Viewing Study NCT01332968

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Ignite Creation Date: 2025-12-24 @ 5:59 PM
Ignite Modification Date: 2025-12-29 @ 12:11 AM
Study NCT ID: NCT01332968
Status: COMPLETED
Last Update Posted: 2022-08-11
First Post: 2011-04-08
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C543332', 'term': 'obinutuzumab'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D000069461', 'term': 'Bendamustine Hydrochloride'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 10 years', 'description': 'The safety analysis population included all participants who received any amount of any study drug and participants were analyzed according to the treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.', 'otherNumAtRisk': 692, 'deathsNumAtRisk': 692, 'otherNumAffected': 675, 'seriousNumAtRisk': 692, 'deathsNumAffected': 111, 'seriousNumAffected': 309}, {'id': 'EG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.', 'otherNumAtRisk': 698, 'deathsNumAtRisk': 698, 'otherNumAffected': 690, 'seriousNumAtRisk': 698, 'deathsNumAffected': 104, 'seriousNumAffected': 361}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 95, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 88, 'numAffected': 75}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 267, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 222, 'numAffected': 87}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 777, 'numAffected': 307}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 885, 'numAffected': 348}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 79, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 150, 'numAffected': 90}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 95, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 84, 'numAffected': 69}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 60, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 64, 'numAffected': 57}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 301, 'numAffected': 221}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 326, 'numAffected': 249}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 253, 'numAffected': 168}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 318, 'numAffected': 207}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DRY MOUTH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 40, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 56, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 82, 'numAffected': 65}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 577, 'numAffected': 338}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 594, 'numAffected': 354}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'STOMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 71, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 72, 'numAffected': 54}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 211, 'numAffected': 151}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 242, 'numAffected': 182}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 55, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 56, 'numAffected': 47}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CHEST DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 43, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 45, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CHILLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 99, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 172, 'numAffected': 126}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 392, 'numAffected': 277}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 390, 'numAffected': 275}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INFLUENZA LIKE ILLNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 36, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 38, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MUCOSAL INFLAMMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 55, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 41, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 47, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 50, 'numAffected': 46}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 40, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 28, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 231, 'numAffected': 150}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 277, 'numAffected': 200}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 53, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 69, 'numAffected': 47}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CONJUNCTIVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 30, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 42, 'numAffected': 35}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HERPES ZOSTER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 46, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 75, 'numAffected': 70}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'LOWER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 105, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 97, 'numAffected': 59}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 224, 'numAffected': 143}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 200, 'numAffected': 135}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ORAL HERPES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 48, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 54, 'numAffected': 46}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 59, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 63, 'numAffected': 47}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 43, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 67, 'numAffected': 39}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'RHINITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 49, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 71, 'numAffected': 59}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 58, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 92, 'numAffected': 68}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 189, 'numAffected': 132}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 217, 'numAffected': 153}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 100, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 111, 'numAffected': 75}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INFUSION RELATED REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 569, 'numAffected': 347}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 699, 'numAffected': 416}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 49, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 37, 'numAffected': 35}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 103, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 114, 'numAffected': 98}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HYPOKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 43, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 72, 'numAffected': 48}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 160, 'numAffected': 127}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 180, 'numAffected': 144}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 143, 'numAffected': 115}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 127, 'numAffected': 99}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'BONE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 56, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 46, 'numAffected': 40}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 49, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 46, 'numAffected': 40}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 43, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 63, 'numAffected': 53}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 79, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 75, 'numAffected': 66}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 69, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 88, 'numAffected': 75}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DYSGEUSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 44, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 42, 'numAffected': 38}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 185, 'numAffected': 123}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 229, 'numAffected': 155}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NEUROPATHY PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 52, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 62, 'numAffected': 51}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PARAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 68, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 71, 'numAffected': 62}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PERIPHERAL SENSORY NEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 50, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 68, 'numAffected': 59}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 31, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 47, 'numAffected': 44}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 98, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 131, 'numAffected': 113}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 248, 'numAffected': 185}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 305, 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{'term': 'GASTRIC ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'GASTRITIS EROSIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'GASTROENTERITIS EOSINOPHILIC', 'stats': [{'groupId': 'EG000', 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{'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HIATUS HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ILEUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INGUINAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INTESTINAL ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INTESTINAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INTESTINAL POLYP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INTESTINAL VILLI ATROPHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'LARGE INTESTINAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'LARGE INTESTINE POLYP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MELAENA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': "MIKULICZ'S SYNDROME", 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MOUTH ULCERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'OBSTRUCTIVE PANCREATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PANCREATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PANCREATITIS ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 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{'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SWOLLEN TONGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'UMBILICAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'UPPER GASTROINTESTINAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CHILLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CYST RUPTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DEATH', 'stats': 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{'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ILL-DEFINED DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INFLUENZA LIKE ILLNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INFUSION SITE EXTRAVASATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 43, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'STENT-GRAFT ENDOLEAK', 'stats': 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infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ARTHRITIS BACTERIAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ARTHRITIS INFECTIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ATYPICAL PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 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{'term': 'BREAST ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CAMPYLOBACTER INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CATHETER SITE CELLULITIS', 'stats': [{'groupId': 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{'term': 'HERPES ZOSTER INFECTION NEUROLOGICAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HERPES ZOSTER OTICUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INFECTED CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INFECTION', 'stats': 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0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MUCOSAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NEUROBORRELIOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NEUTROPENIC INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NEUTROPENIC SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'OESOPHAGEAL CANDIDIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'OESOPHAGEAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 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'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 18, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SEPTIC SHOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 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24.0'}, {'term': 'STAPHYLOCOCCAL BACTERAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'STAPHYLOCOCCAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SUBCUTANEOUS ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'TUBERCULOSIS', 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'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'FOOT FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HAND FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HUMERUS FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INFUSION RELATED REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 42, 'numAffected': 36}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'LIGAMENT SPRAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'LUMBAR VERTEBRAL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 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'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PNEUMOTHORAX TRAUMATIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'POST PROCEDURAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SEROMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 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'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'BLOOD CREATININE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS WORSENED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HEPATIC ENZYME INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INTERNATIONAL NORMALISED RATIO INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'RESPIROVIRUS TEST POSITIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'WHITE BLOOD CELLS URINE POSITIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DIABETES MELLITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'FLUID OVERLOAD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HYPERCALCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HYPERGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HYPOKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HYPONATRAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'TUMOUR LYSIS SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ARTHROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'FLANK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HAEMARTHROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INTERVERTEBRAL DISC PROTRUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MUSCULAR WEAKNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MYOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MYOSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NECK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'OSTEITIS DEFORMANS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PATHOLOGICAL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ROTATOR CUFF SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SERONEGATIVE ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SPINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SPINAL STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SYNOVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'TEMPOROMANDIBULAR JOINT SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ACOUSTIC NEUROMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ACUTE LYMPHOCYTIC LEUKAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ACUTE MYELOID LEUKAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ADENOCARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ADENOCARCINOMA METASTATIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ADENOCARCINOMA OF COLON', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'BASAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'BENIGN LARYNGEAL NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'BLADDER TRANSITIONAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'BLADDER TRANSITIONAL CELL CARCINOMA METASTATIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': "BOWEN'S DISEASE", 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'BREAST CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CANCER PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CHOLANGIOCARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COLON CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COLORECTAL CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DUCTAL ADENOCARCINOMA OF PANCREAS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'GASTRIC ADENOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'GASTRIC CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'GASTROINTESTINAL NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HEPATIC CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': "HODGKIN'S DISEASE", 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': "HODGKIN'S DISEASE NODULAR SCLEROSIS", 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': "HODGKIN'S DISEASE STAGE II", 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HORMONE RECEPTOR POSITIVE BREAST CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INTRADUCTAL PROLIFERATIVE BREAST LESION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INTRAOCULAR MELANOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INVASIVE DUCTAL BREAST CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'KERATOACANTHOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'LARYNGEAL SQUAMOUS CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'LENTIGO MALIGNA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'LUNG ADENOCARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'LUNG NEOPLASM MALIGNANT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MALIGNANT MELANOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MENINGIOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MYELODYSPLASTIC SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NEUROENDOCRINE CARCINOMA OF THE SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': "NON-HODGKIN'S LYMPHOMA", 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NON-SMALL CELL LUNG CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NON-SMALL CELL LUNG CANCER STAGE IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'OESOPHAGEAL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PANCREATIC CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PAPILLARY THYROID CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PITUITARY TUMOUR BENIGN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PROSTATE CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'RECTAL ADENOCARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'RENAL CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'RENAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SCHWANNOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SQUAMOUS CELL BREAST CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SQUAMOUS CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SQUAMOUS CELL CARCINOMA OF SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'THYROID ADENOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'TRANSITIONAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'TUMOUR FLARE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'UTERINE CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'VULVOVAGINAL WARTS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'AMYOTROPHIC LATERAL SCLEROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ATAXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'BRACHIAL PLEXOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CAROTID ARTERY STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CEREBRAL DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CEREBRAL HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CEREBRAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CEREBRAL ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CEREBROVASCULAR ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DEMENTIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DIZZINESS POSTURAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DYSDIADOCHOKINESIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ENCEPHALOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'EPILEPSY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'FACIAL PARALYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HAEMORRHAGE INTRACRANIAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HAEMORRHAGIC STROKE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HYPERAMMONAEMIC ENCEPHALOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HYPOTONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ISCHAEMIC STROKE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'LETHARGY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'LOSS OF CONSCIOUSNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MONOPARESIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NERVOUS SYSTEM DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NEURALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NEUROPATHY PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ORTHOSTATIC INTOLERANCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ORTHOSTATIC TREMOR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': "PARKINSON'S DISEASE", 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'POLYNEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PRESYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SEIZURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SPINAL CORD COMPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SUBARACHNOID HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'TRANSIENT ISCHAEMIC ATTACK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 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thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ACTINIC KERATOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DERMATITIS CONTACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DERMATITIS EXFOLIATIVE GENERALISED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DRUG ERUPTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'RASH MACULO-PAPULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'URTICARIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'AXILLARY VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CIRCULATORY COLLAPSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HYPERTENSIVE CRISIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HYPERTENSIVE URGENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PELVIC VENOUS THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PERIPHERAL ARTERY ANEURYSM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PERIPHERAL ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 692, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 698, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '601', 'groupId': 'OG000'}, {'value': '601', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000'}, {'value': '16.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.51', 'ciUpperLimit': '0.85', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Stratified by chemotherapy regimen and Follicular Lymphoma International Prognostic Index (FLIPI) risk group.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to data cut-off (up to approximately 4 years and 7 months)', 'description': 'Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or \\>/=50% increase in any node \\> 1 centimeter (cm) or \\>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \\> 1.5 cm or \\>/= 50% increase in any previously involved node with a diameter \\</= 1 cm such that it is now \\>1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).', 'unitOfMeasure': 'percentage of participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat follicular lymphoma population (FL ITT), defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '601', 'groupId': 'OG000'}, {'value': '601', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.6', 'groupId': 'OG000'}, {'value': '34.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0055', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.64', 'ciUpperLimit': '0.93', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Stratified by chemotherapy regimen and Follicular Lymphoma International Prognostic Index (FLIPI) risk group.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to final analysis (up to 10 years)', 'description': 'Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or \\>/=50% increase in any node \\> 1 centimeter (cm) or \\>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \\> 1.5 cm or \\>/= 50% increase in any previously involved node with a diameter \\</= 1 cm such that it is now \\>1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).', 'unitOfMeasure': 'percentage of participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'The FL ITT population was defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival in the Overall Study Population, Investigator-Assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'OG000'}, {'value': '702', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.5', 'groupId': 'OG000'}, {'value': '34.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0028', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.65', 'ciUpperLimit': '0.91', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to data cut-off (up to approximately 5 years and 2 months)', 'description': 'Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or \\>/=50% increase in any node \\> 1 centimeter (cm) or \\>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \\> 1.5 cm or \\>/= 50% increase in any previously involved node with a diameter \\</= 1 cm such that it is now \\>1.5 cm. Tumor measurements were obtained by CT/MRI.', 'unitOfMeasure': 'percentage of participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '601', 'groupId': 'OG000'}, {'value': '601', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000'}, {'value': '18.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0118', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.56', 'ciUpperLimit': '0.93', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to data cut-off (up to approximately 5 years and 2 months)', 'description': 'Progression-free survival in the participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or \\>/=50% increase in any node \\> 1 centimeter (cm) or \\>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \\> 1.5 cm or \\>/= 50% increase in any previously involved node with a diameter \\</= 1 cm such that it is now \\>1.5 cm. Tumor measurements were obtained by CT/MRI. In the first 170 patients with follicular lymphoma, an FDG-PET was mandatory where a PET scanner was available.', 'unitOfMeasure': 'percentage of participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'OG000'}, {'value': '702', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '18.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.57', 'ciUpperLimit': '0.90', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to data cut-off (up to approximately 5 years and 2 months)', 'description': 'Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or \\>/=50% increase in any node \\> 1 centimeter (cm) or \\>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \\> 1.5 cm or \\>/= 50% increase in any previously involved node with a diameter \\</= 1 cm such that it is now \\>1.5 cm. Tumor measurements were obtained by CT/MRI.', 'unitOfMeasure': 'percentage of participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Overall Response (Follicular Lymphoma Population), Investigator-Assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '601', 'groupId': 'OG000'}, {'value': '601', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'title': 'Without PET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'OG000'}, {'value': '530', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.4', 'groupId': 'OG000'}, {'value': '88.2', 'groupId': 'OG001'}]}]}, {'title': 'With PET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.2', 'groupId': 'OG000'}, {'value': '85.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.30', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Absolute difference in %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-2.02', 'ciUpperLimit': '5.68', 'groupDescription': 'Without PET', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Absolute difference in %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.3', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '10.5', 'groupDescription': 'With PET', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of induction period (up to approximately 7 months)', 'description': 'Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with and without PET. CR was defined as disappearance of all target lesions; PR was defined as \\>=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \\>/= 50%. Overall Response (OR) = CR + PR.', 'unitOfMeasure': 'percentage of participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Overall Response (Overall Study Population), Investigator-Assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'OG000'}, {'value': '702', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'title': 'Without PET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '599', 'groupId': 'OG000'}, {'value': '613', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000'}, {'value': '87.3', 'groupId': 'OG001'}]}]}, {'title': 'With PET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000'}, {'value': '85.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Absolute difference in %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '5.3', 'groupDescription': 'Without PET', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Absolute difference in %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.5', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '9.4', 'groupDescription': 'With PET', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of induction period (up to approximately 7 months)', 'description': 'Overall response in the overall study population was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without positron emission tomography (PET). CR was defined as disappearance of all target lesions; PR was defined as \\>=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \\>/= 50%; Overall Response (OR) = CR + PR.', 'unitOfMeasure': 'percentage of participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Complete Response (Follicular Lymphoma Population), Investigator-Assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '601', 'groupId': 'OG000'}, {'value': '601', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'title': 'Without PET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000'}, {'value': '18.6', 'groupId': 'OG001'}]}]}, {'title': 'With PET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.7', 'groupId': 'OG000'}, {'value': '62.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Absolute difference in %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.5', 'ciLowerLimit': '-10.2', 'ciUpperLimit': '-0.78', 'groupDescription': 'Without PET', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.32', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Absolute difference in %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.2', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '13.3', 'groupDescription': 'With PET', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of induction period (up to approximately 7 months)', 'description': 'Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.', 'unitOfMeasure': 'percentage of participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Complete Response (Overall Study Population), Investigator-Assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'OG000'}, {'value': '702', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'title': 'Without PET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.3', 'groupId': 'OG000'}, {'value': '18.4', 'groupId': 'OG001'}]}]}, {'title': 'With PET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.0', 'groupId': 'OG000'}, {'value': '61.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Absolute difference in %', 'ciPctValue': '95', 'paramValue': '-4.9', 'ciLowerLimit': '-9.3', 'ciUpperLimit': '0.6', 'groupDescription': 'Without PET', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Absolute difference in %', 'ciPctValue': '95', 'paramValue': '4.1', 'ciLowerLimit': '-3.6', 'ciUpperLimit': '11.8', 'groupDescription': 'With PET', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of induction period (up to approximately 7 months)', 'description': 'Percentage of participants with complete response in the overall study population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.', 'unitOfMeasure': 'percentage of participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Overall Response (Follicular Lymphoma Population), IRC-Assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '601', 'groupId': 'OG000'}, {'value': '601', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'title': 'Without PET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '529', 'groupId': 'OG000'}, {'value': '549', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000'}, {'value': '91.3', 'groupId': 'OG001'}]}]}, {'title': 'With PET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.2', 'groupId': 'OG000'}, {'value': '88.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.052', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Absolute difference in %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.3', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '6.85', 'groupDescription': 'Without PET', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.30', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Absolute difference in %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.3', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '8.9', 'groupDescription': 'With PET', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of induction period (up to approximately 7 months)', 'description': 'Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as \\>=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \\>/= 50%. Overall Response (OR) = CR + PR.', 'unitOfMeasure': 'percentage of participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Overall Response (Overall Study Population), IRC-Assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'OG000'}, {'value': '702', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'title': 'Without PET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '631', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000'}, {'value': '89.9', 'groupId': 'OG001'}]}]}, {'title': 'With PET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000'}, {'value': '87.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.049', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Absolute difference in %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.2', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '6.6', 'groupDescription': 'Without PET', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Absolute difference in %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.9', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '9.5', 'groupDescription': 'With PET', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of induction period (up to approximately 7 months)', 'description': 'Overall response in the overall study population was defined as percentage of participants with PR or CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as \\>=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \\>/= 50%; Overall Response (OR) = CR + PR.', 'unitOfMeasure': 'percentage of participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Complete Response (Follicular Lymphoma Population), IRC-Assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '601', 'groupId': 'OG000'}, {'value': '601', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'title': 'Without PET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.8', 'groupId': 'OG000'}, {'value': '28.5', 'groupId': 'OG001'}]}]}, {'title': 'With PET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.7', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Absolute difference in %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '-3.5', 'ciUpperLimit': '6.8', 'groupDescription': 'Without PET', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Absolute difference in %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.7', 'ciLowerLimit': '3.9', 'ciUpperLimit': '19.4', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of induction period (up to approximately 7 months)', 'description': 'Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.', 'unitOfMeasure': 'percentage of participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Complete Response (Overall Study Population), IRC-Assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'OG000'}, {'value': '702', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'title': 'Without PET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.3', 'groupId': 'OG000'}, {'value': '27.1', 'groupId': 'OG001'}]}]}, {'title': 'With PET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.4', 'groupId': 'OG000'}, {'value': '69.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.80', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Absolute difference in %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '5.5', 'groupDescription': 'Without PET', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Absolute difference in %', 'ciPctValue': '95', 'paramValue': '10.1', 'ciLowerLimit': '2.6', 'ciUpperLimit': '17.6', 'groupDescription': 'With PET', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of induction period (up to approximately 7 months)]', 'description': 'Percentage of participants with complete response in the overall study population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.', 'unitOfMeasure': 'percentage of participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (Follicular Lymphoma Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '601', 'groupId': 'OG000'}, {'value': '601', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '12.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3577', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.63', 'ciUpperLimit': '1.18', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 10 years', 'description': 'Overall survival in the follicular lymphoma population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event.', 'unitOfMeasure': 'percentage of participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (Overall Study Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'OG000'}, {'value': '702', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}, {'value': '8.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.58', 'ciUpperLimit': '1.16', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to data cut-off (up to approximately 5 years and 2 months)', 'description': 'Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event.', 'unitOfMeasure': 'percentage of participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Event-Free Survival (Follicular Lymphoma Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '601', 'groupId': 'OG000'}, {'value': '601', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000'}, {'value': '35.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.62', 'ciUpperLimit': '0.89', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 10 years', 'description': 'Event-free survival in the follicular lymphoma population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or \\>/=50% increase in any node \\> 1 centimeter (cm) or \\>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \\> 1.5 cm or \\>/= 50% increase in any previously involved node with a diameter \\</= 1 cm such that it is now \\>1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with an event.', 'unitOfMeasure': 'percentage of participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Event-Free Survival (Overall Study Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'OG000'}, {'value': '702', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.6', 'groupId': 'OG000'}, {'value': '22.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.56', 'ciUpperLimit': '0.85', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to data cut-off (up to approximately 5 years and 2 months)', 'description': 'Event-free survival in the overall study population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or \\>/=50% increase in any node \\> 1 centimeter (cm) or \\>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \\> 1.5 cm or \\>/= 50% increase in any previously involved node with a diameter \\</= 1 cm such that it is now \\>1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with event.', 'unitOfMeasure': 'percentage of participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Disease-Free Survival (Follicular Lymphoma Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.9', 'groupId': 'OG000'}, {'value': '26.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.27', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)', 'description': 'Disease-free survival in the follicular lymphoma population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma (RRCML). Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or \\>/=50% increase in any node \\> 1 centimeter (cm) or \\>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \\> 1.5 cm or \\>/= 50% increase in any previously involved node with a diameter \\</= 1 cm such that it is now \\>1.5 cm. Reported is the percentage of participants with event.', 'unitOfMeasure': 'percentage of participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with CR within the FL ITT population were included in the analysis.The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Disease-Free Survival (Overall Study Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}, {'value': '11.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.50', 'ciUpperLimit': '1.19', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)', 'description': 'Disease-free survival in the overall study population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or \\>/=50% increase in any node \\> 1 centimeter (cm) or \\>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \\> 1.5 cm or \\>/= 50% increase in any previously involved node with a diameter \\</= 1 cm such that it is now \\>1.5 cm. Reported is the percentage of participants with event.', 'unitOfMeasure': 'percentage of participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with CR within the ITT population were included in the analysis.The ITT population was defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '568', 'groupId': 'OG000'}, {'value': '571', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.63', 'ciUpperLimit': '0.93', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From first occurrence of documented CR or PR to data cut-off (up to approximately 5 years and 2 months)', 'description': 'DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as \\>/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \\>/= 50%. Progression/relapse was defined as at least 50% increase in nodal lesions or \\>/=50% increase in any node \\> 1 centimeter (cm) or \\>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \\> 1.5 cm or \\>/= 50% increase in any previously involved node with a diameter \\</= 1 cm such that it is now \\>1.5 cm.', 'unitOfMeasure': 'percentage of participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with CR or PR within the FL ITT population were included in the analysis.The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) (Overall Study Population), Investigator-Assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '656', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.5', 'groupId': 'OG000'}, {'value': '18.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.55', 'ciUpperLimit': '0.88', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months)', 'description': 'DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as \\>/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \\>/= 50%. Progression/relapse was defined as at least 50% increase in nodal lesions or \\>/=50% increase in any node \\> 1 centimeter (cm) or \\>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \\> 1.5 cm or \\>/= 50% increase in any previously involved node with a diameter \\</= 1 cm such that it is now \\>1.5 cm.', 'unitOfMeasure': 'percentage of participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with CR or PR within the ITT population were included in the analysis. The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '601', 'groupId': 'OG000'}, {'value': '601', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.8', 'groupId': 'OG000'}, {'value': '26.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.58', 'ciUpperLimit': '0.87', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 10 years', 'description': 'Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. Reported is the percentage of participants with event.', 'unitOfMeasure': 'percentage of participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Time to Next Anti-Lymphoma Treatment (Overall Study Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'OG000'}, {'value': '702', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.6', 'groupId': 'OG000'}, {'value': '15.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.54', 'ciUpperLimit': '0.89', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to data cut-off (up to approximately 5 years and 2 months)', 'description': 'Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. Reported is the percentage of participants with event.', 'unitOfMeasure': 'percentage of participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '692', 'groupId': 'OG000'}, {'value': '698', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000'}, {'value': '99.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 10 years', 'description': 'An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population included all participants who received any amount of any study drug and participants were analyzed according to the treatment received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '557', 'groupId': 'OG000'}, {'value': '566', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.'}], 'classes': [{'title': 'Physical Well-being (PW), Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '557', 'groupId': 'OG000'}, {'value': '566', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.36', 'spread': '4.77', 'groupId': 'OG000'}, {'value': '23.14', 'spread': '4.85', 'groupId': 'OG001'}]}]}, {'title': 'PW Change, Cycle 3, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.91', 'spread': '4.54', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '4.59', 'groupId': 'OG001'}]}]}, {'title': 'PW Change, End Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '4.83', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '5.14', 'groupId': 'OG001'}]}]}, {'title': 'PW Change, Maint Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.83', 'spread': '4.76', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '5.09', 'groupId': 'OG001'}]}]}, {'title': 'PW Change, Maint Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.14', 'spread': '4.29', 'groupId': 'OG000'}, {'value': '1.34', 'spread': '4.74', 'groupId': 'OG001'}]}]}, {'title': 'PW Change, End Maint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.88', 'spread': '4.54', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '5.00', 'groupId': 'OG001'}]}]}, {'title': 'Social/Family Well-being , Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '555', 'groupId': 'OG000'}, {'value': '563', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.84', 'spread': '4.92', 'groupId': 'OG000'}, {'value': '23.28', 'spread': '4.77', 'groupId': 'OG001'}]}]}, {'title': 'S/FW Change, Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '492', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.52', 'spread': '4.03', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '3.92', 'groupId': 'OG001'}]}]}, {'title': 'S/FW Change, End Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.46', 'spread': '4.77', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '5.00', 'groupId': 'OG001'}]}]}, {'title': 'S/FW Change, Maint Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.39', 'spread': '4.72', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '4.68', 'groupId': 'OG001'}]}]}, {'title': 'S/FW Change, Maint Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.61', 'spread': '5.56', 'groupId': 'OG000'}, {'value': '-0.97', 'spread': '5.34', 'groupId': 'OG001'}]}]}, {'title': 'S/FW Change, End Maint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.93', 'spread': '5.67', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '5.54', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Well-being (EW), Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '556', 'groupId': 'OG000'}, {'value': '563', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.64', 'spread': '4.19', 'groupId': 'OG000'}, {'value': '17.87', 'spread': '4.13', 'groupId': 'OG001'}]}]}, {'title': 'EW Change, Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '490', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.49', 'spread': '3.40', 'groupId': 'OG000'}, {'value': '1.35', 'spread': '3.35', 'groupId': 'OG001'}]}]}, {'title': 'EW Change, End Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}, {'value': '476', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.16', 'spread': '3.90', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '3.87', 'groupId': 'OG001'}]}]}, {'title': 'EW Change, Maint Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.77', 'spread': '3.88', 'groupId': 'OG000'}, {'value': '1.49', 'spread': '4.16', 'groupId': 'OG001'}]}]}, {'title': 'EW Change, Maint Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.45', 'spread': '3.92', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '3.88', 'groupId': 'OG001'}]}]}, {'title': 'EW Change, End Maint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '405', 'groupId': 'OG000'}, {'value': '435', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.43', 'spread': '3.98', 'groupId': 'OG000'}, {'value': '1.49', 'spread': '3.99', 'groupId': 'OG001'}]}]}, {'title': 'Functional Well-being (FW), Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '556', 'groupId': 'OG000'}, {'value': '563', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.66', 'spread': '6.19', 'groupId': 'OG000'}, {'value': '18.76', 'spread': '5.98', 'groupId': 'OG001'}]}]}, {'title': 'FW Change, Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '504', 'groupId': 'OG000'}, {'value': '488', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.30', 'spread': '5.30', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '5.24', 'groupId': 'OG001'}]}]}, {'title': 'FW Change, End Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '476', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.44', 'spread': '5.63', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '5.85', 'groupId': 'OG001'}]}]}, {'title': 'FW Change, Maint Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.04', 'spread': '5.31', 'groupId': 'OG000'}, {'value': '1.25', 'spread': '6.02', 'groupId': 'OG001'}]}]}, {'title': 'FW Change, Maint Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.84', 'spread': '5.54', 'groupId': 'OG000'}, {'value': '1.65', 'spread': '5.95', 'groupId': 'OG001'}]}]}, {'title': 'FW Change, End Maint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.40', 'spread': '6.12', 'groupId': 'OG000'}, {'value': '1.72', 'spread': '6.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)', 'description': 'FACT-G consists of the following 4 FACT-Lym sub-questionnaires: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24) and Functional Well-being (range: 0-28). Higher scores indicate better outcomes. A positive change from baseline indicates improvement. Maint = Maintenance period.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'OG000'}, {'value': '567', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.'}], 'classes': [{'title': 'TOI Score, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'OG000'}, {'value': '567', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.61', 'spread': '18.16', 'groupId': 'OG000'}, {'value': '86.94', 'spread': '18.05', 'groupId': 'OG001'}]}]}, {'title': 'TOI Score Change, Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'OG000'}, {'value': '497', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.46', 'spread': '15.03', 'groupId': 'OG000'}, {'value': '2.18', 'spread': '15.95', 'groupId': 'OG001'}]}]}, {'title': 'TOI Score Change, End Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'OG000'}, {'value': '481', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.91', 'spread': '17.00', 'groupId': 'OG000'}, {'value': '4.57', 'spread': '16.71', 'groupId': 'OG001'}]}]}, {'title': 'TOI Score Change, Maint M2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}, {'value': '400', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.22', 'spread': '16.16', 'groupId': 'OG000'}, {'value': '7.17', 'spread': '16.57', 'groupId': 'OG001'}]}]}, {'title': 'TOI Score Change, Maint M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '408', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.61', 'spread': '15.62', 'groupId': 'OG000'}, {'value': '7.20', 'spread': '16.75', 'groupId': 'OG001'}]}]}, {'title': 'TOI Score Change, End Maint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '440', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.23', 'spread': '17.06', 'groupId': 'OG000'}, {'value': '7.44', 'spread': '16.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)', 'description': 'The FACT-Lym TOI Score for the follicular lymphoma population was derived from the following 3 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym TOI Score is the sum of the 3 individual subscales (range 0-116). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '556', 'groupId': 'OG000'}, {'value': '563', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.'}], 'classes': [{'title': 'Lymphoma, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '556', 'groupId': 'OG000'}, {'value': '563', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.01', 'spread': '9.37', 'groupId': 'OG000'}, {'value': '45.54', 'spread': '9.29', 'groupId': 'OG001'}]}]}, {'title': 'Lymphoma Change, Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '509', 'groupId': 'OG000'}, {'value': '491', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.04', 'spread': '7.18', 'groupId': 'OG000'}, {'value': '2.71', 'spread': '7.46', 'groupId': 'OG001'}]}]}, {'title': 'Lymphoma Change, End Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '477', 'groupId': 'OG000'}, {'value': '478', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.99', 'spread': '8.63', 'groupId': 'OG000'}, {'value': '3.01', 'spread': '8.36', 'groupId': 'OG001'}]}]}, {'title': 'Lymphoma Change, Maint Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '395', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.80', 'spread': '8.29', 'groupId': 'OG000'}, {'value': '4.52', 'spread': '8.32', 'groupId': 'OG001'}]}]}, {'title': 'Lymphoma Change, Maint Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.93', 'spread': '8.34', 'groupId': 'OG000'}, {'value': '4.27', 'spread': '8.31', 'groupId': 'OG001'}]}]}, {'title': 'Lymphoma Change, End Maint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '407', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.31', 'spread': '8.81', 'groupId': 'OG000'}, {'value': '4.57', 'spread': '8.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)', 'description': 'The FACT-Lym Individual Subscale Lymphoma Score for the follicular lymphoma population was derived from the Lymphoma subscale questionnaire (range: 0-60). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '552', 'groupId': 'OG000'}, {'value': '559', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.'}], 'classes': [{'title': 'Total Score, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '552', 'groupId': 'OG000'}, {'value': '559', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '127.40', 'spread': '22.43', 'groupId': 'OG000'}, {'value': '128.42', 'spread': '22.16', 'groupId': 'OG001'}]}]}, {'title': 'Total Score Change, Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '499', 'groupId': 'OG000'}, {'value': '484', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.98', 'spread': '17.01', 'groupId': 'OG000'}, {'value': '3.21', 'spread': '17.12', 'groupId': 'OG001'}]}]}, {'title': 'Total Score Change, End Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '471', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.18', 'spread': '19.75', 'groupId': 'OG000'}, {'value': '5.10', 'spread': '20.03', 'groupId': 'OG001'}]}]}, {'title': 'Total Score Change, Maint Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.40', 'spread': '19.16', 'groupId': 'OG000'}, {'value': '8.13', 'spread': '19.80', 'groupId': 'OG001'}]}]}, {'title': 'Total Score Change, Maint Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.87', 'spread': '19.31', 'groupId': 'OG000'}, {'value': '7.90', 'spread': '19.55', 'groupId': 'OG001'}]}]}, {'title': 'Total Score Change, End Maint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '401', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.43', 'spread': '19.88', 'groupId': 'OG000'}, {'value': '8.80', 'spread': '20.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)', 'description': 'The FACT-Lym Total Score for the follicular lymphoma population was derived from the following 5 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24),Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym Total Score is the sum of all 5 individual subscales (range 0-168). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '558', 'groupId': 'OG000'}, {'value': '559', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'title': 'Baseline Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '558', 'groupId': 'OG000'}, {'value': '559', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.80', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline, Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline, Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '505', 'groupId': 'OG000'}, {'value': '487', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline, Induction Compl', 'denoms': [{'units': 'Participants', 'counts': [{'value': '468', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline, Maint/Obs Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline, Maint/Obs Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': 'NA', 'comment': 'NA = NE = Not estimable based on 1 participant evaluated', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline, Maint/Obs Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'spread': 'NA', 'comment': 'NA = NE = Not estimable based on 1 participant evaluated', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months)', 'description': 'The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Completion (Compl) includes completion visit and early termination visit. Maintenance/Observation is indicated as Maint/Obs.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '536', 'groupId': 'OG000'}, {'value': '547', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'title': 'Change Baseline, Maint/Obs Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline, Maint/Obs Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '536', 'groupId': 'OG000'}, {'value': '547', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline, Maint/Obs Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '402', 'groupId': 'OG000'}, {'value': '421', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months)', 'description': 'The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1 Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs. Completion includes completion visit and early termination visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '563', 'groupId': 'OG000'}, {'value': '564', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}, {'id': 'OG001', 'title': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.'}], 'classes': [{'title': 'Change Baseline, Follow-Up Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline, Follow-Up Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 after Day 1 of last induction cycle, Follow-up: every year for up to data cut-off (up to 5 years and 2 months)', 'description': 'The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs in data categories. Completion includes completion visit and early termination visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rituximab+Chemotherapy - Induction Period', 'description': 'Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.'}, {'id': 'FG001', 'title': 'Obinutuzumab+Chemotherapy - Induction Period', 'description': 'Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.'}, {'id': 'FG002', 'title': 'Rituximab+Chemotherapy - Maintenance Period', 'description': 'The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period.'}, {'id': 'FG003', 'title': 'Obinutuzumab+Chemotherapy - Maintenance Period', 'description': 'The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period.'}, {'id': 'FG004', 'title': 'Rituximab+Chemotherapy - Observation Period', 'description': 'Rituximab+Chemotherapy - Observation: The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Non-responders received no protocol specified treatment during the 2-year observation period.'}, {'id': 'FG005', 'title': 'Obinutuzumab+Chemotherapy - Observation Period', 'description': 'Obinutuzumab+Chemotherapy - Observation: The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Non-responders received no protocol specified treatment during the 2-year observation period.'}, {'id': 'FG006', 'title': 'Rituximab+Chemotherapy - Follow-Up Period', 'description': 'Finally, participants were followed during a 5-year follow-up period.'}, {'id': 'FG007', 'title': 'Obinutuzumab+Chemotherapy - Follow-Up Period', 'description': 'Finally, participants were followed during a 5-year follow-up period.'}], 'periods': [{'title': 'Induction Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '699'}, {'groupId': 'FG001', 'numSubjects': '702'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '641'}, {'groupId': 'FG001', 'numSubjects': '646'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Randomised but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Maintenance/Observation Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '612'}, {'groupId': 'FG003', 'numSubjects': '624'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '451'}, {'groupId': 'FG003', 'numSubjects': '475'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '161'}, {'groupId': 'FG003', 'numSubjects': '149'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '53'}, {'groupId': 'FG003', 'numSubjects': '66'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '72'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Follow-Up Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '554'}, {'groupId': 'FG007', 'numSubjects': '602'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '324'}, {'groupId': 'FG007', 'numSubjects': '367'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '230'}, {'groupId': 'FG007', 'numSubjects': '235'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '27'}, {'groupId': 'FG007', 'numSubjects': '30'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '11'}, {'groupId': 'FG007', 'numSubjects': '15'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '9'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '18'}, {'groupId': 'FG007', 'numSubjects': '21'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '12'}, {'groupId': 'FG007', 'numSubjects': '15'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '126'}, {'groupId': 'FG007', 'numSubjects': '106'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '29'}, {'groupId': 'FG007', 'numSubjects': '32'}]}, {'type': 'No reason provided', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'The study was conducted at 177 centers in 18 countries.', 'preAssignmentDetails': 'Eleven participants withdrew from the study after randomization but prior to receiving study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'BG000'}, {'value': '702', 'groupId': 'BG001'}, {'value': '1401', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rituximab+Chemotherapy - Induction Period', 'description': 'Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.'}, {'id': 'BG001', 'title': 'Obinutuzumab+Chemotherapy - Induction Period', 'description': 'Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'BG000'}, {'value': '702', 'groupId': 'BG001'}, {'value': '1401', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58.1', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '58.9', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '58.5', 'spread': '11.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'BG000'}, {'value': '702', 'groupId': 'BG001'}, {'value': '1401', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '374', 'groupId': 'BG000'}, {'value': '365', 'groupId': 'BG001'}, {'value': '739', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '325', 'groupId': 'BG000'}, {'value': '337', 'groupId': 'BG001'}, {'value': '662', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous in Follicular Lymphoma Sub-Population', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'BG000'}, {'value': '702', 'groupId': 'BG001'}, {'value': '1401', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '57.7', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '58.2', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '57.9', 'spread': '11.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Age continuous for participants with follicular lymphoma (FL) in each arm, who encompassed the population for the primary outcome measure. The FL ITT included participants in the ITT population with follicular histology (n=601 in each arm).', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender in Follicular Lymphoma Sub-Population', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '601', 'groupId': 'BG000'}, {'value': '601', 'groupId': 'BG001'}, {'value': '1202', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '321', 'groupId': 'BG000'}, {'value': '318', 'groupId': 'BG001'}, {'value': '639', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '280', 'groupId': 'BG000'}, {'value': '283', 'groupId': 'BG001'}, {'value': '563', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Gender of participants with follicular lymphoma, who encompassed the population for the primary outcome measure. The FL ITT included participants in the ITT population with follicular histology (n=601 for each arm).', 'unitOfMeasure': 'Participants', 'populationDescription': 'As this is a sub-population, the numbers analyzed differ from the overall population numbers as not all are included here.'}], 'populationDescription': 'The intent-to treat (ITT) population was defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-15', 'size': 1978016, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-07-06T11:48', 'hasProtocol': True}, {'date': '2016-04-12', 'size': 1681818, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-07-06T11:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1401}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-09', 'studyFirstSubmitDate': '2011-04-08', 'resultsFirstSubmitDate': '2017-02-03', 'studyFirstSubmitQcDate': '2011-04-08', 'lastUpdatePostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-05', 'studyFirstPostDateStruct': {'date': '2011-04-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed', 'timeFrame': 'Baseline up to data cut-off (up to approximately 4 years and 7 months)', 'description': 'Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or \\>/=50% increase in any node \\> 1 centimeter (cm) or \\>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \\> 1.5 cm or \\>/= 50% increase in any previously involved node with a diameter \\</= 1 cm such that it is now \\>1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed', 'timeFrame': 'Baseline up to final analysis (up to 10 years)', 'description': 'Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or \\>/=50% increase in any node \\> 1 centimeter (cm) or \\>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \\> 1.5 cm or \\>/= 50% increase in any previously involved node with a diameter \\</= 1 cm such that it is now \\>1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).'}, {'measure': 'Progression-Free Survival in the Overall Study Population, Investigator-Assessed', 'timeFrame': 'Baseline up to data cut-off (up to approximately 5 years and 2 months)', 'description': 'Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or \\>/=50% increase in any node \\> 1 centimeter (cm) or \\>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \\> 1.5 cm or \\>/= 50% increase in any previously involved node with a diameter \\</= 1 cm such that it is now \\>1.5 cm. Tumor measurements were obtained by CT/MRI.'}, {'measure': 'Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed', 'timeFrame': 'Baseline up to data cut-off (up to approximately 5 years and 2 months)', 'description': 'Progression-free survival in the participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or \\>/=50% increase in any node \\> 1 centimeter (cm) or \\>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \\> 1.5 cm or \\>/= 50% increase in any previously involved node with a diameter \\</= 1 cm such that it is now \\>1.5 cm. Tumor measurements were obtained by CT/MRI. In the first 170 patients with follicular lymphoma, an FDG-PET was mandatory where a PET scanner was available.'}, {'measure': 'Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC)', 'timeFrame': 'Baseline up to data cut-off (up to approximately 5 years and 2 months)', 'description': 'Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or \\>/=50% increase in any node \\> 1 centimeter (cm) or \\>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \\> 1.5 cm or \\>/= 50% increase in any previously involved node with a diameter \\</= 1 cm such that it is now \\>1.5 cm. Tumor measurements were obtained by CT/MRI.'}, {'measure': 'Overall Response (Follicular Lymphoma Population), Investigator-Assessed', 'timeFrame': 'Baseline up to end of induction period (up to approximately 7 months)', 'description': 'Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with and without PET. CR was defined as disappearance of all target lesions; PR was defined as \\>=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \\>/= 50%. Overall Response (OR) = CR + PR.'}, {'measure': 'Overall Response (Overall Study Population), Investigator-Assessed', 'timeFrame': 'Baseline up to end of induction period (up to approximately 7 months)', 'description': 'Overall response in the overall study population was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without positron emission tomography (PET). CR was defined as disappearance of all target lesions; PR was defined as \\>=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \\>/= 50%; Overall Response (OR) = CR + PR.'}, {'measure': 'Complete Response (Follicular Lymphoma Population), Investigator-Assessed', 'timeFrame': 'Baseline up to end of induction period (up to approximately 7 months)', 'description': 'Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.'}, {'measure': 'Complete Response (Overall Study Population), Investigator-Assessed', 'timeFrame': 'Baseline up to end of induction period (up to approximately 7 months)', 'description': 'Percentage of participants with complete response in the overall study population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.'}, {'measure': 'Overall Response (Follicular Lymphoma Population), IRC-Assessed', 'timeFrame': 'Baseline up to end of induction period (up to approximately 7 months)', 'description': 'Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as \\>=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \\>/= 50%. Overall Response (OR) = CR + PR.'}, {'measure': 'Overall Response (Overall Study Population), IRC-Assessed', 'timeFrame': 'Baseline up to end of induction period (up to approximately 7 months)', 'description': 'Overall response in the overall study population was defined as percentage of participants with PR or CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as \\>=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \\>/= 50%; Overall Response (OR) = CR + PR.'}, {'measure': 'Complete Response (Follicular Lymphoma Population), IRC-Assessed', 'timeFrame': 'Baseline up to end of induction period (up to approximately 7 months)', 'description': 'Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.'}, {'measure': 'Complete Response (Overall Study Population), IRC-Assessed', 'timeFrame': 'Baseline up to end of induction period (up to approximately 7 months)]', 'description': 'Percentage of participants with complete response in the overall study population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.'}, {'measure': 'Overall Survival (Follicular Lymphoma Population)', 'timeFrame': 'Baseline up to 10 years', 'description': 'Overall survival in the follicular lymphoma population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event.'}, {'measure': 'Overall Survival (Overall Study Population)', 'timeFrame': 'Baseline up to data cut-off (up to approximately 5 years and 2 months)', 'description': 'Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event.'}, {'measure': 'Event-Free Survival (Follicular Lymphoma Population)', 'timeFrame': 'Baseline up to 10 years', 'description': 'Event-free survival in the follicular lymphoma population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or \\>/=50% increase in any node \\> 1 centimeter (cm) or \\>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \\> 1.5 cm or \\>/= 50% increase in any previously involved node with a diameter \\</= 1 cm such that it is now \\>1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with an event.'}, {'measure': 'Event-Free Survival (Overall Study Population)', 'timeFrame': 'Baseline up to data cut-off (up to approximately 5 years and 2 months)', 'description': 'Event-free survival in the overall study population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or \\>/=50% increase in any node \\> 1 centimeter (cm) or \\>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \\> 1.5 cm or \\>/= 50% increase in any previously involved node with a diameter \\</= 1 cm such that it is now \\>1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with event.'}, {'measure': 'Disease-Free Survival (Follicular Lymphoma Population)', 'timeFrame': 'From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)', 'description': 'Disease-free survival in the follicular lymphoma population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma (RRCML). Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or \\>/=50% increase in any node \\> 1 centimeter (cm) or \\>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \\> 1.5 cm or \\>/= 50% increase in any previously involved node with a diameter \\</= 1 cm such that it is now \\>1.5 cm. Reported is the percentage of participants with event.'}, {'measure': 'Disease-Free Survival (Overall Study Population)', 'timeFrame': 'From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)', 'description': 'Disease-free survival in the overall study population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or \\>/=50% increase in any node \\> 1 centimeter (cm) or \\>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \\> 1.5 cm or \\>/= 50% increase in any previously involved node with a diameter \\</= 1 cm such that it is now \\>1.5 cm. Reported is the percentage of participants with event.'}, {'measure': 'Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed', 'timeFrame': 'From first occurrence of documented CR or PR to data cut-off (up to approximately 5 years and 2 months)', 'description': 'DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as \\>/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \\>/= 50%. Progression/relapse was defined as at least 50% increase in nodal lesions or \\>/=50% increase in any node \\> 1 centimeter (cm) or \\>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \\> 1.5 cm or \\>/= 50% increase in any previously involved node with a diameter \\</= 1 cm such that it is now \\>1.5 cm.'}, {'measure': 'Duration of Response (DOR) (Overall Study Population), Investigator-Assessed', 'timeFrame': 'From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months)', 'description': 'DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as \\>/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \\>/= 50%. Progression/relapse was defined as at least 50% increase in nodal lesions or \\>/=50% increase in any node \\> 1 centimeter (cm) or \\>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \\> 1.5 cm or \\>/= 50% increase in any previously involved node with a diameter \\</= 1 cm such that it is now \\>1.5 cm.'}, {'measure': 'Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population)', 'timeFrame': 'Baseline up to 10 years', 'description': 'Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. Reported is the percentage of participants with event.'}, {'measure': 'Time to Next Anti-Lymphoma Treatment (Overall Study Population)', 'timeFrame': 'Baseline up to data cut-off (up to approximately 5 years and 2 months)', 'description': 'Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. Reported is the percentage of participants with event.'}, {'measure': 'Percentage of Participants With Adverse Events', 'timeFrame': 'Baseline up to 10 years', 'description': 'An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.'}, {'measure': 'Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population)', 'timeFrame': 'Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)', 'description': 'FACT-G consists of the following 4 FACT-Lym sub-questionnaires: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24) and Functional Well-being (range: 0-28). Higher scores indicate better outcomes. A positive change from baseline indicates improvement. Maint = Maintenance period.'}, {'measure': 'Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population)', 'timeFrame': 'Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)', 'description': 'The FACT-Lym TOI Score for the follicular lymphoma population was derived from the following 3 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym TOI Score is the sum of the 3 individual subscales (range 0-116). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.'}, {'measure': 'Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population)', 'timeFrame': 'Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)', 'description': 'The FACT-Lym Individual Subscale Lymphoma Score for the follicular lymphoma population was derived from the Lymphoma subscale questionnaire (range: 0-60). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.'}, {'measure': 'Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population)', 'timeFrame': 'Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)', 'description': 'The FACT-Lym Total Score for the follicular lymphoma population was derived from the following 5 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24),Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym Total Score is the sum of all 5 individual subscales (range 0-168). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.'}, {'measure': 'Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase', 'timeFrame': 'Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months)', 'description': 'The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Completion (Compl) includes completion visit and early termination visit. Maintenance/Observation is indicated as Maint/Obs.'}, {'measure': 'Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase', 'timeFrame': 'Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months)', 'description': 'The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1 Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs. Completion includes completion visit and early termination visit.'}, {'measure': 'Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase', 'timeFrame': 'Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 after Day 1 of last induction cycle, Follow-up: every year for up to data cut-off (up to 5 years and 2 months)', 'description': 'The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs in data categories. Completion includes completion visit and early termination visit.'}]}, 'conditionsModule': {'conditions': ["Non-Hodgkin's Lymphoma"]}, 'referencesModule': {'references': [{'pmid': '38096461', 'type': 'DERIVED', 'citation': 'Pott C, Jurinovic V, Trotman J, Kehden B, Unterhalt M, Herold M, Jagt RV, Janssens A, Kneba M, Mayer J, Young M, Schmidt C, Knapp A, Nielsen T, Brown H, Spielewoy N, Harbron C, Bottos A, Mundt K, Marcus R, Hiddemann W, Hoster E. Minimal Residual Disease Status Predicts Outcome in Patients With Previously Untreated Follicular Lymphoma: A Prospective Analysis of the Phase III GALLIUM Study. J Clin Oncol. 2024 Feb 10;42(5):550-561. doi: 10.1200/JCO.23.00838. Epub 2023 Dec 14.'}, {'pmid': '36379880', 'type': 'DERIVED', 'citation': 'Casulo C, Herold M, Hiddemann W, Iyengar S, Marcus RE, Seymour JF, Launonen A, Knapp A, Nielsen TG, Mir F. Risk Factors for and Outcomes of Follicular Lymphoma Histological Transformation at First Progression in the GALLIUM Study. Clin Lymphoma Myeloma Leuk. 2023 Jan;23(1):40-48. doi: 10.1016/j.clml.2022.09.003. Epub 2022 Oct 4.'}, {'pmid': '35194005', 'type': 'DERIVED', 'citation': 'Hong X, Song Y, Shi Y, Zhang Q, Guo W, Wu G, Li J, Feng J, Kinkolykh A, Knapp A, Lin T. Efficacy and safety of obinutuzumab for the first-line treatment of follicular lymphoma: a subgroup analysis of Chinese patients enrolled in the phase III GALLIUM study. Chin Med J (Engl). 2021 Sep 16;135(4):433-440. doi: 10.1097/CM9.0000000000001737.'}, {'pmid': '34323957', 'type': 'DERIVED', 'citation': 'Strefford JC, Nowicka M, Hargreaves CE, Burton C, Davies A, Ganderton R, Hiddemann W, Iriyama C, Klapper W, Latham KV, Martelli M, Mir F, Parker H, Potter KN, Rose-Zerilli MJJ, Sehn LH, Trneny M, Vitolo U, Bolen CR, Klein C, Knapp A, Oestergaard MZ, Cragg MS. Single-nucleotide Fcgamma receptor polymorphisms do not impact obinutuzumab/rituximab outcome in patients with lymphoma. Blood Adv. 2021 Aug 10;5(15):2935-2944. doi: 10.1182/bloodadvances.2020003985.'}, {'pmid': '32314038', 'type': 'DERIVED', 'citation': 'Davies A, Trask P, Demeter J, Florschutz A, Hanel M, Kinoshita T, Pettengell R, Quach H, Robinson S, Sadullah S, Sancho JM, Udvardy M, Witzens-Harig M, Knapp A, Liu W. Health-related quality of life in the phase III GALLIUM study of obinutuzumab- or rituximab-based chemotherapy in patients with previously untreated advanced follicular lymphoma. Ann Hematol. 2020 Dec;99(12):2837-2846. doi: 10.1007/s00277-020-04021-6. Epub 2020 Apr 20.'}, {'pmid': '31053601', 'type': 'DERIVED', 'citation': 'Klanova M, Oestergaard MZ, Trneny M, Hiddemann W, Marcus R, Sehn LH, Vitolo U, Bazeos A, Goede V, Zeuner H, Knapp A, Sahin D, Spielewoy N, Bolen CR, Cardona A, Klein C, Venstrom JM, Nielsen T, Fingerle-Rowson G. Prognostic Impact of Natural Killer Cell Count in Follicular Lymphoma and Diffuse Large B-cell Lymphoma Patients Treated with Immunochemotherapy. Clin Cancer Res. 2019 Aug 1;25(15):4634-4643. doi: 10.1158/1078-0432.CCR-18-3270. Epub 2019 May 3.'}, {'pmid': '30341058', 'type': 'DERIVED', 'citation': 'Kusumoto S, Arcaini L, Hong X, Jin J, Kim WS, Kwong YL, Peters MG, Tanaka Y, Zelenetz AD, Kuriki H, Fingerle-Rowson G, Nielsen T, Ueda E, Piper-Lepoutre H, Sellam G, Tobinai K. Risk of HBV reactivation in patients with B-cell lymphomas receiving obinutuzumab or rituximab immunochemotherapy. Blood. 2019 Jan 10;133(2):137-146. doi: 10.1182/blood-2018-04-848044. Epub 2018 Oct 19.'}, {'pmid': '30309758', 'type': 'DERIVED', 'citation': 'Trotman J, Barrington SF, Belada D, Meignan M, MacEwan R, Owen C, Ptacnik V, Rosta A, Fingerle-Rowson GR, Zhu J, Nielsen T, Sahin D, Hiddemann W, Marcus RE, Davies A; PET investigators from the GALLIUM study. Prognostic value of end-of-induction PET response after first-line immunochemotherapy for follicular lymphoma (GALLIUM): secondary analysis of a randomised, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1530-1542. doi: 10.1016/S1470-2045(18)30618-1. Epub 2018 Oct 8.'}, {'pmid': '29856692', 'type': 'DERIVED', 'citation': 'Hiddemann W, Barbui AM, Canales MA, Cannell PK, Collins GP, Durig J, Forstpointner R, Herold M, Hertzberg M, Klanova M, Radford J, Seymour JF, Tobinai K, Trotman J, Burciu A, Fingerle-Rowson G, Wolbers M, Nielsen T, Marcus RE. Immunochemotherapy With Obinutuzumab or Rituximab for Previously Untreated Follicular Lymphoma in the GALLIUM Study: Influence of Chemotherapy on Efficacy and Safety. J Clin Oncol. 2018 Aug 10;36(23):2395-2404. doi: 10.1200/JCO.2017.76.8960. Epub 2018 Jun 1.'}, {'pmid': '28976863', 'type': 'DERIVED', 'citation': 'Marcus R, Davies A, Ando K, Klapper W, Opat S, Owen C, Phillips E, Sangha R, Schlag R, Seymour JF, Townsend W, Trneny M, Wenger M, Fingerle-Rowson G, Rufibach K, Moore T, Herold M, Hiddemann W. Obinutuzumab for the First-Line Treatment of Follicular Lymphoma. N Engl J Med. 2017 Oct 5;377(14):1331-1344. doi: 10.1056/NEJMoa1614598.'}]}, 'descriptionModule': {'briefSummary': "This open-label, randomized study will assess the efficacy and safety of obinutuzumab (RO5072759) in combination with chemotherapy compared to rituximab (MabThera/Rituxan) with chemotherapy followed by obinutuzumab or rituximab maintenance in participants with untreated advanced indolent non-Hodgkin's lymphoma. After the end of the induction period, participants achieving response (Complete response \\[CR\\] or partial response \\[PR\\]) will undergo a maintenance period continuing on the randomized antibody treatment alone every 2 months until disease progression for a total of 2 years. Anticipated time on study treatment is up to approximately 2.5 years. After maintenance or observation, participants will be followed for 5 years until progression. After progression, participants will be followed for new anti-lymphoma therapy and overall survival until the end of the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Cluster of differentiation 20 (CD20)-positive indolent B-cell non-Hodgkin's lymphoma (follicular lymphoma or splenic, nodal or extranodal marginal zone lymphoma)\n* Stage III or IV disease, or Stage II bulky disease (defined as tumor diameter greater than or equal to \\[\\>/=\\] 7 centimeters \\[cm\\])\n* For participants with follicular lymphoma: requirement for treatment according to Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria\n* For participants with symptomatic splenic, nodal, or non-gastric extranodal marginal zone lymphoma: disease that is de novo or has relapsed following local therapy (i.e. surgery or radiotherapy) and requires therapy as assessed by the investigator\n* At least one bi-dimensionally measurable lesion (greater than \\[\\>\\] 2 cm in its largest dimension by computed tomography \\[CT\\] scan or magnetic resonance imaging \\[MRI\\])\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n* Adequate hematologic function\n\nExclusion Criteria:\n\n* Central nervous system lymphoma, leptomeningeal lymphoma, or histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma\n* Grade 3b follicular lymphoma, small lymphocytic lymphoma or Waldenström's macroglobulinaemia\n* Ann Arbor Stage I disease\n* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy\n* Known hypersensitivity to any of the study drugs or sensitivity to murine products, or history of sensitivity to mannitol\n* For participants with follicular lymphoma: prior treatment for non-Hodgkin's lymphoma with chemotherapy, immunotherapy, or radiotherapy\n* For participants with non-follicular lymphoma: prior treatment with chemotherapy or immunotherapy\n* Regular treatment with corticosteroids during the 4 weeks prior to the start of Cycle 1\n* Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results\n* For participants who will be receiving cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP): left ventricular ejection fraction (LVEF) less than (\\<) 50% by multiple-gated acquisition (MUGA) scan or echocardiogram\n* History of prior other malignancy with the exception of curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time prior to study\n* Known active infection, or major episode of infection within 4 week prior to the start of Cycle 1\n* Vaccination with a live vaccine within 28 days prior to randomization\n* Recent major surgery (within 4 weeks prior to start of Cycle 1), other than for diagnosis\n* Abnormal laboratory values as defined by protocol for creatinine, creatinine clearance, aspartate transaminase (AST) or alanine transaminase (ALT), total bilirubin, international normalized ration (INR), partial thromboplastin time (PTT) or activated partial thromboplastin time (aPPT), unless these abnormalities are due to underlying lymphoma\n* Positive test results for human immunodeficiency virus (HIV), human T-lymphotropic virus 1 (HTLV1), hepatitis C or chronic hepatitis B\n* Pregnant or lactating women\n* Life expectancy \\<12 months\n* Participation in another clinical trial with drug intervention within 28 days prior to start of Cycle 1 and during study"}, 'identificationModule': {'nctId': 'NCT01332968', 'briefTitle': "A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': "A Multicenter, Phase III, Open-Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) Plus Chemotherapy Compared With Rituximab Plus Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders", 'orgStudyIdInfo': {'id': 'BO21223'}, 'secondaryIdInfos': [{'id': '2010-024132-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rituximab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Doxorubicin', 'Drug: Vincristine', 'Drug: Prednisone', 'Drug: Bendamustine', 'Drug: Rituximab']}, {'type': 'EXPERIMENTAL', 'label': 'Obinutuzumab+Chemotherapy', 'description': 'Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.', 'interventionNames': ['Drug: Obinutuzumab', 'Drug: Cyclophosphamide', 'Drug: Doxorubicin', 'Drug: Vincristine', 'Drug: Prednisone', 'Drug: Bendamustine']}], 'interventions': [{'name': 'Obinutuzumab', 'type': 'DRUG', 'otherNames': ['GA101; RO5072759'], 'description': 'Obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion will be administered on Day 1, 8, and 15 of Cycle 1 and then on Day 1 of each subsequent cycle during induction period and obinutuzumab 1000 mg IV infusion every 2 months during maintenance period.', 'armGroupLabels': ['Obinutuzumab+Chemotherapy']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Cyclophosphamide 750 mg/m\\^2 IV will be administered on Day 1 of each cycle during induction period.', 'armGroupLabels': ['Obinutuzumab+Chemotherapy', 'Rituximab+Chemotherapy']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'description': 'Doxorubicin 50 mg/m\\^2 IV will be administered on Day 1 of each cycle during induction period.', 'armGroupLabels': ['Obinutuzumab+Chemotherapy', 'Rituximab+Chemotherapy']}, {'name': 'Vincristine', 'type': 'DRUG', 'description': 'Vincristine 1.4 mg/m\\^2 (maximum 2 mg) IV will be administered on Day 1 of each cycle during induction period.', 'armGroupLabels': ['Obinutuzumab+Chemotherapy', 'Rituximab+Chemotherapy']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': 'Prednisone 100 mg (or equivalent prednisolone or methylprednisolone) will be administered orally on Days 1-5 of each cycle during induction period.', 'armGroupLabels': ['Obinutuzumab+Chemotherapy', 'Rituximab+Chemotherapy']}, {'name': 'Bendamustine', 'type': 'DRUG', 'description': 'Bendamustine 90 mg/m\\^2 IV infusion will be administered on Days 1 and 2 of each cycle during induction period.', 'armGroupLabels': ['Obinutuzumab+Chemotherapy', 'Rituximab+Chemotherapy']}, {'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['MabThera/Rituxan'], 'description': 'Rituximab 375 milligrams per square meter (mg/m\\^2) IV infusion will be administered on Day 1 of each cycle during induction period and rituximab 375 mg/m\\^2 every 2 months during maintenance period.', 'armGroupLabels': ['Rituximab+Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72762', 'city': 'Springdale', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Highlands Oncology Group', 'geoPoint': {'lat': 36.18674, 'lon': -94.12881}}, {'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'The Regents of the University of California; 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Herrenberger, Keitel-Wittig u. Kirsch', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '09113', 'city': 'Chemnitz', 'country': 'Germany', 'facility': 'Klinikum Chemnitz gGmbH Krankenhaus Küchwald Klinik f.Innere Medizin III', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'zip': '50924', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Klinik der Uni zu Köln; Klinik für Innere Medizin', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '06847', 'city': 'Dessau', 'country': 'Germany', 'facility': 'Städtisches Klinikum Dessau', 'geoPoint': {'lat': 51.83864, 'lon': 12.24555}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '99089', 'city': 'Erfurt', 'country': 'Germany', 'facility': 'HELIOS Klinikum Erfurt I.Medizinische Klinik', 'geoPoint': {'lat': 50.97734, 'lon': 11.03536}}, {'zip': '52249', 'city': 'Eschweiler', 'country': 'Germany', 'facility': 'St.-Antonius-Hospital gGmbH; Klinik für Hämatologie und Onkologie', 'geoPoint': {'lat': 50.81854, 'lon': 6.27184}}, {'zip': '45122', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60596', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Klinik Johann Wolfgang von Goethe Uni; Medizinische Klinik II', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Universitätsklinikum Freiburg; Klinik für Innere Medizin I; Hämatologie/Onkologie', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Uni Göttingen, Georg-August-Universität; Klinik für Hämatologie und Medizinische Onkologie', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '17475', 'city': 'Greifswald', 'country': 'Germany', 'facility': 'Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'zip': '58097', 'city': 'Hagen', 'country': 'Germany', 'facility': 'Kath. Krankenhaus Hagen gem. GmbH, St.-Josefs-Hospital; Klinik für Hämatologie und Onkologie', 'geoPoint': {'lat': 51.36081, 'lon': 7.47168}}, {'zip': '30171', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Onkologische Schwerpunktpraxis Dres. Bernd Gaede, Hans-Ulrich Ehlers, Ulrike Rodewig u.w.', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '69115', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Dres.Andreas Karcher und Stefan Fuxius', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '64421', 'city': 'Homburg/Saar', 'country': 'Germany', 'facility': 'Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I'}, {'zip': '07747', 'city': 'Jena', 'country': 'Germany', 'facility': 'Universitätsklinikum Jena; Klinik für Innere Medizin II', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'UKSH, Campus Kiel; Klinik für Innere Medizin II, Hämatologie und Internistische Onkologie', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '56068', 'city': 'Koblenz', 'country': 'Germany', 'facility': 'Institut für Versorgungsforschung in der Onkologie GbR Koblenz', 'geoPoint': {'lat': 50.35357, 'lon': 7.57883}}, {'zip': '84028', 'city': 'Landshut', 'country': 'Germany', 'facility': 'Tagesklinik Landshut; Hämatologie/Onkologie', 'geoPoint': {'lat': 48.52961, 'lon': 12.16179}}, {'zip': '66822', 'city': 'Lebach', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis für Hämatologie und Onkologie', 'geoPoint': {'lat': 49.41122, 'lon': 6.90988}}, {'zip': '04129', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Klinikum St.Georg gGmbH Klinik für Internistische Onkologie und Hämotologie', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '67063', 'city': 'Ludwigshafen', 'country': 'Germany', 'facility': 'Klinikum der Stadt Ludwigshafen; Medizinische Klinik A', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}, {'zip': '39104', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Onkologische Gemeinschaftspraxis', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '39120', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Otto von Guericke Uni Magdeburg Uniklinik; Hämatologie/Onkologie', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Uni. der Johannes Gutenberg-Universitaet Mainz; III. 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