Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT01414205
Status:
COMPLETED
Last Update Posted:
2017-04-17
First Post:
2011-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study Comparing Obinutuzumab (RO5072759; GA101) 1000 Milligram (mg) Versus 2000 mg in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GAGE)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C543332', 'term': 'obinutuzumab'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffman-LaRoche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 4 years, 5 months', 'eventGroups': [{'id': 'EG000', 'title': 'Obinutuzumab 1000 mg', 'description': 'Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.', 'otherNumAtRisk': 40, 'otherNumAffected': 40, 'seriousNumAtRisk': 40, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Obinutuzumab 2000 mg', 'description': 'Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.', 'otherNumAtRisk': 38, 'otherNumAffected': 38, 'seriousNumAtRisk': 38, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 24}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood magnesium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab 1000 mg', 'description': 'Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}, {'id': 'OG001', 'title': 'Obinutuzumab 2000 mg', 'description': 'Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0779', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (Hauck-Anderson)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.89', 'ciLowerLimit': '-4.95', 'ciUpperLimit': '40.72', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values based on stratified Cochran-Mantel-Haenszel test by the randomization stratification factors as supportive analyses.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 32', 'description': 'ORR was defined as the percentage of participants with complete response (CR), CR with incomplete marrow recovery (CRi) or partial response (PR) as assessed by the investigator according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines two months after last treatment. CR required: blood lymphocytes \\< 4 x 10\\^9/Liter (L), absence of lymphadenopathy (≤ 1.5 centimeter (cm) in long axis by Computed Tomography), no hepatomegaly or splenomegaly, absence of disease, Neutrophils \\> 1.5 x 10\\^9/L, Platelets \\> 100 x 10\\^9/L, Hemoglobin \\>11 g/dL, bone marrow normal and lymphoid nodules absent. CRi was CR with incomplete marrow recovery. PR required: 50% decrease in peripheral blood lymphocyte count, 50% reduction in lymphadenopathy, 50% reduction of liver and/or spleen enlargement if enlarged at baseline, Neutrophils \\> 1.5 x 10\\^9/L or \\> 50% of pretreatment value, Platelets \\> 100 x 10\\^9/L or 50% of pretreatment value and Hemoglobin \\> 11 g/dL or \\> 50% of pretreatment value.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab 1000 mg', 'description': 'Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}, {'id': 'OG001', 'title': 'Obinutuzumab 2000 mg', 'description': 'Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.2', 'groupId': 'OG000', 'lowerLimit': '15.9', 'upperLimit': '30.4'}, {'value': '26.0', 'groupId': 'OG001', 'lowerLimit': '20.2', 'upperLimit': '34.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 4 years, 5 months', 'description': 'PFS was defined as the time from the randomization to the first occurrence of progression or death, whichever occurred first.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'timeFrame': 'Up to 4 years, 5 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Duration of response was not analyzed as investigators did not perform response assessments at regular intervals during the follow-up period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Surviving at End-of-Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab 1000 mg', 'description': 'Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}, {'id': 'OG001', 'title': 'Obinutuzumab 2000 mg', 'description': 'Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 years, 5 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab 1000 mg', 'description': 'Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}, {'id': 'OG001', 'title': 'Obinutuzumab 2000 mg', 'description': 'Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '21.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 years, 5 months', 'description': 'An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. A SAE was any AE that was one of the following: fatal, life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product or considered a significant medical event by the investigator. Additional information about AEs can be found in the Adverse Event Section.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events of Interest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab 1000 mg', 'description': 'Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}, {'id': 'OG001', 'title': 'Obinutuzumab 2000 mg', 'description': 'Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}], 'classes': [{'title': 'Serious Infusion-Related Reactions (IRR)', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}]}]}, {'title': 'Serious Neutropenia', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}]}]}, {'title': 'Serious Infection', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}]}]}, {'title': 'Tumor Lysis Syndrome', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Hepatitis B Reactivation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 years, 5 months', 'description': 'Adverse Events of interest for this study were: serious infusion related reactions during or within 24 hours of infusion, serious neutropenia, serious infection, tumor lysis syndrome and Hepatitis B reactivation.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events Leading to Study Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab 1000 mg', 'description': 'Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}, {'id': 'OG001', 'title': 'Obinutuzumab 2000 mg', 'description': 'Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 years, 5 months', 'description': 'An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'PK Parameter: Maximum Serum Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab 1000 mg', 'description': 'Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}, {'id': 'OG001', 'title': 'Obinutuzumab 2000 mg', 'description': 'Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '600', 'spread': '45.6', 'groupId': 'OG000'}, {'value': '1190', 'spread': '34.9', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 148 (at end of infusion)', 'description': 'Blood was collected for Pharmacokinetic (PK) Parameter Cmax after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL).', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received study drug with PK data available for analysis.'}, {'type': 'SECONDARY', 'title': 'PK Parameter: Area Under the Serum Concentration-Time Curve Between Dosing Interval Tau (AUCt )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab 1000 mg', 'description': 'Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}, {'id': 'OG001', 'title': 'Obinutuzumab 2000 mg', 'description': 'Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '8230', 'spread': '58.3', 'groupId': 'OG000'}, {'value': '16500', 'spread': '50.3', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)', 'description': 'Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in day times micrograms per milliliter (day\\*μg/mL).', 'unitOfMeasure': 'day*μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.'}, {'type': 'SECONDARY', 'title': 'PK Parameter: Clearance at Steady State (CLss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab 1000 mg', 'description': 'Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}, {'id': 'OG001', 'title': 'Obinutuzumab 2000 mg', 'description': 'Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '121', 'spread': '58.3', 'groupId': 'OG000'}, {'value': '122', 'spread': '50.3', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)', 'description': 'Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). CLss is reported in milliliters per day (mL/day).', 'unitOfMeasure': 'mL/day', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.'}, {'type': 'SECONDARY', 'title': 'PK Parameter: Volume of Distribution at Steady State (Vss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab 1000 mg', 'description': 'Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}, {'id': 'OG001', 'title': 'Obinutuzumab 2000 mg', 'description': 'Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.08', 'spread': '73.2', 'groupId': 'OG000'}, {'value': '6.68', 'spread': '74.7', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)', 'description': 'Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Vss is reported in liters.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.'}, {'type': 'SECONDARY', 'title': 'PK Parameter: Terminal Half-Life (t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab 1000 mg', 'description': 'Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}, {'id': 'OG001', 'title': 'Obinutuzumab 2000 mg', 'description': 'Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.6', 'spread': '87.1', 'groupId': 'OG000'}, {'value': '26.3', 'spread': '80.1', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)', 'description': 'Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). T1/2 was reported in Days.', 'unitOfMeasure': 'Days', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.'}, {'type': 'SECONDARY', 'title': 'PK: Serum Concentrations of Obinutuzumab (Follow-Up Visits)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab 1000 mg', 'description': 'Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}, {'id': 'OG001', 'title': 'Obinutuzumab 2000 mg', 'description': 'Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}], 'classes': [{'title': 'Month 3 (n=14, 10)', 'categories': [{'measurements': [{'value': '41.2', 'spread': '63.3', 'groupId': 'OG000'}, {'value': '98.9', 'spread': '88.9', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 (n=19, 15)', 'categories': [{'measurements': [{'value': '15', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '12.6', 'spread': '17.7', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 (n=24, 23)', 'categories': [{'measurements': [{'value': '2.63', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '4.09', 'spread': '9.42', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 (n=16, 18)', 'categories': [{'measurements': [{'value': '0.633', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '0.857', 'spread': '1.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 3, 6, 9, and 12', 'description': 'Blood serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL).', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics: Number of Participants With Peripheral Blood B-cell Depletion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab 1000 mg', 'description': 'Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}, {'id': 'OG001', 'title': 'Obinutuzumab 2000 mg', 'description': 'Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}], 'classes': [{'title': 'At Last Antibody Administration (n=40, 38)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Up to 6 Months of Follow-Up (FU) (n=30, 31)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Within 6-12 Months of Follow-up (n=24, 24)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Within 12-18 Months of Follow-up (n=17, 17)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Within 18-24 Months of Follow-up (n=10, 9)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Within 24-30 Months of Follow-up (n=4, 6)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Within 30-36 Months of Follow-up (n=1, 3)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Within 36-42 Months of Follow-up (n=0, 0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'After 42 Months of Follow-up (n=0, 0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 years, 5 months', 'description': 'Blood was sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry. B-cell depletion was defined as a CD19 result \\< 0.07 × 10\\^9/L after at least one dose of study drug has been administered.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Safety Evaluable Population, all randomized participants who received at least one dose of study drug, who had data available for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics: Number of Participants With Peripheral Blood B-cell Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab 1000 mg', 'description': 'Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}, {'id': 'OG001', 'title': 'Obinutuzumab 2000 mg', 'description': 'Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}], 'classes': [{'title': 'Up to 6 Months FU: Recovery with PD (n=30, 31)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Up to 6 Months FU: Recovery without PD (n=30, 31)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '6-12 Months FU: Recovery with PD (n=24, 24)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '6-12 Months FU: Recovery without PD (n=24, 24)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '12-18 Months FU: Recovery with PD (n=17, 17)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '12-18 Months FU: Recovery without PD (n=17, 17)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': '18-24 Months FU: Recovery with PD (n=10, 9)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '18-24 Months FU: Recovery without PD (n=10, 9)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '24-30 Months FU: Recovery with PD (n=4, 6)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '24-30 Months FU: Recovery without PD (n=4, 6)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '30-36 Months FU: Recovery with PD (n=1, 3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '30-36 Months FU: Recovery without PD (n=1, 3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '36-42 Months FU: Recovery with PD (n=0, 0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '36-42 Months FU: Recovery without PD (n=0, 0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'After 42 Months FU: Recovery with PD (n=0, 0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'After 42 Months FU: Recovery without PD (n=0, 0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 years, 5 months', 'description': 'Blood was sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry. B-cell recovery was defined as a CD19 result ≥ 0.07 × 10\\^9/L, where CD19 was previously depleted. B-cell recovery was only considered possible following the last dose of study treatment. The number of participants with B-cell recovery from End of Treatment to 6 months of Follow-up is reported in two categories: Recovery with Progressive Disease (PD) \\[PD before B-cell recovery or PD within 45 days after recovery\\] or Recovery without PD. PD required one of the following: 50% increase in the absolute number of circulating lymphocytes, Appearance of new palpable lymph nodes, 50% increase in the longest diameter of any previous site of lymphadenopathy, 50% increase in the enlargement of the liver and/or spleen or Transformation to a more aggressive histology.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Safety Evaluable Population, all randomized participants who received at least one dose of study drug, with B-Cell depletion.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Obinutuzumab 1000 mg', 'description': 'Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}, {'id': 'FG001', 'title': 'Obinutuzumab 2000 mg', 'description': 'Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Randomized but not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Obinutuzumab 1000 mg', 'description': 'Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}, {'id': 'BG001', 'title': 'Obinutuzumab 2000 mg', 'description': 'Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.0', 'spread': '10.0', 'groupId': 'BG000'}, {'value': '64.3', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '65.7', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-20', 'studyFirstSubmitDate': '2011-08-10', 'resultsFirstSubmitDate': '2014-03-21', 'studyFirstSubmitQcDate': '2011-08-10', 'lastUpdatePostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-03-21', 'studyFirstPostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Week 32', 'description': 'ORR was defined as the percentage of participants with complete response (CR), CR with incomplete marrow recovery (CRi) or partial response (PR) as assessed by the investigator according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines two months after last treatment. CR required: blood lymphocytes \\< 4 x 10\\^9/Liter (L), absence of lymphadenopathy (≤ 1.5 centimeter (cm) in long axis by Computed Tomography), no hepatomegaly or splenomegaly, absence of disease, Neutrophils \\> 1.5 x 10\\^9/L, Platelets \\> 100 x 10\\^9/L, Hemoglobin \\>11 g/dL, bone marrow normal and lymphoid nodules absent. CRi was CR with incomplete marrow recovery. PR required: 50% decrease in peripheral blood lymphocyte count, 50% reduction in lymphadenopathy, 50% reduction of liver and/or spleen enlargement if enlarged at baseline, Neutrophils \\> 1.5 x 10\\^9/L or \\> 50% of pretreatment value, Platelets \\> 100 x 10\\^9/L or 50% of pretreatment value and Hemoglobin \\> 11 g/dL or \\> 50% of pretreatment value.'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Up to 4 years, 5 months', 'description': 'PFS was defined as the time from the randomization to the first occurrence of progression or death, whichever occurred first.'}, {'measure': 'Duration of Response', 'timeFrame': 'Up to 4 years, 5 months'}, {'measure': 'Number of Participants Surviving at End-of-Study', 'timeFrame': 'Up to 4 years, 5 months'}, {'measure': 'Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)', 'timeFrame': 'Up to 4 years, 5 months', 'description': 'An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. A SAE was any AE that was one of the following: fatal, life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product or considered a significant medical event by the investigator. Additional information about AEs can be found in the Adverse Event Section.'}, {'measure': 'Percentage of Participants With Adverse Events of Interest', 'timeFrame': 'Up to 4 years, 5 months', 'description': 'Adverse Events of interest for this study were: serious infusion related reactions during or within 24 hours of infusion, serious neutropenia, serious infection, tumor lysis syndrome and Hepatitis B reactivation.'}, {'measure': 'Percentage of Participants With Adverse Events Leading to Study Discontinuation', 'timeFrame': 'Up to 4 years, 5 months', 'description': 'An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution.'}, {'measure': 'PK Parameter: Maximum Serum Concentration (Cmax)', 'timeFrame': 'Day 148 (at end of infusion)', 'description': 'Blood was collected for Pharmacokinetic (PK) Parameter Cmax after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL).'}, {'measure': 'PK Parameter: Area Under the Serum Concentration-Time Curve Between Dosing Interval Tau (AUCt )', 'timeFrame': 'Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)', 'description': 'Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in day times micrograms per milliliter (day\\*μg/mL).'}, {'measure': 'PK Parameter: Clearance at Steady State (CLss)', 'timeFrame': 'Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)', 'description': 'Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). CLss is reported in milliliters per day (mL/day).'}, {'measure': 'PK Parameter: Volume of Distribution at Steady State (Vss)', 'timeFrame': 'Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)', 'description': 'Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Vss is reported in liters.'}, {'measure': 'PK Parameter: Terminal Half-Life (t1/2)', 'timeFrame': 'Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)', 'description': 'Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). T1/2 was reported in Days.'}, {'measure': 'PK: Serum Concentrations of Obinutuzumab (Follow-Up Visits)', 'timeFrame': 'Months 3, 6, 9, and 12', 'description': 'Blood serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL).'}, {'measure': 'Pharmacodynamics: Number of Participants With Peripheral Blood B-cell Depletion', 'timeFrame': 'Up to 4 years, 5 months', 'description': 'Blood was sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry. B-cell depletion was defined as a CD19 result \\< 0.07 × 10\\^9/L after at least one dose of study drug has been administered.'}, {'measure': 'Pharmacodynamics: Number of Participants With Peripheral Blood B-cell Recovery', 'timeFrame': 'Up to 4 years, 5 months', 'description': 'Blood was sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry. B-cell recovery was defined as a CD19 result ≥ 0.07 × 10\\^9/L, where CD19 was previously depleted. B-cell recovery was only considered possible following the last dose of study treatment. The number of participants with B-cell recovery from End of Treatment to 6 months of Follow-up is reported in two categories: Recovery with Progressive Disease (PD) \\[PD before B-cell recovery or PD within 45 days after recovery\\] or Recovery without PD. PD required one of the following: 50% increase in the absolute number of circulating lymphocytes, Appearance of new palpable lymph nodes, 50% increase in the longest diameter of any previous site of lymphadenopathy, 50% increase in the enlargement of the liver and/or spleen or Transformation to a more aggressive histology.'}]}, 'conditionsModule': {'conditions': ['Lymphocytic Leukemia, Chronic']}, 'referencesModule': {'references': [{'pmid': '26472752', 'type': 'DERIVED', 'citation': 'Byrd JC, Flynn JM, Kipps TJ, Boxer M, Kolibaba KS, Carlile DJ, Fingerle-Rowson G, Tyson N, Hirata J, Sharman JP. Randomized phase 2 study of obinutuzumab monotherapy in symptomatic, previously untreated chronic lymphocytic leukemia. Blood. 2016 Jan 7;127(1):79-86. doi: 10.1182/blood-2015-03-634394. Epub 2015 Oct 15.'}]}, 'descriptionModule': {'briefSummary': 'This open-label, multicenter, randomized study compared the efficacy, safety and pharmacokinetics of obinutuzumab (RO5072759; GA101) 1000 mg versus 2000 mg in participants with previously untreated CLL. Participants were randomized to receive a maximum of 8 cycles (28-day cycle) of obinutuzumab (1000 mg intravenous \\[IV\\] infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of each subsequent cycle up to 8 cycles or maximum of 8 cycles of obinutuzumab (2000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of each subsequent cycle up to 8 cycles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of CD20-positive B-cell CLL (per International Workshop on Chronic Lymphocytic Leukemia \\[IWCLL\\] guidelines)\n* Rai Stage III/IV or Binet Stage C disease, or Rai Stage I/II or Binet Stage B disease that requires treatment according to IWCLL guidelines\n* No previous treatment for CLL chemotherapy, radiotherapy or immunotherapy; no previous rituximab treatment for autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP); prior use of steroids for AIHA or ITP is allowed\n* Eastern Cooperative Oncology Group performance status of 0, 1 or 2\n\nExclusion Criteria:\n\n* Confirmed diagnosis of Transformation of CLL to aggressive B-cell malignancy\n* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy\n* Evidence of severe, uncontrolled concomitant disease\n* Known active infection or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks before the start of Cycle 1\n* Seropositive for human immunodeficiency virus (HIV)\n* Positive for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \\[HBsAg\\] serology)\n* Positive for hepatitis C (hepatitis C virus \\[HCV\\] antibody serology testing)\n* Pregnant or lactating women\n* Concurrent (or within 7 days prior to first dose of study treatment) systemic corticosteroid use, except for low-dose corticosteroid therapy used to treat chronic medical conditions'}, 'identificationModule': {'nctId': 'NCT01414205', 'briefTitle': 'A Study Comparing Obinutuzumab (RO5072759; GA101) 1000 Milligram (mg) Versus 2000 mg in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GAGE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'An Open-label, Multicenter, Randomized Phase II Trial Comparing the Efficacy, Safety, and Pharmacokinetics of GA101 1000 mg Versus 2000 mg in Patients With Previously Untreated Chronic Lymphocytic Leukemia', 'orgStudyIdInfo': {'id': 'GAO4768g'}, 'secondaryIdInfos': [{'id': 'GO25677', 'type': 'OTHER', 'domain': 'Hoffmann-La Roche'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Obinutuzumab 1000 mg', 'description': 'Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.', 'interventionNames': ['Drug: Obinutuzumab', 'Drug: Corticosteroids']}, {'type': 'EXPERIMENTAL', 'label': 'Obinutuzumab 2000 mg', 'description': 'Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.', 'interventionNames': ['Drug: Obinutuzumab', 'Drug: Corticosteroids']}], 'interventions': [{'name': 'Obinutuzumab', 'type': 'DRUG', 'otherNames': ['RO5072759; GA101'], 'description': 'Participants were administered obinutuzumab either at 1000 mg or 2000 mg on Day 1, 8, 15 of Cycle 1 and then on Day 1 of each 21 day cycles for up to 8 cycles.', 'armGroupLabels': ['Obinutuzumab 1000 mg', 'Obinutuzumab 2000 mg']}, {'name': 'Corticosteroids', 'type': 'DRUG', 'description': 'Participants were administered corticosteroids IV prior to the initial dose.', 'armGroupLabels': ['Obinutuzumab 1000 mg', 'Obinutuzumab 2000 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35291-3300', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Univ of Alabama at Birmingham; UAB Comprehensive Cancer Ctr', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Oncology', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85715', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Clinical Research Ctr', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California; Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC Norris Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Can Ctr; IDS Pharm', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93030', 'city': 'Oxnard', 'state': 'California', 'country': 'United States', 'facility': 'Ventura County Hematology-Oncology Specialists', 'geoPoint': {'lat': 34.1975, 'lon': -119.17705}}, {'zip': '91750', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Wilshire Oncology Medical Group', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Univ of Colorado Canc Ctr', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Center; Medical Oncology', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '83854', 'city': 'Post Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Kootenai Cancer Center', 'geoPoint': {'lat': 47.71796, 'lon': -116.95159}}, {'zip': '46526', 'city': 'Goshen', 'state': 'Indiana', 'country': 'United States', 'facility': 'Goshen Hlth Sys Ctr Can Care', 'geoPoint': {'lat': 41.58227, 'lon': -85.83444}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Melvin and Bren Simon Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '47905', 'city': 'Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Horizon Oncology Research, Inc.', 'geoPoint': {'lat': 40.4167, 'lon': -86.87529}}, {'zip': '42001', 'city': 'Paducah', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Purchase Cancer Group', 'geoPoint': {'lat': 37.08339, 'lon': -88.60005}}, {'zip': '07962', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hem Onc Assoc of Northern NJ; Carol G. Simon Canc Ctr', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43219', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mark H. Zangmeister Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45429', 'city': 'Kettering', 'state': 'Ohio', 'country': 'United States', 'facility': 'Kettering Medical Center', 'geoPoint': {'lat': 39.6895, 'lon': -84.16883}}, {'zip': '73142', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'INTEGRIS Cancer Inst of OK', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97401-8122', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Willamette Valley Cancer Ctr - 520 Country Club', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology-Medical City Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology - Dallas Presbyterian Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76177', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'US Oncology Research Pharm.', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '75090-0504', 'city': 'Sherman', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Cancer Center - Sherman', 'geoPoint': {'lat': 33.63566, 'lon': -96.60888}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Cancer Specialists, PC', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '24014', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'SW Virginia Hem Onc', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'zip': '22601', 'city': 'Winchester', 'state': 'Virginia', 'country': 'United States', 'facility': 'Shenandoah Oncology Associates', 'geoPoint': {'lat': 39.18566, 'lon': -78.16333}}, {'zip': '98684', 'city': 'Vancouver', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Cancer Specialists - Vancouver', 'geoPoint': {'lat': 45.63873, 'lon': -122.66149}}, {'zip': '98902', 'city': 'Yakima', 'state': 'Washington', 'country': 'United States', 'facility': 'Yakima Valley Memorial Hospital/North Star Lodge', 'geoPoint': {'lat': 46.60207, 'lon': -120.5059}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}