Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-26 @ 8:43 AM
Study NCT ID:
NCT01010061
Status:
COMPLETED
Last Update Posted:
2018-09-14
First Post:
2009-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China']}, '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': 'D000069283', 'term': 'Rituximab'}, {'id': 'D002699', 'term': 'Chlorambucil'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffman-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Randomization to clinical cutoff (median observation 42 months)', 'description': 'Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Obinutuzumab + Chlorambucil (GClb)', 'description': 'Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \\[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).', 'otherNumAtRisk': 241, 'otherNumAffected': 215, 'seriousNumAtRisk': 241, 'seriousNumAffected': 113}, {'id': 'EG001', 'title': 'Chlorambucil (Clb)', 'description': 'Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.', 'otherNumAtRisk': 116, 'otherNumAffected': 89, 'seriousNumAtRisk': 116, 'seriousNumAffected': 45}, {'id': 'EG002', 'title': 'Crossover Subjects: Obinutuzumab + Chlorambucil (GClb)', 'description': 'Subjects in Clb arm who progressed during/within 6 months after end of Clb treatment had opportunity to cross over to GClb arm at discretion of investigator. Subjects received 1000 mg obinutuzumab IV infusion, on Day 1 \\[First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\\], 8 and 15 in Cycle 1 and Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 milligram per kilogram of body weight (mg/kg) orally on Day 1 and 15 of each 28-day cycle (6 Cycles).', 'otherNumAtRisk': 30, 'otherNumAffected': 23, 'seriousNumAtRisk': 30, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 147}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 15}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral Upper Respiratory Tract Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Neutropenic sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Liver abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dacryocystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Infective exacerbation of bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intervertebral discitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Neutropenic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ophthalmic herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Stenotrophomonas sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Superinfection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fracture displacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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{'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Central nervous system haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Capillary leak syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diabetic macroangiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dry gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tumour lysis syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cystitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hereditary non-polyposis colorectal cancer syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Phimosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Prostatic obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Testicular hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fracture treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Radius Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Basosquamous Carcinoma of Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cholangiocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastric Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Skin Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': "Bowen's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lung Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab + Chlorambucil (GClb)', 'description': 'Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \\[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).'}, {'id': 'OG001', 'title': 'Chlorambucil (Clb)', 'description': 'Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000', 'lowerLimit': '26.5', 'upperLimit': '35.6'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '11.3'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '0.16', 'ciUpperLimit': '0.28', 'pValueComment': 'Type I error controlled through closed test procedure.', 'estimateComment': 'Stratified by Binet stage at Baseline.', 'statisticalMethod': 'Log Rank, Stratified', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)', 'description': 'PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the investigator. Progressive disease (PD) required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (\\>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels \\>20 g/L or \\<10 g/dL or a decrease of platelet counts \\>50% or \\<100 x 10\\^9/L or by a decrease of neutrophil counts \\>50% or \\<1.0 x 10\\^9/L).', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population included all randomized participants. Patients without PFS events were censored.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Progression Free Survival Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab + Chlorambucil (GClb)', 'description': 'Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \\[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).'}, {'id': 'OG001', 'title': 'Chlorambucil (Clb)', 'description': 'Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000'}, {'value': '90.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)', 'description': 'Percentage of Participants with Progression Free Survival Events: disease progression, relapse, or death.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival Based on Independent Review Committee (IRC) Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab + Chlorambucil (GClb)', 'description': 'Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \\[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).'}, {'id': 'OG001', 'title': 'Chlorambucil (Clb)', 'description': 'Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.2', 'groupId': 'OG000', 'lowerLimit': '23.5', 'upperLimit': '33.0'}, {'value': '11.2', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': '12.1'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '0.14', 'ciUpperLimit': '0.27', 'estimateComment': 'Stratified by Binet stage at Baseline.', 'statisticalMethod': 'Log Rank, Stratified', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to clinical cutoff date of 9 May 2013 (median observation 22.8 months)', 'description': 'PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by Independent Review Committee. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (\\>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels \\>20 g/L or \\<10 g/dL or a decrease of platelet counts \\>50% or \\<100 x 10\\^9/L or by a decrease of neutrophil counts \\>50% or \\<1.0 x 10\\^9/L).', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population included all randomized participants. Patients without PFS events were censored.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab + Chlorambucil (GClb)', 'description': 'Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \\[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).'}, {'id': 'OG001', 'title': 'Chlorambucil (Clb)', 'description': 'Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.4', 'groupId': 'OG000'}, {'value': '76.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to clinical cutoff date of 9 May 2013 (median observation 22.8 months)', 'description': 'Percentage of Participants with Progression Free Survival Events: progression, relapse, or death from any cause as assessed by an Independent Review Committee.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population included all randomized participants. Participants without PFS events were censored.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With End of Treatment Response (EOTR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab + Chlorambucil (GClb)', 'description': 'Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \\[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).'}, {'id': 'OG001', 'title': 'Chlorambucil (Clb)', 'description': 'Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.'}], 'classes': [{'title': 'Complete Response (CR)', 'categories': [{'measurements': [{'value': '17.2', 'groupId': 'OG000', 'lowerLimit': '12.7', 'upperLimit': '22.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Complete Response incomplete (CRi)', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '7.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Partial Response (PR)', 'categories': [{'measurements': [{'value': '48.3', 'groupId': 'OG000', 'lowerLimit': '41.8', 'upperLimit': '54.9'}, {'value': '28.8', 'groupId': 'OG001', 'lowerLimit': '20.8', 'upperLimit': '37.9'}]}]}, {'title': 'Nodular Partial Response (nPR)', 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '11.7'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '7.3'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '8.6'}, {'value': '22.9', 'groupId': 'OG001', 'lowerLimit': '15.7', 'upperLimit': '31.5'}]}]}, {'title': 'Progressive Disease', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '7.6'}, {'value': '28.8', 'groupId': 'OG001', 'lowerLimit': '20.8', 'upperLimit': '37.9'}]}]}, {'title': 'No Response Assessment', 'categories': [{'measurements': [{'value': '13.4', 'comment': '95% CI not estimated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '16.9', 'comment': '95% CI not estimated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)', 'description': 'EOTR was the first response assessment 56 days from the last dose according to the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) guidelines. CR required: Peripheral blood lymphocytes below 4 x 10\\^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils \\>1.5 x 10\\^9/L, Platelets \\>100 x 10\\^9/L, Hemoglobin \\>11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils \\>1.5 x 10\\^9/ or ≥50% increase, Platelets \\>100 x 10\\^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Best Overall Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab + Chlorambucil (GClb)', 'description': 'Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \\[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).'}, {'id': 'OG001', 'title': 'Chlorambucil (Clb)', 'description': 'Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.'}], 'classes': [{'title': 'Complete Response (CR)', 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000', 'lowerLimit': '21.0', 'upperLimit': '32.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3.1'}]}]}, {'title': 'Complete Response incomplete (CRi)', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '5.4'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '6'}]}]}, {'title': 'Partial Response (PR)', 'categories': [{'measurements': [{'value': '47.1', 'groupId': 'OG000', 'lowerLimit': '40.6', 'upperLimit': '53.6'}, {'value': '31.4', 'groupId': 'OG001', 'lowerLimit': '23.1', 'upperLimit': '40.5'}]}]}, {'title': 'Nodular Partial Response (nPR)', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '4.8'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3.1'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '7.6'}, {'value': '21.2', 'groupId': 'OG001', 'lowerLimit': '14.2', 'upperLimit': '29.7'}]}]}, {'title': 'Progressive Disease', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '7.6'}, {'value': '28.8', 'groupId': 'OG001', 'lowerLimit': '20.8', 'upperLimit': '37.9'}]}]}, {'title': 'No Response Assessment', 'categories': [{'measurements': [{'value': '13.4', 'comment': '95% CI was not estimated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '16.9', 'comment': '95% CI was not estimated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '45.1', 'ciLowerLimit': '34.7', 'ciUpperLimit': '55.5', 'groupDescription': 'Includes subjects with best overall response: CR, CRi, PR or nPR.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)', 'description': 'Best overall response according to IWCLL guidelines was defined as the percentage of patients with CR, CRi,PR or nPR. CR required all of the following: Peripheral blood lymphocytes below 4 x 10\\^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils \\>1.5 x 10\\^9/L, Platelets \\>100 x 10\\^9/L, Hemoglobin \\>11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils \\>1.5 x 10\\^9/ or ≥50% increase, Platelets \\>100 x 10\\^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.'}, {'type': 'SECONDARY', 'title': 'Event Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab + Chlorambucil (GClb)', 'description': 'Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \\[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).'}, {'id': 'OG001', 'title': 'Chlorambucil (Clb)', 'description': 'Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.7', 'groupId': 'OG000', 'lowerLimit': '23.9', 'upperLimit': '32.9'}, {'value': '10.8', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '11.1'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '0.15', 'ciUpperLimit': '0.26', 'estimateComment': 'Stratified by Binet stage at Baseline.', 'statisticalMethod': 'Log Rank, Stratified', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)', 'description': 'Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy. Progressive disease as per IWCLL criteria required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (\\>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels \\>20 g/L or \\<10 g/dL or a decrease of platelet counts \\>50% or \\<100 x 10\\^9/L or by a decrease of neutrophil counts \\>50% or \\<1.0 x 10\\^9/L).', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population included all randomized participants. Patients without EFS events were censored.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab + Chlorambucil (GClb)', 'description': 'Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \\[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).'}, {'id': 'OG001', 'title': 'Chlorambucil (Clb)', 'description': 'Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median survival time and upper limit of 95% CI could not be estimated due to a low number of deaths.', 'groupId': 'OG000', 'lowerLimit': '74.2', 'upperLimit': 'NA'}, {'value': '66.7', 'comment': 'The upper limit of 95% CI could not be estimated due to a low number of deaths.', 'groupId': 'OG001', 'lowerLimit': '50.9', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0196', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.94', 'statisticalMethod': 'Log Rank, Stratified', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)', 'description': 'Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population included all randomized participants. Patients without OS events were censored.'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab + Chlorambucil (GClb)', 'description': 'Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \\[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).'}, {'id': 'OG001', 'title': 'Chlorambucil (Clb)', 'description': 'Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.8', 'groupId': 'OG000', 'lowerLimit': '22.1', 'upperLimit': '33.5'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '6.7'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (stratified)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '0.13', 'ciUpperLimit': '0.28', 'statisticalMethod': 'Log Rank, Stratified', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by Binet stage at Baseline.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)', 'description': 'Duration of Response was defined as the date the response \\[either Complete Response (CR) or Partial Response (PR)\\] was first recorded until the date of Disease Progression or death due to any cause. Response was assessed according IWCLL guidelines.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants) with CR or PR. Participants without response were censored.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Molecular Remission at the End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab + Chlorambucil (GClb)', 'description': 'Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \\[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).'}, {'id': 'OG001', 'title': 'Chlorambucil (Clb)', 'description': 'Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '18.9', 'upperLimit': '32.6'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)', 'description': 'Molecular remission was defined as a minimal residual disease (MRD)-negative result at the end of treatment (assessment that occurred between 56 days and 6 months of last treatment). Molecular remission was assessed for all patients using a blood sample. Additionally, a bone marrow sample was obtained from patients whom the investigator assumed to have a complete response, consistent with the IWCLL guidelines. A combined analysis of blood and bone marrow results was conducted. A patient was considered MRD negative if result was less than 1 chronic lymphocytic leukemia (CLL) cell in 10000 leukocytes (MRD value \\< 0.0001) based on the method of allele specific polymerase chain reaction (ASO-PCR).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.'}, {'type': 'SECONDARY', 'title': 'Time to Re-Treatment/New-antileukemic Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab + Chlorambucil (GClb)', 'description': 'Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \\[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).'}, {'id': 'OG001', 'title': 'Chlorambucil (Clb)', 'description': 'Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.7', 'comment': 'The upper level of the 95% CI was not reached.', 'groupId': 'OG000', 'lowerLimit': '47.4', 'upperLimit': 'NA'}, {'value': '15.1', 'groupId': 'OG001', 'lowerLimit': '11.7', 'upperLimit': '18.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (stratified)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '0.19', 'ciUpperLimit': '0.35', 'statisticalMethod': 'Log Rank, Stratified', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by Binet stage at Baseline.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)', 'description': 'Time to re-treatment/new anti-leukemic therapy was defined as time between the date of randomization and the date of first intake of re-treatment or new anti-leukemic therapy.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population included all randomized participants. Participants without events (re-treatment or new anti-leukemic therapy) were censored.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab + Chlorambucil (GClb)', 'description': 'Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \\[First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).'}], 'classes': [{'title': 'Post-dose Cycle 1 (n=201)', 'categories': [{'measurements': [{'value': '247', 'spread': '41.6', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose Cycle 2 (n=198)', 'categories': [{'measurements': [{'value': '227', 'spread': '57.9', 'groupId': 'OG000'}]}]}, {'title': 'Post-dose Cycle 2 (n=197)', 'categories': [{'measurements': [{'value': '587', 'spread': '36.5', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose Cycle 3 (n=193)', 'categories': [{'measurements': [{'value': '165', 'spread': '68.7', 'groupId': 'OG000'}]}]}, {'title': 'Post-dose Cycle 3 (n=192)', 'categories': [{'measurements': [{'value': '527', 'spread': '39.7', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose Cycle 4 (n=191)', 'categories': [{'measurements': [{'value': '156', 'spread': '74.3', 'groupId': 'OG000'}]}]}, {'title': 'Post-dose Cycle 4 (n=189)', 'categories': [{'measurements': [{'value': '535', 'spread': '41.0', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose Cycle 5 (n=185)', 'categories': [{'measurements': [{'value': '163', 'spread': '72.4', 'groupId': 'OG000'}]}]}, {'title': 'Post-dose Cycle 5 (n=181)', 'categories': [{'measurements': [{'value': '534', 'spread': '39.1', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose Cycle 6 (n=185)', 'categories': [{'measurements': [{'value': '181', 'spread': '69.0', 'groupId': 'OG000'}]}]}, {'title': 'Post-dose Cycle 6 (n=183)', 'categories': [{'measurements': [{'value': '525', 'spread': '39.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre- and post-dose sampling on day 1 of cycles 1-6 (Up to 26.8 months)', 'description': 'Blood samples were collected from all patients allocated to the GClb treatment arm pre- and post-dose Day 1 of Cycles 1 to 6 and were sent to a laboratory. The concentration of obinutzumab in serum was determined using a validated enzyme-linked immunosorbent assay (ELISA) and was reported in micrograms/milliliter (μg/mL).', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population includes all participants with PK data available at the given time-point.'}, {'type': 'SECONDARY', 'title': 'European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab + Chlorambucil (GClb)', 'description': 'Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \\[First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).'}, {'id': 'OG001', 'title': 'Chlorambucil (Clb)', 'description': 'Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.'}], 'classes': [{'title': 'Appetite Loss Scale: Baseline (n=226, 111)', 'categories': [{'measurements': [{'value': '18.1', 'spread': '28.46', 'groupId': 'OG000'}, {'value': '19.8', 'spread': '29.26', 'groupId': 'OG001'}]}]}, {'title': 'Appetite Loss Scale: Cy4D1 (n=189, 92)', 'categories': [{'measurements': [{'value': '10.2', 'spread': '21.77', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '24.36', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive Functioning Scale: Baseline (n=227, 111)', 'categories': [{'measurements': [{'value': '80.6', 'spread': '21.35', 'groupId': 'OG000'}, {'value': '81.8', 'spread': '22.76', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive Functioning Scale:Cy4D1 (n=190,93)', 'categories': [{'measurements': [{'value': '83.9', 'spread': '20.31', 'groupId': 'OG000'}, {'value': '85.8', 'spread': '18.54', 'groupId': 'OG001'}]}]}, {'title': 'Constipation Scale: Baseline (n=225, 111)', 'categories': [{'measurements': [{'value': '14.8', 'spread': '23.94', 'groupId': 'OG000'}, {'value': '16.8', 'spread': '26.92', 'groupId': 'OG001'}]}]}, {'title': 'Constipation Scale: Cy4D1 (n=188, 93)', 'categories': [{'measurements': [{'value': '15.1', 'spread': '25.16', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '23.53', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea Scale: Baseline (n=226, 110)', 'categories': [{'measurements': [{'value': '9.3', 'spread': '20.05', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '18.98', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea Scale: Cy4D1 (n=189, 93)', 'categories': [{'measurements': [{'value': '9.3', 'spread': '19.47', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '14.95', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnoea Scale: Baseline (n=225, 109)', 'categories': [{'measurements': [{'value': '27.1', 'spread': '29.89', 'groupId': 'OG000'}, {'value': '23.9', 'spread': '27.63', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnoea: Cy4D1 (n=189, 91)', 'categories': [{'measurements': [{'value': '15.9', 'spread': '23.71', 'groupId': 'OG000'}, {'value': '22.3', 'spread': '26.78', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Functioning Scale: Baseline (n=226, 111)', 'categories': [{'measurements': [{'value': '73.8', 'spread': '23.45', 'groupId': 'OG000'}, {'value': '72.9', 'spread': '25.7', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Functioning Scale: Cy4D1(n=190,93)', 'categories': [{'measurements': [{'value': '82.5', 'spread': '18.62', 'groupId': 'OG000'}, {'value': '80.6', 'spread': '18.48', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue Scale: Baseline (n=226, 111)', 'categories': [{'measurements': [{'value': '38', 'spread': '25.72', 'groupId': 'OG000'}, {'value': '36.9', 'spread': '27.01', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue Scale: Cy4D1(n=189, 93)', 'categories': [{'measurements': [{'value': '29.2', 'spread': '20.39', 'groupId': 'OG000'}, {'value': '30.8', 'spread': '23.00', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Scale: Baseline (n=224,110)', 'categories': [{'measurements': [{'value': '8.9', 'spread': '20.69', 'groupId': 'OG000'}, {'value': '13.6', 'spread': '25.26', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulty Scale: Cy4D1(n=189,93)', 'categories': [{'measurements': [{'value': '7.4', 'spread': '17.64', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '19.88', 'groupId': 'OG001'}]}]}, {'title': 'Nausea, Vomiting Scale: Baseline (n=227, 111)', 'categories': [{'measurements': [{'value': '5', 'spread': '11.18', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '18.49', 'groupId': 'OG001'}]}]}, {'title': 'Nausea, Vomiting Scale: Cy4D1 (n=189,93)', 'categories': [{'measurements': [{'value': '5.5', 'spread': '11.51', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '17.81', 'groupId': 'OG001'}]}]}, {'title': 'Pain scale: Baseline (n=228, 111)', 'categories': [{'measurements': [{'value': '22.9', 'spread': '27.57', 'groupId': 'OG000'}, {'value': '21.5', 'spread': '25.66', 'groupId': 'OG001'}]}]}, {'title': 'Pain scale: Cy4D1 (n=190, 93)', 'categories': [{'measurements': [{'value': '17.9', 'spread': '24.09', 'groupId': 'OG000'}, {'value': '17.7', 'spread': '25.98', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Scale: Baseline (n=228, 111)', 'categories': [{'measurements': [{'value': '73.7', 'spread': '19.86', 'groupId': 'OG000'}, {'value': '77.3', 'spread': '18.87', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Scale: Cy4D1(n=189,93)', 'categories': [{'measurements': [{'value': '78.6', 'spread': '18.71', 'groupId': 'OG000'}, {'value': '80.9', 'spread': '16.24', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status Scale: Baseline (n=226, 111)', 'categories': [{'measurements': [{'value': '58.4', 'spread': '22.8', 'groupId': 'OG000'}, {'value': '57.4', 'spread': '22.9', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status Scale: Cy4D1(n=189,93)', 'categories': [{'measurements': [{'value': '66.7', 'spread': '20.03', 'groupId': 'OG000'}, {'value': '63.4', 'spread': '20.56', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Scale: Baseline(n=227,110)', 'categories': [{'measurements': [{'value': '76.1', 'spread': '26.18', 'groupId': 'OG000'}, {'value': '74.7', 'spread': '28.35', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Scale: Cy4D1(n=189,93)', 'categories': [{'measurements': [{'value': '79.7', 'spread': '23.64', 'groupId': 'OG000'}, {'value': '81.5', 'spread': '21.35', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning Scale:Baseline(n=226,110)', 'categories': [{'measurements': [{'value': '86.3', 'spread': '22.52', 'groupId': 'OG000'}, {'value': '83.3', 'spread': '25.34', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning Scale: Cy4D1(n=190,93)', 'categories': [{'measurements': [{'value': '87.8', 'spread': '19.97', 'groupId': 'OG000'}, {'value': '85.5', 'spread': '19.38', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia Scale: Baseline (n=228,111)', 'categories': [{'measurements': [{'value': '29.4', 'spread': '31.12', 'groupId': 'OG000'}, {'value': '31.5', 'spread': '32.98', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia Scale: Cy4D1(n=189,93)', 'categories': [{'measurements': [{'value': '20.6', 'spread': '27.13', 'groupId': 'OG000'}, {'value': '24.4', 'spread': '29.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Cycle 4 Day 1 (Cy4D1)', 'description': 'The EORTC Quality of Life Questionnaire QLQ-C30 was used to assess patient-reported outcomes (PRO) and symptom burden. The QLQ-C30 contains 30 items including the functional scales of physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items) and symptom scales including fatigue (3 items), nausea and vomiting (2 items), and pain (4 items) and six single item scales on dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact. Final scores are transformed such that they range from 0 - 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.', 'unitOfMeasure': 'unit on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Here, n signifies the number of participants who were evaluated for specified categories.'}, {'type': 'SECONDARY', 'title': 'European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obinutuzumab + Chlorambucil (GClb)', 'description': 'Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \\[First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).'}, {'id': 'OG001', 'title': 'Chlorambucil (Clb)', 'description': 'Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.'}], 'classes': [{'title': 'Disease Effects Scale: Baseline (n=209, 102)', 'categories': [{'measurements': [{'value': '23', 'spread': '18.89', 'groupId': 'OG000'}, {'value': '23.7', 'spread': '20.18', 'groupId': 'OG001'}]}]}, {'title': 'Disease Effects Scale: Cy4D1 (n=176, 86)', 'categories': [{'measurements': [{'value': '15.0', 'spread': '15.12', 'groupId': 'OG000'}, {'value': '15.9', 'spread': '14.16', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue Scale: Baseline (n=209, 102)', 'categories': [{'measurements': [{'value': '31.2', 'spread': '25.83', 'groupId': 'OG000'}, {'value': '27.6', 'spread': '24.65', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue Scale: Cy4D1 (n=176, 86)', 'categories': [{'measurements': [{'value': '20.9', 'spread': '21.51', 'groupId': 'OG000'}, {'value': '23.4', 'spread': '22.20', 'groupId': 'OG001'}]}]}, {'title': 'Future Health: Baseline (n=206, 101)', 'categories': [{'measurements': [{'value': '47.7', 'spread': '32.14', 'groupId': 'OG000'}, {'value': '50.8', 'spread': '33.53', 'groupId': 'OG001'}]}]}, {'title': 'Future Health: Cy4D1 (n=175, 86)', 'categories': [{'measurements': [{'value': '29.5', 'spread': '31.74', 'groupId': 'OG000'}, {'value': '39.1', 'spread': '30.33', 'groupId': 'OG001'}]}]}, {'title': 'Infection Scale: Baseline (n=209, 102)', 'categories': [{'measurements': [{'value': '12', 'spread': '15.91', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '17.97', 'groupId': 'OG001'}]}]}, {'title': 'Infection Scale: Cy4D1 (n=176, 86)', 'categories': [{'measurements': [{'value': '8.9', 'spread': '11.65', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '10.70', 'groupId': 'OG001'}]}]}, {'title': 'Social Problems: Baseline (n=206, 100)', 'categories': [{'measurements': [{'value': '24.3', 'spread': '31.99', 'groupId': 'OG000'}, {'value': '26.3', 'spread': '33.26', 'groupId': 'OG001'}]}]}, {'title': 'Social Problems: Cy4D1 (n=175, 85)', 'categories': [{'measurements': [{'value': '19.4', 'spread': '27.75', 'groupId': 'OG000'}, {'value': '22.0', 'spread': '27.00', 'groupId': 'OG001'}]}]}, {'title': 'Treatment Side Effects Scale: Baseline (n=209,102)', 'categories': [{'measurements': [{'value': '19.8', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '17.2', 'spread': '15.27', 'groupId': 'OG001'}]}]}, {'title': 'Treatment Side Effect Scale: Cy4D1(n=176,86)', 'categories': [{'measurements': [{'value': '14.7', 'spread': '14.68', 'groupId': 'OG000'}, {'value': '15.6', 'spread': '16.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Cycle 4 Day 1 (Cy4D1)', 'description': 'EORTC Quality of Life Questionnaire (QLQ-CLL16) module was used to assess patient-reported outcomes and symptom burden. The QLQ-CLL16 module includes three multi-item scales assessing fatigue (2 items), treatment side effects and disease symptoms (8 items), infection (4 items) and two single item scales on social activities and future health worries. Final scores are transformed such that they range from 0 - 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.', 'unitOfMeasure': 'unit on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Here, n signifies the number of participants who were evaluated for specified categories.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Obinutuzumab + Chlorambucil (GClb)', 'description': 'Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \\[First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).'}, {'id': 'FG001', 'title': 'Chlorambucil (Clb)', 'description': 'Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '238'}, {'groupId': 'FG001', 'numSubjects': '118'}]}, {'type': 'Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '236'}, {'groupId': 'FG001', 'numSubjects': '116'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed=Completed treatment.', 'groupId': 'FG000', 'numSubjects': '190'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Adverse Events or Intercurrent Illness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Administrative/Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Refused Treatment/Did Not Cooperate', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Insufficient Therapeutic Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Violation of Selection Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Did Not Receive Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '787 patients were enrolled in the study. Following a 6 patient safety run-in prior to randomization, 781 patients were randomized.', 'preAssignmentDetails': '589 patients were randomized to 1 of 3 treatment groups in 2:2:1 ratio: GClb (n=238), RClb (n=233) or Clb (n=118) in Stage 1 and an additional 192 randomized to GClb or RClb in Stage 2 \\[NCT02053610\\]. Stage 1 was divided for analysis into: Stage 1a (GClb vs Clb) n=356 reported here and Stage 1b (RClb vs Clb) \\[NCT01998880\\] reported separately.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '356', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Obinutuzumab + Chlorambucil (GClb)', 'description': 'Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \\[First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).'}, {'id': 'BG001', 'title': 'Chlorambucil (Clb)', 'description': 'Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '196', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline measures are based on the participants who were included in the Stage 1a analysis.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 787}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-15', 'studyFirstSubmitDate': '2009-11-06', 'resultsFirstSubmitDate': '2013-12-02', 'studyFirstSubmitQcDate': '2009-11-06', 'lastUpdatePostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-02-14', 'studyFirstPostDateStruct': {'date': '2009-11-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)', 'description': 'PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the investigator. Progressive disease (PD) required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (\\>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels \\>20 g/L or \\<10 g/dL or a decrease of platelet counts \\>50% or \\<100 x 10\\^9/L or by a decrease of neutrophil counts \\>50% or \\<1.0 x 10\\^9/L).'}, {'measure': 'Percentage of Participants With Progression Free Survival Events', 'timeFrame': 'Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)', 'description': 'Percentage of Participants with Progression Free Survival Events: disease progression, relapse, or death.'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival Based on Independent Review Committee (IRC) Data', 'timeFrame': 'Randomization to clinical cutoff date of 9 May 2013 (median observation 22.8 months)', 'description': 'PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by Independent Review Committee. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (\\>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels \\>20 g/L or \\<10 g/dL or a decrease of platelet counts \\>50% or \\<100 x 10\\^9/L or by a decrease of neutrophil counts \\>50% or \\<1.0 x 10\\^9/L).'}, {'measure': 'Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data', 'timeFrame': 'Randomization to clinical cutoff date of 9 May 2013 (median observation 22.8 months)', 'description': 'Percentage of Participants with Progression Free Survival Events: progression, relapse, or death from any cause as assessed by an Independent Review Committee.'}, {'measure': 'Percentage of Participants With End of Treatment Response (EOTR)', 'timeFrame': 'Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)', 'description': 'EOTR was the first response assessment 56 days from the last dose according to the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) guidelines. CR required: Peripheral blood lymphocytes below 4 x 10\\^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils \\>1.5 x 10\\^9/L, Platelets \\>100 x 10\\^9/L, Hemoglobin \\>11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils \\>1.5 x 10\\^9/ or ≥50% increase, Platelets \\>100 x 10\\^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.'}, {'measure': 'Percentage of Participants With Best Overall Response', 'timeFrame': 'Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)', 'description': 'Best overall response according to IWCLL guidelines was defined as the percentage of patients with CR, CRi,PR or nPR. CR required all of the following: Peripheral blood lymphocytes below 4 x 10\\^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils \\>1.5 x 10\\^9/L, Platelets \\>100 x 10\\^9/L, Hemoglobin \\>11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils \\>1.5 x 10\\^9/ or ≥50% increase, Platelets \\>100 x 10\\^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.'}, {'measure': 'Event Free Survival', 'timeFrame': 'Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)', 'description': 'Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy. Progressive disease as per IWCLL criteria required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (\\>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels \\>20 g/L or \\<10 g/dL or a decrease of platelet counts \\>50% or \\<100 x 10\\^9/L or by a decrease of neutrophil counts \\>50% or \\<1.0 x 10\\^9/L).'}, {'measure': 'Overall Survival', 'timeFrame': 'Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)', 'description': 'Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause.'}, {'measure': 'Duration of Response', 'timeFrame': 'Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)', 'description': 'Duration of Response was defined as the date the response \\[either Complete Response (CR) or Partial Response (PR)\\] was first recorded until the date of Disease Progression or death due to any cause. Response was assessed according IWCLL guidelines.'}, {'measure': 'Percentage of Participants With Molecular Remission at the End of Treatment', 'timeFrame': 'Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)', 'description': 'Molecular remission was defined as a minimal residual disease (MRD)-negative result at the end of treatment (assessment that occurred between 56 days and 6 months of last treatment). Molecular remission was assessed for all patients using a blood sample. Additionally, a bone marrow sample was obtained from patients whom the investigator assumed to have a complete response, consistent with the IWCLL guidelines. A combined analysis of blood and bone marrow results was conducted. A patient was considered MRD negative if result was less than 1 chronic lymphocytic leukemia (CLL) cell in 10000 leukocytes (MRD value \\< 0.0001) based on the method of allele specific polymerase chain reaction (ASO-PCR).'}, {'measure': 'Time to Re-Treatment/New-antileukemic Therapy', 'timeFrame': 'Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)', 'description': 'Time to re-treatment/new anti-leukemic therapy was defined as time between the date of randomization and the date of first intake of re-treatment or new anti-leukemic therapy.'}, {'measure': 'Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb)', 'timeFrame': 'Pre- and post-dose sampling on day 1 of cycles 1-6 (Up to 26.8 months)', 'description': 'Blood samples were collected from all patients allocated to the GClb treatment arm pre- and post-dose Day 1 of Cycles 1 to 6 and were sent to a laboratory. The concentration of obinutzumab in serum was determined using a validated enzyme-linked immunosorbent assay (ELISA) and was reported in micrograms/milliliter (μg/mL).'}, {'measure': 'European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score', 'timeFrame': 'Baseline and Cycle 4 Day 1 (Cy4D1)', 'description': 'The EORTC Quality of Life Questionnaire QLQ-C30 was used to assess patient-reported outcomes (PRO) and symptom burden. The QLQ-C30 contains 30 items including the functional scales of physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items) and symptom scales including fatigue (3 items), nausea and vomiting (2 items), and pain (4 items) and six single item scales on dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact. Final scores are transformed such that they range from 0 - 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.'}, {'measure': 'European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score', 'timeFrame': 'Baseline and Cycle 4 Day 1 (Cy4D1)', 'description': 'EORTC Quality of Life Questionnaire (QLQ-CLL16) module was used to assess patient-reported outcomes and symptom burden. The QLQ-CLL16 module includes three multi-item scales assessing fatigue (2 items), treatment side effects and disease symptoms (8 items), infection (4 items) and two single item scales on social activities and future health worries. Final scores are transformed such that they range from 0 - 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.'}]}, 'conditionsModule': {'conditions': ['Lymphocytic Leukemia, Chronic']}, 'referencesModule': {'references': [{'pmid': '38620092', 'type': 'DERIVED', 'citation': 'Langerbeins P, Giza A, Robrecht S, Cramer P, von Tresckow J, Al-Sawaf O, Fink AM, Furstenau M, Kutsch N, Simon F, Goede V, Hoechstetter M, Niemann CU, da Cunha-Bang C, Kater A, Dubois J, Gregor M, Staber PB, Tausch E, Schneider C, Stilgenbauer S, Eichhorst B, Fischer K, Hallek M. Reassessing the chronic lymphocytic leukemia International Prognostic Index in the era of targeted therapies. Blood. 2024 Jun 20;143(25):2588-2598. doi: 10.1182/blood.2023022564.'}, {'pmid': '33131249', 'type': 'DERIVED', 'citation': 'Jaramillo S, Agathangelidis A, Schneider C, Bahlo J, Robrecht S, Tausch E, Bloehdorn J, Hoechstetter M, Fischer K, Eichhorst B, Goede V, Hallek M, Dohner H, Rosenquist R, Ghia P, Stamatopoulos K, Stilgenbauer S. Prognostic impact of prevalent chronic lymphocytic leukemia stereotyped subsets: analysis within prospective clinical trials of the German CLL Study Group (GCLLSG). Haematologica. 2020 Nov 1;105(11):2598-2607. doi: 10.3324/haematol.2019.231027.'}, {'pmid': '31050355', 'type': 'DERIVED', 'citation': 'Gibiansky E, Gibiansky L, Buchheit V, Frey N, Brewster M, Fingerle-Rowson G, Jamois C. Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study. Br J Clin Pharmacol. 2019 Sep;85(9):1935-1945. doi: 10.1111/bcp.13974. Epub 2019 Jul 12.'}, {'pmid': '24401022', 'type': 'DERIVED', 'citation': 'Goede V, Fischer K, Busch R, Engelke A, Eichhorst B, Wendtner CM, Chagorova T, de la Serna J, Dilhuydy MS, Illmer T, Opat S, Owen CJ, Samoylova O, Kreuzer KA, Stilgenbauer S, Dohner H, Langerak AW, Ritgen M, Kneba M, Asikanius E, Humphrey K, Wenger M, Hallek M. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. N Engl J Med. 2014 Mar 20;370(12):1101-10. doi: 10.1056/NEJMoa1313984. Epub 2014 Jan 8.'}]}, 'descriptionModule': {'briefSummary': 'This open-label, randomized, 3-arm study will evaluate the efficacy and safety of obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m\\^2 cycle 1, 500 mg/m\\^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is \\>6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.', 'detailedDescription': 'Protocol BO21004 is divided into 3 separate Unique Protocol IDs for reporting results on clinicaltrials.gov because there are 3 separate primary analyses conducted at different time-points.\n\n* BO21004 (Stage 1a) \\[NCT01010061\\] includes the analysis of 2 of the 3 arms obinutuzumab plus chlorambucil (Glb) compared to chlorambucil (Clb) reported here.\n* BO21004 (Stage 1b) \\[NCT01998880\\] includes the analysis of 2 of the 3 arms rituximab plus chlorambucil (RClb) compared to chlorambucil (Clb) reported separately.\n* BO21004 (Stage 2) \\[NCT02053610\\] includes the analysis of 2 of the 3 arms obinutuzumab plus chlorambucil (Glb) compared to rituximab plus chlorambucil (RClb) reported separately.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults \\>/=18 years\n* Documented Cluster of Differentiation Antigen 20 (CD20) + B-Cell Chronic Lymphocytic Lymphoma (B-CLL)\n* Previously untreated Chronic Lymphocytic Leukemia (CLL) requiring treatment according to the National Cancer Institute (NCI) criteria\n* Total Cumulative Illness Rating Scale (CIRS) \\> 6 and/or creatinine clearance \\< 70 ml/min\n\nExclusion Criteria:\n\n* Prior CLL therapy\n* Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)\n* History of other malignancy unless the malignancy has been in remission without treatment for \\>/=2 years prior to enrolment, and except for carcinoma in situ of the cervix, basal or squamous cell skin cancer, surgically treated low-grade prostate cancer, or ductal carcinoma in situ (DCIS) of the breast treated with lymphectomy alone\n* Positive hepatitis serology (HBV, HCV) or positive HIV or Human T Cell Leukemia Virus (HTLV) testing\n* Patients with active infection requiring systemic treatment"}, 'identificationModule': {'nctId': 'NCT01010061', 'briefTitle': 'CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)', 'nctIdAliases': ['NCT02035462'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Open-label, Multi-center, Three Arm Randomized Study to Investigate the Safety and Efficacy on Progression-free Survival of RO5072759 + Chlorambucil (GClb) Compared to Rituximab + Chlorambucil (RClb) or Chlorambucil (Clb) Alone in Previously Untreated CLL Patients With Comorbidities.', 'orgStudyIdInfo': {'id': 'BO21004 (Stage 1a)'}, 'secondaryIdInfos': [{'id': '2009-012476-28; CLL11'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'obinutuzumab + chlorambucil (GClb)', 'description': 'Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \\[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).', 'interventionNames': ['Drug: obinutuzumab', 'Drug: chlorambucil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'rituximab + chlorambucil (RClb)', 'description': 'Participants received 375 mg/m\\^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m\\^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).', 'interventionNames': ['Drug: rituximab', 'Drug: chlorambucil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorambucil (Clb)', 'description': 'Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.', 'interventionNames': ['Drug: chlorambucil']}], 'interventions': [{'name': 'obinutuzumab', 'type': 'DRUG', 'otherNames': ['RO5072759', 'GA101', 'GAZYVA®'], 'description': '1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \\[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles).', 'armGroupLabels': ['obinutuzumab + chlorambucil (GClb)']}, {'name': 'rituximab', 'type': 'DRUG', 'otherNames': ['Rituxan®', 'MabThera®'], 'description': '375 mg/m\\^2 rituximab intravenous (IV) infusion on Day 1 of Cycle 1 (Cycle duration is 28 days) then 500 mg/m\\^2 IV infusions on Day 1 of Cycles 2-6.', 'armGroupLabels': ['rituximab + chlorambucil (RClb)']}, {'name': 'chlorambucil', 'type': 'DRUG', 'description': 'Chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle.', 'armGroupLabels': ['Chlorambucil (Clb)', 'obinutuzumab + chlorambucil (GClb)', 'rituximab + chlorambucil (RClb)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '54311', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}, {'zip': '53188', 'city': 'Waukesha', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.01168, 'lon': -88.23148}}, {'zip': '1406', 'city': 'Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '1425', 'city': 'Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1114AAN', 'city': 'Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1180AAX', 'city': 'Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1221ADC', 'city': 'Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1431FWO', 'city': 'Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '2000', 'city': 'Rosario', 'country': 'Argentina', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '5011', 'city': 'Adelaide', 'state': 'New South Wales', 'country': 'Australia'}, {'zip': '2250', 'city': 'Gosford', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -33.4244, 'lon': 151.34399}}, {'zip': '2217', 'city': 'Kogarah', 'state': 'New South Wales', 'country': 'Australia', 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