 at Year 3) is presented.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Percentages have been rounded off.'}, {'type': 'SECONDARY', 'title': 'Time to Next Treatment (TTNT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '1118', 'groupId': 'OG000', 'lowerLimit': '167', 'upperLimit': '1478'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 56 months', 'description': 'TTNT was defined as the time to initiation of subsequent systemic anti-cancer therapy following initiation of obinutuzumab containing therapy. Participants who did not start subsequent systemic anti-cancer therapy were censored at the date of the last study visit.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '1269', 'groupId': 'OG000', 'lowerLimit': '1135', 'upperLimit': '1277'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 56 months', 'description': 'OS was defined as the time from initiation of study treatment to death from any cause. Participants who were still alive at the time of analysis and participants who were lost to follow-up were censored at their last time known to be alive.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab.'}, {'type': 'SECONDARY', 'title': 'Time From First Dose to Loss of Clinical Benefit (TTLCB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '1127', 'groupId': 'OG000', 'lowerLimit': '167', 'upperLimit': '1266'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 56 months', 'description': 'TTLCB was defined as the time from first dose to loss of clinical benefit as assessed by the treating physician (single or multiple reasons possible: e.g. PD, deterioration in Eastern Cooperative Oncology Group Performance Status (ECOG PS), death, other). Participants who did not lose clinical benefit were censored at the date of the last study visit. Participants without post-baseline tumor assessments were censored at the time of their baseline visit unless death occurred prior to their first scheduled tumor assessment.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'title': 'During Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '91.2', 'upperLimit': '97.5'}]}]}, {'title': 'End of Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.6', 'groupId': 'OG000', 'lowerLimit': '92.4', 'upperLimit': '97.7'}]}]}, {'title': 'During Maintenance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.6', 'groupId': 'OG000', 'lowerLimit': '89.6', 'upperLimit': '96.5'}]}]}, {'title': 'End of Maintenance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000', 'lowerLimit': '89.5', 'upperLimit': '97.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 56 months', 'description': 'ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) at mid and end of induction (6 months), and during and after maintenance therapy (24 months), as per clinical practice, with and without FDG-PET. Per standard Cheson criteria and Deauville 5-point scale, CR was defined as complete disappearance of all target lesions \\& all nodes with long axis \\< 10 mm or ≥ 30% decrease in sum of LD of target lesions with normalization of FDG-PET (Deauville score 1-3); no new lesions \\& no bone marrow involvement. PR was defined as ≥ 30% decrease in sum of LD of target lesions but not a CR; positive FDG-PET (Deauville score 4-5); no new lesions and any bone marrow involvement. The Deauville 5-Point Scale is based on visual interpretation of FDG uptake. Scale ranges from 1 to 5, where 1 (best)=no FDG uptake; 2=FDG uptake ≤ mediastinum; 3=FDG uptake \\> mediastinum but ≤ liver; 4=FDG uptake moderately \\> liver; 5 (worst)=FDG uptake markedly \\> than liver.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Number analyzed per timepoint are unique number of participants out of all the assessed participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint. Percentages have been rounded off.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'title': 'During Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.9', 'groupId': 'OG000', 'lowerLimit': '29.6', 'upperLimit': '42.6'}]}]}, {'title': 'End of Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.7', 'groupId': 'OG000', 'lowerLimit': '74.4', 'upperLimit': '84.3'}]}]}, {'title': 'During Maintenance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.7', 'groupId': 'OG000', 'lowerLimit': '82.6', 'upperLimit': '91.8'}]}]}, {'title': 'End of Maintenance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.6', 'groupId': 'OG000', 'lowerLimit': '84.9', 'upperLimit': '94.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 56 months', 'description': 'According to standard Cheson criteria and Deauville 5-point scale, CR was defined as complete disappearance of all target lesions and all nodes with long axis \\< 10 mm or ≥ 30% decrease in the sum of LD of target lesions with normalization of FDG-PET (Deauville score 1-3); no new lesions and no bone marrow involvement. CR was assessed at mid and end of induction (6 months), and during and after maintenance therapy (24 months), as per clinical practice, with and without FDG-PET results. The Deauville 5-Point Scale is based on visual interpretation of FDG uptake. Scale ranges from 1 to 5, where 1 (best)=no FDG uptake; 2=FDG uptake ≤ mediastinum; 3=FDG uptake \\> mediastinum but ≤ liver; 4=FDG uptake moderately \\> liver; 5 (worst)=FDG uptake markedly \\> than liver.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Number analyzed per timepoint are unique number of participants out of all the assessed participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint. Percentages have been rounded off.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With CR at 30 Months (CR30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000', 'lowerLimit': '87.1', 'upperLimit': '94'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 30 months', 'description': 'According to standard Cheson criteria and Deauville 5-point scale, CR at 30 months was defined as complete disappearance of all target lesions and all nodes with long axis \\< 10 mm or ≥ 30% decrease in the sum of LD of target lesions with normalization of FDG-PET (Deauville score 1-3); no new lesions and no bone marrow involvement. The Deauville 5-Point Scale is based on visual interpretation of FDG uptake. Scale ranges from 1 to 5, where 1 (best)=no FDG uptake; 2=FDG uptake ≤ mediastinum; 3=FDG uptake \\> mediastinum but ≤ liver; 4=FDG uptake moderately \\> liver; 5 (worst)=FDG uptake markedly \\> than liver.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Percentages have been rounded off.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '1010', 'groupId': 'OG000', 'lowerLimit': '73', 'upperLimit': '1168'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 56 months', 'description': 'DOR=time from first documentation of CR/PR until PD, as evaluated by physician according to routine clinical practice/death. CR=complete disappearance of all target lesions \\& all nodes with long axis \\<10 mm/ ≥30% decrease in sum of LD of target lesions with normalization of FDG-PET (Deauville score 1-3); no new lesions \\& no bone marrow involvement. PR= ≥30% decrease in sum of LD of target lesions but not CR; positive FDG-PET (Deauville score 4-5); no new lesions \\& any bone marrow involvement. PD=20% increase in sum of LD of target lesions; for small lymph nodes measuring \\<15 mm post therapy, minimum absolute increase of 5 mm \\& LD should exceed 15 mm; appearance of new lesion; any bone marrow involvement \\& FDG-PET results. Deauville 5-Point Scale is based on visual interpretation of FDG uptake. Scale ranges from 1-5, where 1 (best)=no FDG uptake; 2=FDG uptake ≤mediastinum; 3=FDG uptake \\>mediastinum but ≤liver; 4=FDG uptake moderately \\>liver; 5 (worst)=FDG uptake markedly \\>than liver.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed included participants with OR i.e responders. Different participants with responses at different timepoints during the study may have contributed to the summarized data.'}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '577'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 56 months', 'description': 'TTR was defined as time from first dose of obinutuzumab to first documented response (CR or PR) as assessed in clinical routine. Per standard Cheson criteria \\& Deauville 5-point scale, CR was defined as the complete disappearance of all target lesions and all nodes with long axis \\< 10 mm or ≥ 30% decrease in the sum of LD of target lesions with normalization of FDG-PET (Deauville score 1-3); no new lesions and no bone marrow involvement. PR was defined as ≥30% decrease in the sum of LD of target lesions but not a CR (Deauville score 4-5); no new lesions \\& any bone marrow involvement. The Deauville 5-Point Scale is based on visual interpretation of FDG uptake. Scale ranges from 1 to 5, where 1 (best)=no FDG uptake; 2=FDG uptake ≤ mediastinum; 3=FDG uptake \\> mediastinum but ≤ liver; 4=FDG uptake moderately \\> liver; 5 (worst)=FDG uptake markedly \\> than liver.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'title': 'During Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '5.2'}]}]}, {'title': 'End of Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '3.7'}]}]}, {'title': 'During Maintenance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '5.2'}]}]}, {'title': 'End of Maintenance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '5.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 56 months', 'description': 'According to standard Cheson criteria and Deauville 5-point scale, SD was defined as \\< 10% decrease or ≤ 20% increase in the sum of LD of target lesions; no new lesions; any bone marrow involvement and any FDG-PET results. SD was assessed at mid and end of induction (6 months), and during and after maintenance therapy (24 months).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Number analyzed per timepoint are unique number of participants out of all the assessed participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint. Percentages have been rounded off.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With FDG-PET Response at End of Induction and End of Maintenance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'title': 'End of Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.6', 'groupId': 'OG000', 'lowerLimit': '92.4', 'upperLimit': '97.7'}]}]}, {'title': 'End of Maintenance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000', 'lowerLimit': '89.5', 'upperLimit': '97.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 56 months', 'description': 'ORR was defined as percentage of participants with a CR/PR at end of induction \\& maintenance therapy, as per clinical practice, with FDG-PET. According to standard Cheson criteria \\& Deauville 5-point scale, CR was defined as complete disappearance of all target lesions \\& all nodes with long axis \\< 10 mm or ≥ 30% decrease in sum of LD of target lesions with normalization of FDG-PET (Deauville score 1-3); no new lesions \\& no bone marrow involvement. PR was defined as ≥30% decrease in sum of LD of target lesions but not a CR; positive FDG-PET (Deauville score 4-5); no new lesions \\& any bone marrow involvement. The Deauville 5-Point Scale is based on visual interpretation of FDG uptake. Scale ranges from 1 to 5, where 1 (best)=no FDG uptake; 2=FDG uptake ≤ mediastinum; 3=FDG uptake \\> mediastinum but ≤ liver; 4=FDG uptake moderately \\> liver; 5 (worst)=FDG uptake markedly \\> than liver.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '287', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy (approximately 48 months)', 'description': 'An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were enrolled in the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy (approximately 48 months)', 'description': "An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any AE that meets any of the following criteria: is fatal; life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study medicine and is a significant medical event in the physician's judgment.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were enrolled in the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events of Special Interests (AESIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy (approximately 48 months)', 'description': "An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AESIs for this study may include the following: tumor lysis syndrome (TLS), irrespective of causality; second malignancies; cases of potential medicine-induced liver injury that include an elevated alanine aminotransferase (ALT) or aspartate transaminase (AST) in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's law and suspected transmission of an infectious agent by the study medicine.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were enrolled in the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Infusion-related Reactions (IRRs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy (approximately 48 months)', 'description': 'An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. IRRs were defined as all AEs that occurred during or within 24 hours after study treatment infusion and were judged to be related to infusion of study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were enrolled in the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PFS2 Stratified by Follicular Lymphoma International Prognostic Index (FLIPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'title': 'FLIPI Score 0', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'FLIPI Score 1', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}]}]}, {'title': 'FLIPI Score 2', 'categories': [{'measurements': [{'value': '37.4', 'groupId': 'OG000'}]}]}, {'title': 'FLIPI Score 3', 'categories': [{'measurements': [{'value': '40.6', 'groupId': 'OG000'}]}]}, {'title': 'FLIPI Score 4', 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000'}]}]}, {'title': 'FLIPI Score 5', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 2', 'description': 'PFS=time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. Per standard Cheson criteria \\& Deauville 5-point scale, PD=20% increase in sum of LD of target lesions; for small lymph nodes measuring \\<15 mm post-therapy, a minimum absolute increase of 5 mm \\& the LD should exceed 15 mm; appearance of a new lesion; any bone marrow involvement \\& any FDG-PET results. The FLIPI tool predicts the prognosis of participants diagnosed with FL. Prognosis depends on 5 FLIPI risk factors: age \\>60 years, Ann Arbor stage III-IV, hemoglobin (Hb) level \\<12 grams per deciliter (gm/dL), \\>4 nodal areas \\& raised lactate dehydrogenase (LDH) levels. Each factor was given a point if it was positive. FLIPI score range from 0-5 where 0-1 = low risk; 2=intermediate risk and 3-5=high risk. Higher score indicates worse prognosis. Participants who were event-free at 2 years, stratified by FLIPI score are presented.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 2 years and were evaluable for this outcome measure. Percentages have been rounded off.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PFS2 Stratified by ECOG PS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'title': 'ECOG PS Score 0', 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000'}]}]}, {'title': 'ECOG PS Score 1', 'categories': [{'measurements': [{'value': '40.8', 'groupId': 'OG000'}]}]}, {'title': 'ECOG PS Score 2', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'ECOG PS Score 3', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'ECOG PS Score 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ECOG PS Score 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 2', 'description': "PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. PD was defined as outlined in the description of outcome measure 1 (POD24). ECOG-PS assessed participant's performance status on a 5 point scale where 0=fully active, able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, but ambulatory, able to carry out light/sedentary work; 2=ambulatory, capable of all self-care, but unable to carry out any work activities (\\>50% of waking hours); 3=capable of only limited self-care, confined to bed/chair (\\>50% of waking hours); 4=completely disabled, cannot carry on any selfcare, totally confined to bed or chair and 5=Dead. Higher score=lower performance. Data for participants who were event-free at 2 years, stratified by ECOG-PS score are presented.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 2 years and were evaluable for this outcome measure. Percentages have been rounded off.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PFS2 Stratified by Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'title': '≤ 60 Years', 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000'}]}]}, {'title': '> 60 Years', 'categories': [{'measurements': [{'value': '55.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 2', 'description': 'PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \\< 15 mm post-therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; the appearance of a new lesion; any bone marrow involvement and any FDG-PET results. Data for participants who were event-free at 2 years, stratified by age (≤60 years \\& \\>60 years) are presented.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 2 years and were evaluable for this outcome measure. Percentages have been rounded off.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PFS2 Stratified by Chemotherapy Backbone Choice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'title': 'Bendamustine', 'categories': [{'measurements': [{'value': '47.3', 'groupId': 'OG000'}]}]}, {'title': 'CHOP', 'categories': [{'measurements': [{'value': '47.3', 'groupId': 'OG000'}]}]}, {'title': 'CVP', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 2', 'description': 'PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \\< 15 mm post-therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; the appearance of a new lesion; any bone marrow involvement and any FDG-PET results. Participants treated with chemotherapy were given the following options: Bendamustine; CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), and CVP (cyclophosphamide, vincristine, prednisone). Data for participants who were event-free at 2 years, stratified by chemotherapy backbone are presented.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 2 years and were evaluable for this outcome measure. Percentages have been rounded off.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PFS2 Stratified by Hepatitis B Virus (HBV) Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'title': 'Positive HBV', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}]}]}, {'title': 'Negative HBV', 'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 2', 'description': 'PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \\< 15 mm post-therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; the appearance of a new lesion; any bone marrow involvement and any FDG-PET results. History of past/resolved infection or latent HBV after prophylaxis as per standard treatment guidelines was assessed. Data for participants who were event-free at 2 years, stratified by positive \\& negative HBV infection are presented.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 2 years and were evaluable for this outcome measure. Percentages have been rounded off.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PFS2 Stratified by Presence of Autoimmune Disease, Renal and Hepatobilliary Disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'title': 'Immune System Disorders', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Hepatobilliary Disorders', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}]}]}, {'title': 'Renal Disorders', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 2', 'description': 'PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \\< 15 mm post-therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; the appearance of a new lesion; any bone marrow involvement and any FDG-PET results. Data for participants who were event-free at 2 years, stratified by a history of autoimmune, renal and hepatobilliary disorders are presented.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 2 years and were evaluable for this outcome measure. Percentages have been rounded off.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PFS3 Stratified by FLIPI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'title': 'FLIPI Score 0', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'FLIPI Score 1', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'FLIPI Score 2', 'categories': [{'measurements': [{'value': '39.6', 'groupId': 'OG000'}]}]}, {'title': 'FLIPI Score 3', 'categories': [{'measurements': [{'value': '40.5', 'groupId': 'OG000'}]}]}, {'title': 'FLIPI Score 4', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}]}]}, {'title': 'FLIPI Score 5', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 3', 'description': 'PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. Per standard Cheson criteria \\& Deauville 5-point scale, PD was defined as 20% increase in sum of LD of target lesions; for small lymph nodes measuring \\<15 mm post-therapy, a minimum absolute increase of 5 mm \\& the LD should exceed 15 mm; appearance of a new lesion; any bone marrow involvement \\& any FDG-PET results. The FLIPI tool predicts the prognosis of participants diagnosed with FL. Prognosis depends on 5 FLIPI risk factors: age \\>60 years, Ann Arbor stage III-IV, Hb level \\<12 gm/dL, \\>4 nodal areas \\& raised LDH levels. Each factor was given a point if it was positive. FLIPI score range from 0-5 where 0-1 = low risk; 2=intermediate risk and 3-5=high risk. Higher score indicates worse prognosis. Participants who were event-free at 3 years, stratified by FLIPI score are presented.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 3 years and were evaluable for this outcome measure. Percentages have been rounded off.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PFS3 Stratified by ECOG PS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'title': 'ECOG PS Score 0', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}]}]}, {'title': 'ECOG PS Score 1', 'categories': [{'measurements': [{'value': '39.7', 'groupId': 'OG000'}]}]}, {'title': 'ECOG PS Score 2', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}]}]}, {'title': 'ECOG PS Score 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ECOG PS Score 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ECOG PS Score 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 3', 'description': "PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. PD was defined as outlined in the description of outcome measure 1 (POD24). ECOG-PS assessed participant's performance status on a 5 point scale where 0=fully active, able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, but ambulatory, able to carry out light/sedentary work; 2=ambulatory, capable of all self-care, but unable to carry out any work activities (\\>50% of waking hours); 3=capable of only limited self-care, confined to bed/chair (\\>50% of waking hours); 4=completely disabled, cannot carry on any selfcare, totally confined to bed or chair and 5=Dead. Higher score=lower performance. Data for participants who were event-free at 3 years, stratified by ECOG-PS score are presented.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 3 years and were evaluable for this outcome measure. Percentages have been rounded off.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PFS3 Stratified by Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'title': '≤ 60 Years', 'categories': [{'measurements': [{'value': '46.3', 'groupId': 'OG000'}]}]}, {'title': '> 60 Years', 'categories': [{'measurements': [{'value': '53.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 3', 'description': 'PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \\< 15 mm post-therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; the appearance of a new lesion; any bone marrow involvement and any FDG-PET results. Data for participants who were event-free at 3 years, stratified by age (≤60 years \\& \\>60 years) are presented.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 3 years and were evaluable for this outcome measure. Percentages have been rounded off.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PFS3 Stratified by Chemotherapy Backbone Choice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'title': 'Bendamustine', 'categories': [{'measurements': [{'value': '45.4', 'groupId': 'OG000'}]}]}, {'title': 'CHOP', 'categories': [{'measurements': [{'value': '48.9', 'groupId': 'OG000'}]}]}, {'title': 'CVP', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 3', 'description': 'PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \\< 15 mm post-therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; the appearance of a new lesion; any bone marrow involvement and any FDG-PET results. Participants treated with chemotherapy were given the following options: Bendamustine; CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), and CVP (cyclophosphamide, vincristine, prednisone). Data for participants who were event-free at 3 years, stratified by chemotherapy backbone are presented.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 3 years and were evaluable for this outcome measure. Percentages have been rounded off.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PFS3 Stratified by HBV Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'title': 'Positive HBV', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}]}]}, {'title': 'Negative HBV', 'categories': [{'measurements': [{'value': '95.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 3', 'description': 'PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \\< 15 mm post-therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; the appearance of a new lesion; any bone marrow involvement and any FDG-PET results. History of past/resolved infection or latent HBV after prophylaxis as per standard treatment guidelines was assessed. Data for participants who were event-free at 3 years, stratified by positive \\& negative HBV infection are presented.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 3 years and were evaluable for this outcome measure. Percentages have been rounded off.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PFS3 Stratified by Presence of Autoimmune Disease, Renal and Hepatobilliary Disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occured first (1 cycle = 28 days)."}], 'classes': [{'title': 'Immune System Disorders', 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}]}]}, {'title': 'Hepatobilliary Disorders', 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000'}]}]}, {'title': 'Renal Disorders', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 3', 'description': 'PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \\< 15 mm post-therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; the appearance of a new lesion; any bone marrow involvement and any FDG-PET results. Data for participants who were event-free at 3 years, stratified by a history of autoimmune, renal and hepatobilliary disorders are presented. Percentages have been rounded off.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were enrolled and received at least two cycles of obinutuzumab. Overall number analyzed is the number of participants who were progression-free at 3 years and were evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days)."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '299'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '228'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '56'}]}]}], 'recruitmentDetails': 'A total of 299 participants with untreated advanced follicular lymphoma (FL) took part in the study at 50 investigative sites in Italy from 02 September 2019 to 22 April 2024.', 'preAssignmentDetails': 'This was a prospective and retrospective data collection study. Participants were observed for safety and efficacy of obinutuzumab during the 6-month induction treatment with obinutuzumab and chemotherapy, and 24-month maintenance treatment with obinutuzumab monotherapy followed by 1 year of follow up.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Obinutuzumab', 'description': "Participants who received at least 2 cycles of obinutuzumab and chemotherapy as IV infusion as induction treatment, followed by obinutuzumab monotherapy as maintenance treatment per physician's decision in accordance with local clinical practice and local labelling were observed for efficacy and safety for up to 3.5 years or until PD, withdrawal of consent, study termination by sponsor or death, whichever occurred first (1 cycle = 28 days)."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '60.8', 'spread': '10.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '158', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '141', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Safety population included all participants who were enrolled in the study.\n\nData for Race and Ethnicity was not collected.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-23', 'size': 2067387, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-04-16T15:13', 'hasProtocol': True}, {'date': '2022-02-01', 'size': 750629, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-04-16T15:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 299}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2019-07-23', 'resultsFirstSubmitDate': '2025-04-16', 'studyFirstSubmitQcDate': '2019-07-24', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-08', 'studyFirstPostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Progression of Disease at Year 2 (POD24)', 'timeFrame': 'At Year 2', 'description': "POD24=time from date of treatment initiation with obinutuzumab until first documented PD/death due to PD, whichever occurs first, within 24 months from start of treatment with obinutuzumab. According to standard Cheson criteria \\& Deauville 5-point scale, PD=20% increase in sum of longest diameters (LD) of target lesions; for small lymph nodes measuring \\<15 millimeters (mm) post therapy, a minimum absolute increase of 5 mm \\& LD should exceed 15 mm; appearance of a new lesion; any bone marrow involvement \\& any 18F-fluorodeoxyglucose-positron emission tomography (FDG-PET) results. Participants with no PD \\& who didn't die due to PD/were lost to follow-up at time of analysis were censored at date of last tumor assessment where no progression was documented/last date of follow-up for disease, whichever was last. Participants without post-baseline tumor assessments were censored at time of their baseline visit unless death due to PD occurred prior to their first scheduled tumor assessment."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Progression-free Survival at Year 2 (PFS2)', 'timeFrame': 'At Year 2', 'description': 'PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \\< 15 mm post-therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; the appearance of a new lesion; any bone marrow involvement and any FDG-PET results. Kaplan-Meier estimate of the PFS2 rate at 2 years (that is, the estimated percentage of participants with PFS2 at Year 2) is presented.'}, {'measure': 'Percentage of Participants With PFS at Year 3 (PFS3)', 'timeFrame': 'At Year 3', 'description': 'PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \\< 15 mm post therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; appearance of a new lesion; any bone marrow involvement \\& any FDG-PET results. Kaplan-Meier estimate of the PFS3 rate at 3 years (that is, the estimated percentage of participants with PFS3 at Year 3) is presented.'}, {'measure': 'Time to Next Treatment (TTNT)', 'timeFrame': 'Up to approximately 56 months', 'description': 'TTNT was defined as the time to initiation of subsequent systemic anti-cancer therapy following initiation of obinutuzumab containing therapy. Participants who did not start subsequent systemic anti-cancer therapy were censored at the date of the last study visit.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 56 months', 'description': 'OS was defined as the time from initiation of study treatment to death from any cause. Participants who were still alive at the time of analysis and participants who were lost to follow-up were censored at their last time known to be alive.'}, {'measure': 'Time From First Dose to Loss of Clinical Benefit (TTLCB)', 'timeFrame': 'Up to approximately 56 months', 'description': 'TTLCB was defined as the time from first dose to loss of clinical benefit as assessed by the treating physician (single or multiple reasons possible: e.g. PD, deterioration in Eastern Cooperative Oncology Group Performance Status (ECOG PS), death, other). Participants who did not lose clinical benefit were censored at the date of the last study visit. Participants without post-baseline tumor assessments were censored at the time of their baseline visit unless death occurred prior to their first scheduled tumor assessment.'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Up to approximately 56 months', 'description': 'ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) at mid and end of induction (6 months), and during and after maintenance therapy (24 months), as per clinical practice, with and without FDG-PET. Per standard Cheson criteria and Deauville 5-point scale, CR was defined as complete disappearance of all target lesions \\& all nodes with long axis \\< 10 mm or ≥ 30% decrease in sum of LD of target lesions with normalization of FDG-PET (Deauville score 1-3); no new lesions \\& no bone marrow involvement. PR was defined as ≥ 30% decrease in sum of LD of target lesions but not a CR; positive FDG-PET (Deauville score 4-5); no new lesions and any bone marrow involvement. The Deauville 5-Point Scale is based on visual interpretation of FDG uptake. Scale ranges from 1 to 5, where 1 (best)=no FDG uptake; 2=FDG uptake ≤ mediastinum; 3=FDG uptake \\> mediastinum but ≤ liver; 4=FDG uptake moderately \\> liver; 5 (worst)=FDG uptake markedly \\> than liver.'}, {'measure': 'Percentage of Participants With CR', 'timeFrame': 'Up to approximately 56 months', 'description': 'According to standard Cheson criteria and Deauville 5-point scale, CR was defined as complete disappearance of all target lesions and all nodes with long axis \\< 10 mm or ≥ 30% decrease in the sum of LD of target lesions with normalization of FDG-PET (Deauville score 1-3); no new lesions and no bone marrow involvement. CR was assessed at mid and end of induction (6 months), and during and after maintenance therapy (24 months), as per clinical practice, with and without FDG-PET results. The Deauville 5-Point Scale is based on visual interpretation of FDG uptake. Scale ranges from 1 to 5, where 1 (best)=no FDG uptake; 2=FDG uptake ≤ mediastinum; 3=FDG uptake \\> mediastinum but ≤ liver; 4=FDG uptake moderately \\> liver; 5 (worst)=FDG uptake markedly \\> than liver.'}, {'measure': 'Percentage of Participants With CR at 30 Months (CR30)', 'timeFrame': 'At 30 months', 'description': 'According to standard Cheson criteria and Deauville 5-point scale, CR at 30 months was defined as complete disappearance of all target lesions and all nodes with long axis \\< 10 mm or ≥ 30% decrease in the sum of LD of target lesions with normalization of FDG-PET (Deauville score 1-3); no new lesions and no bone marrow involvement. The Deauville 5-Point Scale is based on visual interpretation of FDG uptake. Scale ranges from 1 to 5, where 1 (best)=no FDG uptake; 2=FDG uptake ≤ mediastinum; 3=FDG uptake \\> mediastinum but ≤ liver; 4=FDG uptake moderately \\> liver; 5 (worst)=FDG uptake markedly \\> than liver.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 56 months', 'description': 'DOR=time from first documentation of CR/PR until PD, as evaluated by physician according to routine clinical practice/death. CR=complete disappearance of all target lesions \\& all nodes with long axis \\<10 mm/ ≥30% decrease in sum of LD of target lesions with normalization of FDG-PET (Deauville score 1-3); no new lesions \\& no bone marrow involvement. PR= ≥30% decrease in sum of LD of target lesions but not CR; positive FDG-PET (Deauville score 4-5); no new lesions \\& any bone marrow involvement. PD=20% increase in sum of LD of target lesions; for small lymph nodes measuring \\<15 mm post therapy, minimum absolute increase of 5 mm \\& LD should exceed 15 mm; appearance of new lesion; any bone marrow involvement \\& FDG-PET results. Deauville 5-Point Scale is based on visual interpretation of FDG uptake. Scale ranges from 1-5, where 1 (best)=no FDG uptake; 2=FDG uptake ≤mediastinum; 3=FDG uptake \\>mediastinum but ≤liver; 4=FDG uptake moderately \\>liver; 5 (worst)=FDG uptake markedly \\>than liver.'}, {'measure': 'Time to Response (TTR)', 'timeFrame': 'Up to approximately 56 months', 'description': 'TTR was defined as time from first dose of obinutuzumab to first documented response (CR or PR) as assessed in clinical routine. Per standard Cheson criteria \\& Deauville 5-point scale, CR was defined as the complete disappearance of all target lesions and all nodes with long axis \\< 10 mm or ≥ 30% decrease in the sum of LD of target lesions with normalization of FDG-PET (Deauville score 1-3); no new lesions and no bone marrow involvement. PR was defined as ≥30% decrease in the sum of LD of target lesions but not a CR (Deauville score 4-5); no new lesions \\& any bone marrow involvement. The Deauville 5-Point Scale is based on visual interpretation of FDG uptake. Scale ranges from 1 to 5, where 1 (best)=no FDG uptake; 2=FDG uptake ≤ mediastinum; 3=FDG uptake \\> mediastinum but ≤ liver; 4=FDG uptake moderately \\> liver; 5 (worst)=FDG uptake markedly \\> than liver.'}, {'measure': 'Percentage of Participants With SD', 'timeFrame': 'Up to approximately 56 months', 'description': 'According to standard Cheson criteria and Deauville 5-point scale, SD was defined as \\< 10% decrease or ≤ 20% increase in the sum of LD of target lesions; no new lesions; any bone marrow involvement and any FDG-PET results. SD was assessed at mid and end of induction (6 months), and during and after maintenance therapy (24 months).'}, {'measure': 'Percentage of Participants With FDG-PET Response at End of Induction and End of Maintenance', 'timeFrame': 'Up to approximately 56 months', 'description': 'ORR was defined as percentage of participants with a CR/PR at end of induction \\& maintenance therapy, as per clinical practice, with FDG-PET. According to standard Cheson criteria \\& Deauville 5-point scale, CR was defined as complete disappearance of all target lesions \\& all nodes with long axis \\< 10 mm or ≥ 30% decrease in sum of LD of target lesions with normalization of FDG-PET (Deauville score 1-3); no new lesions \\& no bone marrow involvement. PR was defined as ≥30% decrease in sum of LD of target lesions but not a CR; positive FDG-PET (Deauville score 4-5); no new lesions \\& any bone marrow involvement. The Deauville 5-Point Scale is based on visual interpretation of FDG uptake. Scale ranges from 1 to 5, where 1 (best)=no FDG uptake; 2=FDG uptake ≤ mediastinum; 3=FDG uptake \\> mediastinum but ≤ liver; 4=FDG uptake moderately \\> liver; 5 (worst)=FDG uptake markedly \\> than liver.'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy (approximately 48 months)', 'description': 'An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy (approximately 48 months)', 'description': "An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any AE that meets any of the following criteria: is fatal; life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study medicine and is a significant medical event in the physician's judgment."}, {'measure': 'Number of Participants With Adverse Events of Special Interests (AESIs)', 'timeFrame': 'Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy (approximately 48 months)', 'description': "An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AESIs for this study may include the following: tumor lysis syndrome (TLS), irrespective of causality; second malignancies; cases of potential medicine-induced liver injury that include an elevated alanine aminotransferase (ALT) or aspartate transaminase (AST) in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's law and suspected transmission of an infectious agent by the study medicine."}, {'measure': 'Number of Participants With Infusion-related Reactions (IRRs)', 'timeFrame': 'Up to 185 days after the final obinutuzumab dose or until initiation of another anti-cancer therapy (approximately 48 months)', 'description': 'An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. IRRs were defined as all AEs that occurred during or within 24 hours after study treatment infusion and were judged to be related to infusion of study treatment.'}, {'measure': 'Percentage of Participants With PFS2 Stratified by Follicular Lymphoma International Prognostic Index (FLIPI)', 'timeFrame': 'At Year 2', 'description': 'PFS=time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. Per standard Cheson criteria \\& Deauville 5-point scale, PD=20% increase in sum of LD of target lesions; for small lymph nodes measuring \\<15 mm post-therapy, a minimum absolute increase of 5 mm \\& the LD should exceed 15 mm; appearance of a new lesion; any bone marrow involvement \\& any FDG-PET results. The FLIPI tool predicts the prognosis of participants diagnosed with FL. Prognosis depends on 5 FLIPI risk factors: age \\>60 years, Ann Arbor stage III-IV, hemoglobin (Hb) level \\<12 grams per deciliter (gm/dL), \\>4 nodal areas \\& raised lactate dehydrogenase (LDH) levels. Each factor was given a point if it was positive. FLIPI score range from 0-5 where 0-1 = low risk; 2=intermediate risk and 3-5=high risk. Higher score indicates worse prognosis. Participants who were event-free at 2 years, stratified by FLIPI score are presented.'}, {'measure': 'Percentage of Participants With PFS2 Stratified by ECOG PS', 'timeFrame': 'At Year 2', 'description': "PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. PD was defined as outlined in the description of outcome measure 1 (POD24). ECOG-PS assessed participant's performance status on a 5 point scale where 0=fully active, able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, but ambulatory, able to carry out light/sedentary work; 2=ambulatory, capable of all self-care, but unable to carry out any work activities (\\>50% of waking hours); 3=capable of only limited self-care, confined to bed/chair (\\>50% of waking hours); 4=completely disabled, cannot carry on any selfcare, totally confined to bed or chair and 5=Dead. Higher score=lower performance. Data for participants who were event-free at 2 years, stratified by ECOG-PS score are presented."}, {'measure': 'Percentage of Participants With PFS2 Stratified by Age', 'timeFrame': 'At Year 2', 'description': 'PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \\< 15 mm post-therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; the appearance of a new lesion; any bone marrow involvement and any FDG-PET results. Data for participants who were event-free at 2 years, stratified by age (≤60 years \\& \\>60 years) are presented.'}, {'measure': 'Percentage of Participants With PFS2 Stratified by Chemotherapy Backbone Choice', 'timeFrame': 'At Year 2', 'description': 'PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \\< 15 mm post-therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; the appearance of a new lesion; any bone marrow involvement and any FDG-PET results. Participants treated with chemotherapy were given the following options: Bendamustine; CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), and CVP (cyclophosphamide, vincristine, prednisone). Data for participants who were event-free at 2 years, stratified by chemotherapy backbone are presented.'}, {'measure': 'Percentage of Participants With PFS2 Stratified by Hepatitis B Virus (HBV) Infection', 'timeFrame': 'At Year 2', 'description': 'PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \\< 15 mm post-therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; the appearance of a new lesion; any bone marrow involvement and any FDG-PET results. History of past/resolved infection or latent HBV after prophylaxis as per standard treatment guidelines was assessed. Data for participants who were event-free at 2 years, stratified by positive \\& negative HBV infection are presented.'}, {'measure': 'Percentage of Participants With PFS2 Stratified by Presence of Autoimmune Disease, Renal and Hepatobilliary Disorders', 'timeFrame': 'At Year 2', 'description': 'PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \\< 15 mm post-therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; the appearance of a new lesion; any bone marrow involvement and any FDG-PET results. Data for participants who were event-free at 2 years, stratified by a history of autoimmune, renal and hepatobilliary disorders are presented.'}, {'measure': 'Percentage of Participants With PFS3 Stratified by FLIPI', 'timeFrame': 'At Year 3', 'description': 'PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. Per standard Cheson criteria \\& Deauville 5-point scale, PD was defined as 20% increase in sum of LD of target lesions; for small lymph nodes measuring \\<15 mm post-therapy, a minimum absolute increase of 5 mm \\& the LD should exceed 15 mm; appearance of a new lesion; any bone marrow involvement \\& any FDG-PET results. The FLIPI tool predicts the prognosis of participants diagnosed with FL. Prognosis depends on 5 FLIPI risk factors: age \\>60 years, Ann Arbor stage III-IV, Hb level \\<12 gm/dL, \\>4 nodal areas \\& raised LDH levels. Each factor was given a point if it was positive. FLIPI score range from 0-5 where 0-1 = low risk; 2=intermediate risk and 3-5=high risk. Higher score indicates worse prognosis. Participants who were event-free at 3 years, stratified by FLIPI score are presented.'}, {'measure': 'Percentage of Participants With PFS3 Stratified by ECOG PS', 'timeFrame': 'At Year 3', 'description': "PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. PD was defined as outlined in the description of outcome measure 1 (POD24). ECOG-PS assessed participant's performance status on a 5 point scale where 0=fully active, able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, but ambulatory, able to carry out light/sedentary work; 2=ambulatory, capable of all self-care, but unable to carry out any work activities (\\>50% of waking hours); 3=capable of only limited self-care, confined to bed/chair (\\>50% of waking hours); 4=completely disabled, cannot carry on any selfcare, totally confined to bed or chair and 5=Dead. Higher score=lower performance. Data for participants who were event-free at 3 years, stratified by ECOG-PS score are presented."}, {'measure': 'Percentage of Participants With PFS3 Stratified by Age', 'timeFrame': 'At Year 3', 'description': 'PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \\< 15 mm post-therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; the appearance of a new lesion; any bone marrow involvement and any FDG-PET results. Data for participants who were event-free at 3 years, stratified by age (≤60 years \\& \\>60 years) are presented.'}, {'measure': 'Percentage of Participants With PFS3 Stratified by Chemotherapy Backbone Choice', 'timeFrame': 'At Year 3', 'description': 'PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \\< 15 mm post-therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; the appearance of a new lesion; any bone marrow involvement and any FDG-PET results. Participants treated with chemotherapy were given the following options: Bendamustine; CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), and CVP (cyclophosphamide, vincristine, prednisone). Data for participants who were event-free at 3 years, stratified by chemotherapy backbone are presented.'}, {'measure': 'Percentage of Participants With PFS3 Stratified by HBV Infection', 'timeFrame': 'At Year 3', 'description': 'PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \\< 15 mm post-therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; the appearance of a new lesion; any bone marrow involvement and any FDG-PET results. History of past/resolved infection or latent HBV after prophylaxis as per standard treatment guidelines was assessed. Data for participants who were event-free at 3 years, stratified by positive \\& negative HBV infection are presented.'}, {'measure': 'Percentage of Participants With PFS3 Stratified by Presence of Autoimmune Disease, Renal and Hepatobilliary Disorders', 'timeFrame': 'At Year 3', 'description': 'PFS was defined as the time from the date of treatment initiation until the first documented PD measured by routine clinical care or death from any cause, whichever occurred first. According to standard Cheson criteria and Deauville 5-point scale, PD was defined as 20% increase in the sum of LD of target lesions; for small lymph nodes measuring \\< 15 mm post-therapy, a minimum absolute increase of 5 mm and the LD should exceed 15 mm; the appearance of a new lesion; any bone marrow involvement and any FDG-PET results. Data for participants who were event-free at 3 years, stratified by a history of autoimmune, renal and hepatobilliary disorders are presented. Percentages have been rounded off.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['Follicular Lymphoma']}, 'referencesModule': {'references': [{'pmid': '39039666', 'type': 'DERIVED', 'citation': 'Pinto A, Caltagirone M, Battista M, Gazzoli GC, Patti C, Pennese E, De Lorenzo S, Pavone V, Merli M, Chiarenza A, Gorgone AG, Piazza F, Puccini B, Noto A, Arcaini L, De Filippi R, Zinzani PL, Ferreri AJM, Ladetto M, Ferrari S, Gritti G. Exposure to obinutuzumab does not affect outcomes of SARS-CoV-2 infection in vaccinated patients with newly diagnosed advanced-stage follicular lymphoma. Br J Haematol. 2024 Dec;205(6):2219-2227. doi: 10.1111/bjh.19661. Epub 2024 Jul 22.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effectiveness and safety of obinutuzumab in clinical routine in 1L FL measured by the % of relapse within 24 months from start of therapy.', 'detailedDescription': 'This observational study has been planned to evaluate the effectiveness of obinutuzumab in combination with chemotherapy in previously untreated advanced FL patients, in the real world setting in Italy. The study will allow to collect real-life data in a significant number of Italian patients when compared to participants in pivotal studies of obinutuzumab and thus will allow to verify in routine practice (after physician hands-on) the effectiveness and safety management in 50 reference sites all over the country.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patient population taking part in the study will comprise patients aged ≥ 18 years in first treatment for advanced FL, in which Obinutuzumab are administered in combination with chemotherapy during the induction phase, followed by Obinutuzumab maintenance therapy. This indication and treatment scheme is that approved by the EMA as per EU countries agency and AIFA as per Italian local agency.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed Informed consent according to local regulations, after performing at least 2 cycles of induction treatment with Obinutuzumab and chemotherapy, within 1 year from beginning of treatment\n\nExclusion Criteria:\n\n* Any contraindications to Obinutuzumab therapy according to local label for specific indication;\n* Concomitant participation in an interventional clinical study;\n* Participants not receiving treatment for untreated follicular lymphoma with Obinutuzumab according to standard of care and in line with local labeling.'}, 'identificationModule': {'nctId': 'NCT04034056', 'acronym': 'URBAN', 'briefTitle': 'Untreated FolliculaR Lymphoma Treated With OBinituzumAb in a Non-interventional Study (URBAN)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Non-Interventional, Retrospective And Prospective, Multicenter, Single Arm Study Evaluating The Effectiveness And Safety Of Obinutuzumab In Patients With Previously Untreated Advanced Follicular Lymphoma', 'orgStudyIdInfo': {'id': 'ML41215'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obinutuzumab', 'interventionNames': ['Drug: Obinutuzumab']}], 'interventions': [{'name': 'Obinutuzumab', 'type': 'DRUG', 'description': 'Induction phase: 1000 milligram (mg) intravenously (IV) on Day 1, 8, 15 of Cycle 1 an Day 1 of Cycles 2-6 or 2-8. Maintenance phase: 1000 mg IV every 2 months for 2 years or until disease progression (whatever occurs earlier).', 'armGroupLabels': ['Obinutuzumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65100', 'city': 'Pescara', 'state': 'Abruzzo', 'country': 'Italy', 'facility': 'Ospedale Civile Dello Spirito Santo', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}, {'zip': '70124', 'city': 'Bari', 'state': 'Apulia', 'country': 'Italy', 'facility': 'AOU Policlinico Consorziale', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '70124', 'city': 'Bari', 'state': 'Apulia', 'country': 'Italy', 'facility': 'Giovanni Paolo II/I.R.C.C.S. Istituto Tumori', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '75121', 'city': 'Barletta', 'state': 'Apulia', 'country': 'Italy', 'facility': 'Asl Bat Ospedale Mons. 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Maria', 'geoPoint': {'lat': 42.56335, 'lon': 12.64329}}, {'zip': 'DUMMY_VALUE', 'city': 'Padua', 'state': 'Veneto', 'country': 'Italy', 'facility': 'Ematologia/immunologia Clinica Azienda Ospedaliera Policlinico di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '31100', 'city': 'Treviso', 'state': 'Veneto', 'country': 'Italy', 'facility': 'Ospedale Ca Foncello', 'geoPoint': {'lat': 45.66673, 'lon': 12.2416}}, {'zip': '37134', 'city': 'Verona', 'state': 'Veneto', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\\_and\\_development/who\\_we\\_are\\_how\\_we\\_work/clinical\\_trials/our\\_commitment\\_to\\_data\\_sharing.htm)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}