Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-02-21 @ 11:35 PM
Study NCT ID:
NCT04182204
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2019-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Russia', 'Sweden'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'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': 'C000600736', 'term': 'polatuzumab vedotin'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, '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': 'AEs and SAEs: From treatment initiation until 90 days after the last dose of study drug or initiation of NALT (approximately 8.3 months for Stage 1 and 10.6 months for Stage 2). All-cause Mortality: Up to approximately 34 months', 'description': 'Safety population included all participants who received any amount of any study drug (regardless of the stage). 1 participant in each Pola-R-GemOx arm and R-GemOx arm of Stage 2 did not receive any treatment and were excluded from the safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Stage 1: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 milligrams mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 14, 'seriousNumAtRisk': 15, 'deathsNumAffected': 9, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Stage 2: R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.', 'otherNumAtRisk': 125, 'deathsNumAtRisk': 125, 'otherNumAffected': 111, 'seriousNumAtRisk': 125, 'deathsNumAffected': 83, 'seriousNumAffected': 39}, {'id': 'EG002', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.', 'otherNumAtRisk': 128, 'deathsNumAtRisk': 128, 'otherNumAffected': 119, 'seriousNumAtRisk': 128, 'deathsNumAffected': 68, 'seriousNumAffected': 49}, {'id': 'EG003', 'title': 'Pola-R-GemOx - Pooled', 'description': 'All participants who received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle either during safety run-in or RCT stage, were included in this arm. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.', 'otherNumAtRisk': 143, 'deathsNumAtRisk': 143, 'otherNumAffected': 133, 'seriousNumAtRisk': 143, 'deathsNumAffected': 77, 'seriousNumAffected': 51}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 54, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 101, 'numAffected': 48}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 103, 'numAffected': 50}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 14, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 14, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 49, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 71, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 77, 'numAffected': 27}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 45, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 96, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 104, 'numAffected': 34}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 25, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 35, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 87, 'numAffected': 47}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 94, 'numAffected': 51}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 72, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 128, 'numAffected': 50}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 133, 'numAffected': 54}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 60, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 62, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 65, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Device related thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 15, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 21, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 21, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 24, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 28, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hepatic cytolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 24, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 56, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 58, 'numAffected': 31}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 24, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 61, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 63, 'numAffected': 33}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 15, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 16, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Body temperature increased', 'stats': [{'groupId': 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143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Tumour fistulisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Neurotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Renal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Bronchial obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stage 1: Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From treatment initiation until 90 days after the last dose of study drug or initiation of non-protocol-specified anti-lymphoma treatment (NALT) (Up to approximately 8.3 months)', 'description': 'An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety run-in population included all participants who received any amount of any study drug during safety run-in stage.'}, {'type': 'PRIMARY', 'title': 'Stage 1: Number of Participants With Peripheral Neuropathy (PN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From treatment initiation until 90 days after the last dose of study drug or initiation of NALT (Up to approximately 8.3 months)', 'description': 'An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Participants receiving polatuzumab vedotin may develop PN, including peripheral sensory and/or motor neuropathy. Symptoms included hypoesthesia, hyperesthesia, paresthesia, dysesthesia, discomfort, a burning sensation, weakness, gait disturbance, loss of balance, orthostatic hypotension, syncope, or neuropathic pain.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety run-in population included all participants who received any amount of any study drug during safety run-in stage.'}, {'type': 'PRIMARY', 'title': 'Stage 2: Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '8.9', 'upperLimit': '15.8'}, {'value': '19.5', 'comment': 'The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '13.3', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0017', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.43', 'ciUpperLimit': '0.83', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to death (Up to approximately 34 months)', 'description': 'OS was defined as the time from randomization to the death from any cause during the study. Participants who were not reported as having died at the time of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization. Kaplan-Meier (KM) method was used to estimate median OS for each treatment arm.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Stage 1 and Stage 2: Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: R-GemOx', 'description': 'R-GemOx: Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG002', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin,1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '6.3'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '3.3'}, {'value': '7.4', 'groupId': 'OG002', 'lowerLimit': '6.2', 'upperLimit': '11.7'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.37', 'ciLowerLimit': '0.27', 'ciUpperLimit': '0.51', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to first occurrence of PD or death (Up to approximately 34 months)', 'description': 'PFS=time from randomization to the first occurrence of disease progression (PD) (based on either: PET-CT data/not including any PET data), as determined by investigator, per Lugano response criteria or death due to any cause, whichever occurs first. PD based on PET-CT data=score 4 (uptake moderately \\> liver) or 5 (uptake markedly higher than liver \\&/or new lesions) on 5-point scale (5PS) with an increase in intensity of uptake from baseline at individual target nodes/nodal masses and/or new FDG-avid foci extranodal lesions consistent with lymphoma at interim or end-of-treatment assessment. New lesions: New FDG-avid foci consistent with lymphoma rather than another etiology, Bone marrow: New/recurrent FDG-avid foci. Participants who did not report PD nor died at time of analysis were censored on the date of last evaluable tumor assessment if post-baseline tumor assessment or on date of randomization if no post-baseline tumor assessment. KM methodology was used to estimate median PFS.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety run-in population included all participants who received any amount of any study drug during stage 1. ITT population included all randomized participants in stage 2.'}, {'type': 'SECONDARY', 'title': 'Stage 2: Complete Response Rate (CRR), as Determined by an Independent Review Committee (IRC) at the End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: R-GemOx', 'description': 'R-GemOx: Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '12.60', 'upperLimit': '27.00'}, {'value': '40.3', 'groupId': 'OG001', 'lowerLimit': '31.77', 'upperLimit': '49.30'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Response Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.26', 'ciLowerLimit': '9.58', 'ciUpperLimit': '32.94', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 8.5 months', 'description': "CRR was defined as the percentage of participants who had a complete metabolic response (CMR) based on positron emission tomography-computed tomography (PET-CT) according to Lugano response criteria at the end of treatment as determined by IRC. CMR was defined as score 1, 2, or 3 (1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \\>mediastinum but ≤ liver) with or without a residual mass on 5PS at lymph nodes and extra lymphatic sites. In Waldeyer's ring or extranodal sites with high physiologic uptake or with activation within spleen or marrow (e.g., with chemotherapy/myeloid colony-stimulating factors), uptake may be greater than normal mediastinum and/or liver. In this circumstance, CMR was inferred if uptake at sites of initial involvement was no greater than surrounding normal tissue even if the tissue had high physiologic uptake; no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Percentages are rounded off.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Stage 2: Objective Response Rate (ORR) as Determined by an IRC at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: R-GemOx', 'description': 'R-GemOx: Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000', 'lowerLimit': '17.37', 'upperLimit': '33.07'}, {'value': '52.7', 'groupId': 'OG001', 'lowerLimit': '43.74', 'upperLimit': '61.56'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Response Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.11', 'ciLowerLimit': '15.89', 'ciUpperLimit': '40.33', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 8.5 months', 'description': "ORR=percentage of participants with CMR/partial metabolic responses (PMR), based on PET-CT per Lugano response criteria as per an IRC. CMR=score 1, 2, or 3 with/ without a residual mass on 5PS at lymph nodes (LN) \\& extra lymphatic sites. In Waldeyer's ring or extra nodal sites with high physiologic uptake or with activation within spleen/marrow, uptake may be greater than normal mediastinum \\&/or liver. In this case, CMR was inferred if uptake at sites of initial involvement was no greater than surrounding normal tissue even if the tissue had high physiologic uptake; no new lesions \\& no evidence of FDG-avid disease in bone marrow. PMR=score 4 or 5 on 5PS (4=uptake moderately \\> liver; 5=uptake markedly higher than liver \\&/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size at LN \\& extra lymphatic sites; no new lesions \\& residual uptake higher than uptake in normal marrow but reduced compared with baseline. Percentages are rounded off.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Stage 1 and Stage 2: Percentage of Participants With Best Overall Response (BOR) as Determined by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: R-GemOx', 'description': 'R-GemOx: Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG002', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin,1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000', 'lowerLimit': '21.27', 'upperLimit': '73.41'}, {'value': '34.9', 'groupId': 'OG001', 'lowerLimit': '26.65', 'upperLimit': '43.92'}, {'value': '65.1', 'groupId': 'OG002', 'lowerLimit': '56.23', 'upperLimit': '73.29'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Response Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.20', 'ciLowerLimit': '17.71', 'ciUpperLimit': '42.68', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 34 months', 'description': 'BOR was defined as the best response while on study (based on PET-CT or CT data) according to Lugano response criteria, as determined by the investigator. CMR and PMR based on PET-CT data were defined as outlined in the ORR outcome measure (OM) number 8. CT-based complete radiologic response was defined as target lymphatic nodes/nodal masses regression to ≤ 1.5 centimeters (cm) in longest transverse diameter of a lesion (LDi); no extralymphatic sites of disease; absence of non-measured lesion; enlarged organs regress to normal; no new lesions and bone marrow normal by morphology, if indeterminate, immunohistochemistry (IHC) negative. CT-based partial response was defined as ≥50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of up to 6 target measurable nodes and extra nodal sites; absent/normal, regressed, but no increase in non-measured lesions; spleen regressed by \\>50% in length beyond normal and no new lesions. Percentages are rounded off.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety run-in population included all participants who received any amount of any study drug during stage 1. ITT population included all randomized participants in stage 2.'}, {'type': 'SECONDARY', 'title': 'Stage 1 and Stage 2: CRR as Determined by the Investigator at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: R-GemOx', 'description': 'R-GemOx: Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG002', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin,1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '4.33', 'upperLimit': '48.09'}, {'value': '18.3', 'groupId': 'OG001', 'lowerLimit': '11.94', 'upperLimit': '26.12'}, {'value': '35.7', 'groupId': 'OG002', 'lowerLimit': '27.42', 'upperLimit': '44.57'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Response Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.40', 'ciLowerLimit': '5.95', 'ciUpperLimit': '28.86', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Stage 1: Up to approximately 6.2 months and Stage 2: Up to approximately 8.5 months', 'description': "CRR was defined as the percentage of participants who had CMR based positron emission tomography-computed tomography (PET-CT) according to Lugano response criteria at the end of treatment as determined by investigator. CMR was defined as score 1, 2, or 3 (1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \\>mediastinum but ≤ liver) with or without a residual mass on 5PS at lymph nodes and extra lymphatic sites. In Waldeyer's ring or extranodal sites with high physiologic uptake or with activation within spleen or marrow (e.g., with chemotherapy/myeloid colony-stimulating factors), uptake may be greater than normal mediastinum and/or liver. In this circumstance, CMR was inferred if uptake at sites of initial involvement is no greater than surrounding normal tissue even if the tissue has high physiologic uptake; no new lesions and no evidence of FDG-avid disease in bone marrow. Percentages are rounded off.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety run-in population included all participants who received any amount of any study drug during stage 1. ITT population included all randomized participants in stage 2.'}, {'type': 'SECONDARY', 'title': 'Stage 1 and Stage 2: ORR as Determined by the Investigator at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: R-GemOx', 'description': 'R-GemOx: Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG002', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin,1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000', 'lowerLimit': '7.79', 'upperLimit': '55.10'}, {'value': '24.6', 'groupId': 'OG001', 'lowerLimit': '17.37', 'upperLimit': '33.07'}, {'value': '45.0', 'groupId': 'OG002', 'lowerLimit': '36.20', 'upperLimit': '53.96'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Response Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.36', 'ciLowerLimit': '8.16', 'ciUpperLimit': '32.56', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Stage 1: Up to approximately 6.2 months and Stage 2: Up to approximately 8.5 months', 'description': "ORR=percentage of participants with CMR/PMR, based on PET-CT as determined by investigator per Lugano response criteria. CMR=score 1, 2, or 3 with/ without a residual mass on 5PS at LN \\& extra lymphatic sites. In Waldeyer's ring or extra nodal sites with high physiologic uptake or with activation within spleen/marrow, uptake may be greater than normal mediastinum \\&/or liver. In this case, CMR was inferred if uptake at sites of initial involvement was no greater than surrounding normal tissue even if the tissue had high physiologic uptake; no new lesions \\& no evidence of FDG-avid disease in bone marrow. PMR=score 4 or 5 on 5PS (4=uptake moderately \\> liver; 5=uptake markedly higher than liver \\&/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size at LN \\& extra lymphatic sites; no new lesions \\& residual uptake higher than uptake in normal marrow but reduced compared with baseline. Percentages are rounded off.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety run-in population included all participants who received any amount of any study drug during stage 1. ITT population included all randomized participants in stage 2.'}, {'type': 'SECONDARY', 'title': 'Stage 2: Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: R-GemOx', 'description': 'R-GemOx: Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '26.9'}, {'value': '11.8', 'groupId': 'OG001', 'lowerLimit': '8.6', 'upperLimit': '15.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 34 months', 'description': 'DOR=time from the date of the first occurrence of a documented objective response (complete or partial response \\[CR/PR\\]) (based on PET-CT or CT data) as determined by the investigator, using Lugano response criteria, until PD (based on either response: including PET-CT data or not including any PET data) or death, whichever occurred first. CMR and PMR based on PET-CT data were defined as outlined in the ORR OM. CT-based complete and partial response were defined as outlined in the BOR OM. PD defined as outlined in the PFS OM.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'DOR-evaluable population included all participants who had an objective response (CR or PR).'}, {'type': 'SECONDARY', 'title': 'Stage 1 and Stage 2: Event-free Survival (EFSeff)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: R-GemOx', 'description': 'R-GemOx: Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG002', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin,1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '6.3'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '3.3'}, {'value': '6.8', 'groupId': 'OG002', 'lowerLimit': '5.9', 'upperLimit': '9.3'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.40', 'ciLowerLimit': '0.30', 'ciUpperLimit': '0.53', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 34 months', 'description': 'EFSeff was defined as the time from randomization to first to the earliest occurrence of the following: PD or relapse using Lugano response criteria (based on either response: including PET-CT data or not including any PET data); death due to any cause or initiation of any NALT. PD based on PET-CT data was defined as score 4 or 5 on 5PS with an increase in intensity of uptake from baseline at individual target nodes/nodal masses and/or new FDG-avid foci extranodal lesions consistent with lymphoma at interim or end-of-treatment assessment. New lesions: New FDG-avid foci consistent with lymphoma rather than another etiology, Bone marrow: New or recurrent FDG-avid foci. Participants with no EFSeff events were censored at the time of the last evaluable tumor assessment if post-baseline assessments were available and participants who did not undergo a post-baseline tumor assessment were censored at the time of randomization. KM method was used to estimate median EFS for each treatment arm.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety run-in population included all participants who received any amount of any study drug during stage 1. ITT population included all randomized participants in stage 2.'}, {'type': 'SECONDARY', 'title': 'Stage 2: Time to Deterioration in Physical Functioning as Measured by the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire, Core 30 (EORTC QLQ-C30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: R-GemOx', 'description': 'R-GemOx: Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '3.0'}, {'value': '8.1', 'comment': 'The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.57', 'ciLowerLimit': '0.40', 'ciUpperLimit': '0.83', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 34 months', 'description': 'Time to deterioration was defined as the time from randomization to the first documentation of a 10-point decrease in EORTC QLQ-C30 physical functioning scale. EORTC QLQ-C30 consists of 30 questions assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health status and quality of life (GHS/QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The functioning items were scored on a 4-point scale that ranged from "not at all" to "very much". Raw average scale scores were linearly transformed to range 0-100 with higher scores indicating higher response levels (i.e. higher functioning). KM method was used to estimate median time to deterioration for each treatment arm.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Stage 2: Time to Deterioration in Fatigue Scale as Measured by the EORTC QLQ-C30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: R-GemOx', 'description': 'R-GemOx: Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '2.8'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '2.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.17', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 34 months', 'description': 'Time to deterioration was defined as the time from randomization to the first documentation of a 10-point increase from baseline in EORTC QLQ-C30 fatigue scale. EORTC QLQ-C30 consists of 30 questions assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), GHS/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The symptom scale (fatigue) was scored on a 4-point scale that ranged from "not at all" to "very much". Raw average scale scores were linearly transformed to range 0-100 with higher scores indicating higher response levels (i.e. higher symptom severity). KM method was used to estimate median time to deterioration for each treatment arm.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Stage 2: Time to Deterioration in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Lymphoma Subscale (FACT-Lym LymS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: R-GemOx', 'description': 'R-GemOx: Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '3.2'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '7.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.45', 'ciUpperLimit': '0.91', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 34 months', 'description': 'Time to deterioration was defined as the time from randomization to the first documentation of a \\>3-point decrease from baseline in FACT-Lym LymS. The FACT-Lym subscale has 4 domains: physical well-being, social/family well-being, emotional well-being, functional well-being and lymphoma-specific subscale (LymS). The FACT-Lym LYMS consists of common lymphoma disease and/or treatment-related symptoms (e.g., pain, fever, swelling, night sweats, insomnia, itching, weight loss, fatigue, and loss of appetite). FACT-Lym LYMS contains 15 items scored from 0-4, where 0="Not at all" and 4="very much". Scale score range is from 0 to 60. Higher score indicates better quality of life. KM method was used to estimate the median time to deterioration for each treatment arm.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Stage 2: Change From Baseline in Physical Functioning as Measured by EORTC QLQ-C30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: R-GemOx', 'description': 'R-GemOx: Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.65', 'spread': '22.83', 'groupId': 'OG000'}, {'value': '71.08', 'spread': '25.09', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.88', 'spread': '16.60', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '16.74', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.10', 'spread': '19.81', 'groupId': 'OG000'}, {'value': '2.16', 'spread': '19.57', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.28', 'spread': '17.00', 'groupId': 'OG000'}, {'value': '2.68', 'spread': '20.65', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.76', 'spread': '18.37', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '20.39', 'groupId': 'OG001'}]}]}, {'title': 'Change at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.65', 'spread': '19.00', 'groupId': 'OG000'}, {'value': '-3.70', 'spread': '22.56', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.91', 'spread': '19.66', 'groupId': 'OG000'}, {'value': '-0.80', 'spread': '20.10', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 02', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.53', 'spread': '17.54', 'groupId': 'OG000'}, {'value': '2.28', 'spread': '20.11', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 03', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.29', 'spread': '19.50', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '18.51', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 04', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.67', 'spread': '15.87', 'groupId': 'OG000'}, {'value': '0.65', 'spread': '14.54', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 05', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.88', 'spread': '19.28', 'groupId': 'OG000'}, {'value': '-2.53', 'spread': '18.89', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 06', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.00', 'spread': '15.48', 'groupId': 'OG000'}, {'value': '1.54', 'spread': '16.79', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 07', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.17', 'spread': '17.43', 'groupId': 'OG000'}, {'value': '6.67', 'spread': '17.95', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 08', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.44', 'spread': '21.26', 'groupId': 'OG000'}, {'value': '5.45', 'spread': '16.01', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 09', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': '17.26', 'groupId': 'OG000'}, {'value': '8.48', 'spread': '19.57', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.67', 'spread': '18.50', 'groupId': 'OG000'}, {'value': '5.33', 'spread': '19.66', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.00', 'spread': '11.39', 'groupId': 'OG000'}, {'value': '11.67', 'spread': '15.75', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.33', 'spread': '11.55', 'groupId': 'OG000'}, {'value': '16.67', 'spread': '23.57', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.67', 'spread': 'NA', 'comment': 'The standard deviation was not estimable for a single participant.', 'groupId': 'OG000'}, {'value': '16.67', 'spread': '23.57', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'spread': 'NA', 'comment': 'The standard deviation was not estimable for a single participant.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1 of Cycle 2, 3, 5 and 7 (Cycle length= 21 days), end of treatment, long-term follow-up visits every two months (up to approximately 34 months)', 'description': 'EORTC QLQ-C30 consists of 30 questions assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), GHS/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The functioning items were scored on a 4-point scale that ranged from "not at all" to "very much". Raw average scale scores were linearly transformed to range 0-100 with higher scores indicating higher response levels (i.e. higher physical functioning).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants. Number analyzed is the number of participants with data available for analysis at the specified timepoint. Participants may have been lost to follow-up/did not complete the specified visit during the study.'}, {'type': 'SECONDARY', 'title': 'Stage 2: Change From Baseline in Fatigue Scale as Measured by EORTC QLQ-C30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: R-GemOx', 'description': 'R-GemOx: Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.99', 'spread': '25.00', 'groupId': 'OG000'}, {'value': '35.13', 'spread': '28.01', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.81', 'spread': '25.16', 'groupId': 'OG000'}, {'value': '2.57', 'spread': '20.30', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.04', 'spread': '23.08', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '24.39', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.26', 'spread': '25.44', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '24.88', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.90', 'spread': '17.56', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '27.38', 'groupId': 'OG001'}]}]}, {'title': 'Change at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.43', 'spread': '26.70', 'groupId': 'OG000'}, {'value': '6.99', 'spread': '28.87', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.03', 'spread': '18.84', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '23.37', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 02', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.77', 'spread': '15.96', 'groupId': 'OG000'}, {'value': '-4.97', 'spread': '19.96', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 03', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.59', 'spread': '24.60', 'groupId': 'OG000'}, {'value': '-6.27', 'spread': '18.52', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 04', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.71', 'spread': '17.48', 'groupId': 'OG000'}, {'value': '-9.68', 'spread': '18.97', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 05', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '24.34', 'groupId': 'OG000'}, {'value': '-7.66', 'spread': '21.23', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 06', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '25.66', 'groupId': 'OG000'}, {'value': '-7.26', 'spread': '12.94', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 07', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.33', 'spread': '17.57', 'groupId': 'OG000'}, {'value': '-8.50', 'spread': '16.91', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 08', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '17.21', 'groupId': 'OG000'}, {'value': '-10.10', 'spread': '12.62', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 09', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '23.31', 'groupId': 'OG000'}, {'value': '-12.12', 'spread': '16.82', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.89', 'spread': '19.88', 'groupId': 'OG000'}, {'value': '-2.22', 'spread': '4.97', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.11', 'spread': '12.83', 'groupId': 'OG000'}, {'value': '-8.33', 'spread': '16.67', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '19.24', 'groupId': 'OG000'}, {'value': '-11.11', 'spread': '15.71', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.22', 'spread': 'NA', 'comment': 'The standard deviation was not estimable for a single participant.', 'groupId': 'OG000'}, {'value': '-11.11', 'spread': '15.71', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-22.22', 'spread': 'NA', 'comment': 'The standard deviation was not estimable for a single participant.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1 of Cycles 2, 3, 5 and 7 (Cycle length= 21 days), end of treatment, long-term follow-up visits every two months (up to approximately 34 months)', 'description': 'EORTC QLQ-C30 consists of 30 questions assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), GHS/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The symptom scale (fatigue) were scored on a 4-point scale that ranged from "not at all" to "very much". Raw average scale scores were linearly transformed to range 0-100 with higher scores indicating higher response levels (i.e. higher symptom severity). A positive change from baseline indicates an improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants. Number analyzed is the number of participants with data available for analysis at the specified time point. Participants may have been lost to follow-up/did not complete the specified visit during the study.'}, {'type': 'SECONDARY', 'title': 'Stage 2: Change From Baseline in FACT-Lym LYMS Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: R-GemOx', 'description': 'R-GemOx: Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.73', 'spread': '10.88', 'groupId': 'OG000'}, {'value': '42.49', 'spread': '10.94', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.49', 'spread': '9.37', 'groupId': 'OG000'}, {'value': '2.12', 'spread': '8.38', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.71', 'spread': '8.17', 'groupId': 'OG000'}, {'value': '2.66', 'spread': '9.22', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.95', 'spread': '8.15', 'groupId': 'OG000'}, {'value': '3.53', 'spread': '8.10', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.32', 'spread': '8.23', 'groupId': 'OG000'}, {'value': '2.69', 'spread': '10.45', 'groupId': 'OG001'}]}]}, {'title': 'Change at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.71', 'spread': '10.34', 'groupId': 'OG000'}, {'value': '2.34', 'spread': '11.09', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '13.10', 'groupId': 'OG000'}, {'value': '2.88', 'spread': '10.03', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 02', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.22', 'spread': '9.28', 'groupId': 'OG000'}, {'value': '5.32', 'spread': '8.15', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 03', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.08', 'spread': '7.31', 'groupId': 'OG000'}, {'value': '3.90', 'spread': '7.32', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 04', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.00', 'spread': '6.18', 'groupId': 'OG000'}, {'value': '4.29', 'spread': '6.47', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 05', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.00', 'spread': '9.56', 'groupId': 'OG000'}, {'value': '4.07', 'spread': '6.87', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 06', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.89', 'spread': '6.75', 'groupId': 'OG000'}, {'value': '4.15', 'spread': '6.16', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 07', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.29', 'spread': '7.54', 'groupId': 'OG000'}, {'value': '4.65', 'spread': '7.56', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 08', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.00', 'spread': '4.53', 'groupId': 'OG000'}, {'value': '5.82', 'spread': '5.46', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 09', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.80', 'spread': '5.81', 'groupId': 'OG000'}, {'value': '7.82', 'spread': '6.63', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.50', 'spread': '7.23', 'groupId': 'OG000'}, {'value': '4.00', 'spread': '3.32', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.67', 'spread': '7.02', 'groupId': 'OG000'}, {'value': '6.75', 'spread': '5.44', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.50', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '4.50', 'spread': '4.95', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.00', 'spread': 'NA', 'comment': 'The standard deviation was not estimable for a single participant.', 'groupId': 'OG000'}, {'value': '4.00', 'spread': '4.24', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.00', 'spread': 'NA', 'comment': 'The standard deviation was not estimable for a single participant.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1 of Cycle 2, 3, 5 and 7 (Cycle length= 21 days), end of treatment, long-term follow-up visits every two months (up to approximately 34 months)', 'description': 'The FACT-Lym subscale has 4 domains: physical well-being, social/family well-being, emotional well-being, functional well-being and lymphoma-specific subscale (LymS). The FACT-Lym LYMS consists of common lymphoma disease and/or treatment-related symptoms (e.g., pain, fever, swelling, night sweats, insomnia, itching, weight loss, fatigue, and loss of appetite). FACT-Lym LYMS contains 15 items scored from 0-4, where 0="Not at all" and 4="very much". Scale score range is from 0 to 60. Higher score indicates better quality of life. A positive change from baseline indicates an improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants. Number analyzed is the number of participants with data available for analysis at the specified time point. Participants may have been lost to follow-up/did not complete the specified visit during the study.'}, {'type': 'SECONDARY', 'title': 'Stage 2: Change From Baseline in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity 12-Item (FACT/GOG-NTX-12) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin,1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.67', 'spread': '6.70', 'groupId': 'OG000'}, {'value': '40.37', 'spread': '8.32', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.56', 'spread': '5.60', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '6.87', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.35', 'spread': '4.91', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '8.01', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.44', 'spread': '6.82', 'groupId': 'OG000'}, {'value': '-0.78', 'spread': '7.58', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.35', 'spread': '4.54', 'groupId': 'OG000'}, {'value': '-1.68', 'spread': '7.95', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.02', 'spread': '5.47', 'groupId': 'OG000'}, {'value': '-3.48', 'spread': '8.92', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.00', 'spread': '4.77', 'groupId': 'OG000'}, {'value': '-4.25', 'spread': '9.97', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.62', 'spread': '4.95', 'groupId': 'OG000'}, {'value': '-5.08', 'spread': '10.41', 'groupId': 'OG001'}]}]}, {'title': 'Change at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.80', 'spread': '7.65', 'groupId': 'OG000'}, {'value': '-5.96', 'spread': '11.05', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.91', 'spread': '9.11', 'groupId': 'OG000'}, {'value': '-9.50', 'spread': '11.00', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 02', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.77', 'spread': '7.00', 'groupId': 'OG000'}, {'value': '-6.86', 'spread': '7.75', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 03', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.73', 'spread': '7.22', 'groupId': 'OG000'}, {'value': '-7.73', 'spread': '7.04', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 04', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.85', 'spread': '6.35', 'groupId': 'OG000'}, {'value': '-5.18', 'spread': '5.96', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 05', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.55', 'spread': '3.91', 'groupId': 'OG000'}, {'value': '-4.92', 'spread': '5.85', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 06', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.20', 'spread': '5.22', 'groupId': 'OG000'}, {'value': '-4.58', 'spread': '6.79', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 07', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.00', 'spread': '6.55', 'groupId': 'OG000'}, {'value': '-3.62', 'spread': '6.18', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 08', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.83', 'spread': '5.71', 'groupId': 'OG000'}, {'value': '-3.05', 'spread': '7.02', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 09', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.83', 'spread': '5.56', 'groupId': 'OG000'}, {'value': '-4.20', 'spread': '4.42', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.20', 'spread': '7.40', 'groupId': 'OG000'}, {'value': '-4.60', 'spread': '6.02', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.50', 'spread': '4.80', 'groupId': 'OG000'}, {'value': '-1.50', 'spread': '1.91', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.33', 'spread': '4.16', 'groupId': 'OG000'}, {'value': '-1.50', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.00', 'spread': 'NA', 'comment': 'The standard deviation was not estimable for a single participant.', 'groupId': 'OG000'}, {'value': '-2.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.00', 'spread': 'NA', 'comment': 'The standard deviation was not estimable for a single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Change at Long-term Follow-up 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7 and 8 (Cycle length= 21 days), end of treatment, long-term follow-up visits every two months (up to approximately 34 months)', 'description': 'The FACT/GOG-NTX scale provides a targeted assessment of symptoms of peripheral neuropathy, including sensory, motor, and auditory problems and cold sensitivity. It contains 12 items scored from 0-4, where 0="Not at all" and 4="very much". Scores are summed for a range of 12-44, with lower scores indicating more severe neurotoxicity. Participants completed assessments until progression or non-protocol-specified anti-lymphoma treatment (NALT). Only records on or before the first NALT were summarized.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety run-in population included all participants who received any amount of any study drug during safety run-in stage. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at the specified timepoints. Participants may have been lost to follow-up/did not complete the specified visit during the study.'}, {'type': 'SECONDARY', 'title': 'Stage 2: Percentage of Participants With Clinically Meaningful Improvement in EORTC QLQ-C30 Physical Functioning Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: R-GemOx', 'description': 'R-GemOx: Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.0', 'groupId': 'OG000', 'lowerLimit': '23.02', 'upperLimit': '39.80'}, {'value': '41.1', 'groupId': 'OG001', 'lowerLimit': '32.50', 'upperLimit': '50.09'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Response Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.13', 'ciLowerLimit': '-2.37', 'ciUpperLimit': '22.63', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 34 months', 'description': 'EORTC QLQ-C30 consists of 30 questions assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), GHS/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The functioning items were scored on a 4-point scale that ranged from "not at all" to "very much". Raw average scale scores were linearly transformed to range 0-100 with higher scores indicating higher response levels (i.e. higher functioning). Clinically meaningful improvement was defined as a participant with at least a 7 point scale score increase.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Stage 2.'}, {'type': 'SECONDARY', 'title': 'Stage 2: Percentage of Participants With Clinically Meaningful Improvement in EORTC QLQ-C30 Fatigue Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: R-GemOx', 'description': 'R-GemOx: Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.0', 'groupId': 'OG000', 'lowerLimit': '37.12', 'upperLimit': '55.14'}, {'value': '55.8', 'groupId': 'OG001', 'lowerLimit': '46.81', 'upperLimit': '64.55'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Response Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.78', 'ciLowerLimit': '-3.22', 'ciUpperLimit': '22.78', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 34 months', 'description': 'EORTC QLQ-C30 consists of 30 questions assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), GHS/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The symptom items were scored on a 4-point scale that ranged from "not at all" to "very much". Raw average scale scores were linearly transformed to range 0-100 with higher scores indicating higher response levels (i.e. higher symptom severity). Clinically meaningful improvement was defined as a participant with at least a 9 point scale score decrease.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Stage 2.'}, {'type': 'SECONDARY', 'title': 'Stage 2: Percentage of Participants With Clinically Meaningful Improvement in FACT-Lym LYMS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: R-GemOx', 'description': 'R-GemOx: Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.4', 'groupId': 'OG000', 'lowerLimit': '39.42', 'upperLimit': '57.48'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '57.83', 'upperLimit': '74.72'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Response Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.25', 'ciLowerLimit': '5.54', 'ciUpperLimit': '30.97', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 34 months', 'description': 'The FACT-Lym subscale has 4 domains: physical well-being, social/family well-being, emotional well-being, functional well-being and lymphoma-specific subscale (LymS). The FACT-Lym LYMS consists of common lymphoma disease and/or treatment-related symptoms (e.g., pain, fever, swelling, night sweats, insomnia, itching, weight loss, fatigue, and loss of appetite). FACT-Lym LYMS contains 15 items scored from 0-4, where 0="Not at all" and 4="very much". Scale score range is from 0 to 60. Higher score indicates better quality of life. Clinically meaningful improvement was defined as a 3-point increase from baseline.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Stage 2.'}, {'type': 'SECONDARY', 'title': 'Stage 2: Number of Participants With AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: R-GemOx', 'description': 'R-GemOx: Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From treatment initiation until 90 days after the last dose of study drug or initiation of NALT (approximately 10.6 months)', 'description': 'An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety-evaluable population included all participants who received any amount of any study drug (regardless of the stage).'}, {'type': 'SECONDARY', 'title': 'Stage 2: Number of Participants With PN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: R-GemOx', 'description': 'R-GemOx: Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From treatment initiation until 90 days after the last dose of study drug or initiation of NALT (approximately 10.6 months)', 'description': 'An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Participants receiving polatuzumab vedotin may develop PN, including peripheral sensory and/or motor neuropathy. Symptoms included hypoesthesia, hyperesthesia, paresthesia, dysesthesia, discomfort, a burning sensation, weakness, gait disturbance, loss of balance, orthostatic hypotension, syncope, or neuropathic pain.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety-evaluable population included all participants who received any amount of any study drug (regardless of the stage).'}, {'type': 'SECONDARY', 'title': 'Stage 1 and Stage 2: Number of Participants With Dose Modification for Polatuzumab Vedotin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin,1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Stage 1: Up to approximately 5.3 months and Stage 2: Up to approximately 7.6 months', 'description': "Dose modifications (interruptions/reductions) were based on physical examination findings, observed toxicities, and laboratory results obtained within 72 hours before study treatment administration. The determination of all dose modifications was made based on the investigator's assessment of ongoing clinical benefit with continuing study treatment. Dosing occurred only when a participant's clinical assessment and laboratory test values were acceptable.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received any amount of any study drug (regardless of the stage).'}, {'type': 'SECONDARY', 'title': 'Stage 1 and Stage 2: Dose Intensity of Polatuzumab Vedotin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin,1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.60', 'spread': '11.23', 'groupId': 'OG000'}, {'value': '92.81', 'spread': '10.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Stage 1: Up to approximately 5.3 months and Stage 2: Up to approximately 7.6 months', 'description': 'Dose intensity = (total dose actually received divided by the expected total dose)\\*100. Expected total dose for dose intensity accounting for delay/reduction is based on the expected number of cycles between the first and last exposure of each drug. Percentage of dose intensity accounting for delay/reduction in dose by the participants in each arm is reported here.', 'unitOfMeasure': 'percentage of dose', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received any amount of any study drug (regardless of the stage).'}, {'type': 'SECONDARY', 'title': 'Stage 1: OS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'comment': 'The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the death (up to approximately 34 months)', 'description': 'OS was defined as the time from randomization to the death from any cause during the study. Participants who were not reported as having died at the time of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization. KM method was used to estimate median OS for each treatment arm.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety run-in population included all participants who received any amount of any study drug during safety run-in stage.'}, {'type': 'SECONDARY', 'title': 'Stage 1 and Stage 2: Percentage of Participants With Anti-drug Antibodies (ADAs) to Polatuzumab Vedotin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'OG001', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin,1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 34 months', 'description': 'Treatment emergent ADA-positive participants after drug administration were determined for participants exposed to polatuzumab vedotin. Participants positive for treatment emergent ADA were defined as the number of post-baseline evaluable participants determined to have treatment-induced ADA or treatment-enhanced ADA during the study period. Treatment-induced ADA = a participant with negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 t.u. greater than the baseline titer result. Percentages are rounded off.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity-evaluable population included all participants who received at least one dose of polatuzumab vedotin with at least one evaluable post-baseline ADA sample.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stage 1: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 milligrams per square meter (mg/m\\^2), intravenously (IV), followed by polatuzumab vedotin, 1.8 milligrams per kilogram (mg/kg), IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'FG001', 'title': 'Stage 2: R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'FG002', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}], 'periods': [{'title': 'Safety Run-in', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Randomized Controlled Trial', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '126'}, {'groupId': 'FG002', 'numSubjects': '129'}]}, {'type': 'Safety-evaluable Population', 'comment': 'Safety-evaluable population included all participants who received any amount of any study drug (regardless of the stage). One participant in the Pola-R-GemOx (randomized) arm and one participant in the R-GemOx (randomized) arm did not receive any treatment and were excluded from the safety-evaluable population.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '125'}, {'groupId': 'FG002', 'numSubjects': '128'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '94'}, {'groupId': 'FG002', 'numSubjects': '74'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '83'}, {'groupId': 'FG002', 'numSubjects': '66'}]}]}], 'recruitmentDetails': 'A total of 270 participants with relapsed/refractory (r/r) diffuse large b-cell lymphoma (DLBCL) took part in the study at 64 investigative sites in 16 countries from 07 February 2020 to 29 November 2024.', 'preAssignmentDetails': 'The study was divided into 2 stages: Stage 1, or safety run-in (SRI), and Stage 2, or randomized controlled trial (RCT). Participants received polatuzumab vedotin in combination with rituximab + gemcitabine + oxaliplatin (Pola-R-GemOx) during the SRI stage. Participants were randomized in a 1:1 ratio to receive either Pola-R-GemOx or rituximab + gemcitabine + oxaliplatin (R-GemOx) in the RCT stage.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}, {'value': '270', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Stage 1: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'BG001', 'title': 'Stage 2: R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV on Day 1, followed by gemcitabine, 1000 mg/m\\^2, IV and oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'BG002', 'title': 'Stage 2: Pola-R-GemOx', 'description': 'Participants received rituximab, 375 mg/m\\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\\^2, IV followed by oxaliplatin 100 mg/m\\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.7', 'spread': '12.6', 'groupId': 'BG000'}, {'value': '62.2', 'spread': '13.9', 'groupId': 'BG001'}, {'value': '63.0', 'spread': '14.5', 'groupId': 'BG002'}, {'value': '63.1', 'spread': '14.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '200', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '130', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Multiple', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Enrolled population included all enrolled participants (regardless of the stage).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-06', 'size': 5302568, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-11-25T05:55', 'hasProtocol': True}, {'date': '2024-05-14', 'size': 964086, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-11-25T05:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In stage 1 participants are all assigned to one group. In stage 2 participants are assigned to two groups in parallel for the duration of the study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-19', 'studyFirstSubmitDate': '2019-11-18', 'resultsFirstSubmitDate': '2025-11-25', 'studyFirstSubmitQcDate': '2019-11-27', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-19', 'studyFirstPostDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stage 1: Number of Participants With Adverse Events (AEs)', 'timeFrame': 'From treatment initiation until 90 days after the last dose of study drug or initiation of non-protocol-specified anti-lymphoma treatment (NALT) (Up to approximately 8.3 months)', 'description': 'An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.'}, {'measure': 'Stage 1: Number of Participants With Peripheral Neuropathy (PN)', 'timeFrame': 'From treatment initiation until 90 days after the last dose of study drug or initiation of NALT (Up to approximately 8.3 months)', 'description': 'An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Participants receiving polatuzumab vedotin may develop PN, including peripheral sensory and/or motor neuropathy. Symptoms included hypoesthesia, hyperesthesia, paresthesia, dysesthesia, discomfort, a burning sensation, weakness, gait disturbance, loss of balance, orthostatic hypotension, syncope, or neuropathic pain.'}, {'measure': 'Stage 2: Overall Survival (OS)', 'timeFrame': 'From randomization to death (Up to approximately 34 months)', 'description': 'OS was defined as the time from randomization to the death from any cause during the study. Participants who were not reported as having died at the time of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization. Kaplan-Meier (KM) method was used to estimate median OS for each treatment arm.'}], 'secondaryOutcomes': [{'measure': 'Stage 1 and Stage 2: Progression-free Survival (PFS)', 'timeFrame': 'From randomization to first occurrence of PD or death (Up to approximately 34 months)', 'description': 'PFS=time from randomization to the first occurrence of disease progression (PD) (based on either: PET-CT data/not including any PET data), as determined by investigator, per Lugano response criteria or death due to any cause, whichever occurs first. PD based on PET-CT data=score 4 (uptake moderately \\> liver) or 5 (uptake markedly higher than liver \\&/or new lesions) on 5-point scale (5PS) with an increase in intensity of uptake from baseline at individual target nodes/nodal masses and/or new FDG-avid foci extranodal lesions consistent with lymphoma at interim or end-of-treatment assessment. New lesions: New FDG-avid foci consistent with lymphoma rather than another etiology, Bone marrow: New/recurrent FDG-avid foci. Participants who did not report PD nor died at time of analysis were censored on the date of last evaluable tumor assessment if post-baseline tumor assessment or on date of randomization if no post-baseline tumor assessment. KM methodology was used to estimate median PFS.'}, {'measure': 'Stage 2: Complete Response Rate (CRR), as Determined by an Independent Review Committee (IRC) at the End of Treatment', 'timeFrame': 'Up to approximately 8.5 months', 'description': "CRR was defined as the percentage of participants who had a complete metabolic response (CMR) based on positron emission tomography-computed tomography (PET-CT) according to Lugano response criteria at the end of treatment as determined by IRC. CMR was defined as score 1, 2, or 3 (1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \\>mediastinum but ≤ liver) with or without a residual mass on 5PS at lymph nodes and extra lymphatic sites. In Waldeyer's ring or extranodal sites with high physiologic uptake or with activation within spleen or marrow (e.g., with chemotherapy/myeloid colony-stimulating factors), uptake may be greater than normal mediastinum and/or liver. In this circumstance, CMR was inferred if uptake at sites of initial involvement was no greater than surrounding normal tissue even if the tissue had high physiologic uptake; no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Percentages are rounded off."}, {'measure': 'Stage 2: Objective Response Rate (ORR) as Determined by an IRC at End of Treatment', 'timeFrame': 'Up to approximately 8.5 months', 'description': "ORR=percentage of participants with CMR/partial metabolic responses (PMR), based on PET-CT per Lugano response criteria as per an IRC. CMR=score 1, 2, or 3 with/ without a residual mass on 5PS at lymph nodes (LN) \\& extra lymphatic sites. In Waldeyer's ring or extra nodal sites with high physiologic uptake or with activation within spleen/marrow, uptake may be greater than normal mediastinum \\&/or liver. In this case, CMR was inferred if uptake at sites of initial involvement was no greater than surrounding normal tissue even if the tissue had high physiologic uptake; no new lesions \\& no evidence of FDG-avid disease in bone marrow. PMR=score 4 or 5 on 5PS (4=uptake moderately \\> liver; 5=uptake markedly higher than liver \\&/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size at LN \\& extra lymphatic sites; no new lesions \\& residual uptake higher than uptake in normal marrow but reduced compared with baseline. Percentages are rounded off."}, {'measure': 'Stage 1 and Stage 2: Percentage of Participants With Best Overall Response (BOR) as Determined by the Investigator', 'timeFrame': 'Up to approximately 34 months', 'description': 'BOR was defined as the best response while on study (based on PET-CT or CT data) according to Lugano response criteria, as determined by the investigator. CMR and PMR based on PET-CT data were defined as outlined in the ORR outcome measure (OM) number 8. CT-based complete radiologic response was defined as target lymphatic nodes/nodal masses regression to ≤ 1.5 centimeters (cm) in longest transverse diameter of a lesion (LDi); no extralymphatic sites of disease; absence of non-measured lesion; enlarged organs regress to normal; no new lesions and bone marrow normal by morphology, if indeterminate, immunohistochemistry (IHC) negative. CT-based partial response was defined as ≥50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of up to 6 target measurable nodes and extra nodal sites; absent/normal, regressed, but no increase in non-measured lesions; spleen regressed by \\>50% in length beyond normal and no new lesions. Percentages are rounded off.'}, {'measure': 'Stage 1 and Stage 2: CRR as Determined by the Investigator at End of Treatment', 'timeFrame': 'Stage 1: Up to approximately 6.2 months and Stage 2: Up to approximately 8.5 months', 'description': "CRR was defined as the percentage of participants who had CMR based positron emission tomography-computed tomography (PET-CT) according to Lugano response criteria at the end of treatment as determined by investigator. CMR was defined as score 1, 2, or 3 (1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \\>mediastinum but ≤ liver) with or without a residual mass on 5PS at lymph nodes and extra lymphatic sites. In Waldeyer's ring or extranodal sites with high physiologic uptake or with activation within spleen or marrow (e.g., with chemotherapy/myeloid colony-stimulating factors), uptake may be greater than normal mediastinum and/or liver. In this circumstance, CMR was inferred if uptake at sites of initial involvement is no greater than surrounding normal tissue even if the tissue has high physiologic uptake; no new lesions and no evidence of FDG-avid disease in bone marrow. Percentages are rounded off."}, {'measure': 'Stage 1 and Stage 2: ORR as Determined by the Investigator at End of Treatment', 'timeFrame': 'Stage 1: Up to approximately 6.2 months and Stage 2: Up to approximately 8.5 months', 'description': "ORR=percentage of participants with CMR/PMR, based on PET-CT as determined by investigator per Lugano response criteria. CMR=score 1, 2, or 3 with/ without a residual mass on 5PS at LN \\& extra lymphatic sites. In Waldeyer's ring or extra nodal sites with high physiologic uptake or with activation within spleen/marrow, uptake may be greater than normal mediastinum \\&/or liver. In this case, CMR was inferred if uptake at sites of initial involvement was no greater than surrounding normal tissue even if the tissue had high physiologic uptake; no new lesions \\& no evidence of FDG-avid disease in bone marrow. PMR=score 4 or 5 on 5PS (4=uptake moderately \\> liver; 5=uptake markedly higher than liver \\&/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size at LN \\& extra lymphatic sites; no new lesions \\& residual uptake higher than uptake in normal marrow but reduced compared with baseline. Percentages are rounded off."}, {'measure': 'Stage 2: Duration of Response (DOR)', 'timeFrame': 'Up to approximately 34 months', 'description': 'DOR=time from the date of the first occurrence of a documented objective response (complete or partial response \\[CR/PR\\]) (based on PET-CT or CT data) as determined by the investigator, using Lugano response criteria, until PD (based on either response: including PET-CT data or not including any PET data) or death, whichever occurred first. CMR and PMR based on PET-CT data were defined as outlined in the ORR OM. CT-based complete and partial response were defined as outlined in the BOR OM. PD defined as outlined in the PFS OM.'}, {'measure': 'Stage 1 and Stage 2: Event-free Survival (EFSeff)', 'timeFrame': 'Up to approximately 34 months', 'description': 'EFSeff was defined as the time from randomization to first to the earliest occurrence of the following: PD or relapse using Lugano response criteria (based on either response: including PET-CT data or not including any PET data); death due to any cause or initiation of any NALT. PD based on PET-CT data was defined as score 4 or 5 on 5PS with an increase in intensity of uptake from baseline at individual target nodes/nodal masses and/or new FDG-avid foci extranodal lesions consistent with lymphoma at interim or end-of-treatment assessment. New lesions: New FDG-avid foci consistent with lymphoma rather than another etiology, Bone marrow: New or recurrent FDG-avid foci. Participants with no EFSeff events were censored at the time of the last evaluable tumor assessment if post-baseline assessments were available and participants who did not undergo a post-baseline tumor assessment were censored at the time of randomization. KM method was used to estimate median EFS for each treatment arm.'}, {'measure': 'Stage 2: Time to Deterioration in Physical Functioning as Measured by the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire, Core 30 (EORTC QLQ-C30)', 'timeFrame': 'Up to approximately 34 months', 'description': 'Time to deterioration was defined as the time from randomization to the first documentation of a 10-point decrease in EORTC QLQ-C30 physical functioning scale. EORTC QLQ-C30 consists of 30 questions assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health status and quality of life (GHS/QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The functioning items were scored on a 4-point scale that ranged from "not at all" to "very much". Raw average scale scores were linearly transformed to range 0-100 with higher scores indicating higher response levels (i.e. higher functioning). KM method was used to estimate median time to deterioration for each treatment arm.'}, {'measure': 'Stage 2: Time to Deterioration in Fatigue Scale as Measured by the EORTC QLQ-C30', 'timeFrame': 'Up to approximately 34 months', 'description': 'Time to deterioration was defined as the time from randomization to the first documentation of a 10-point increase from baseline in EORTC QLQ-C30 fatigue scale. EORTC QLQ-C30 consists of 30 questions assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), GHS/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The symptom scale (fatigue) was scored on a 4-point scale that ranged from "not at all" to "very much". Raw average scale scores were linearly transformed to range 0-100 with higher scores indicating higher response levels (i.e. higher symptom severity). KM method was used to estimate median time to deterioration for each treatment arm.'}, {'measure': 'Stage 2: Time to Deterioration in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Lymphoma Subscale (FACT-Lym LymS)', 'timeFrame': 'Up to approximately 34 months', 'description': 'Time to deterioration was defined as the time from randomization to the first documentation of a \\>3-point decrease from baseline in FACT-Lym LymS. The FACT-Lym subscale has 4 domains: physical well-being, social/family well-being, emotional well-being, functional well-being and lymphoma-specific subscale (LymS). The FACT-Lym LYMS consists of common lymphoma disease and/or treatment-related symptoms (e.g., pain, fever, swelling, night sweats, insomnia, itching, weight loss, fatigue, and loss of appetite). FACT-Lym LYMS contains 15 items scored from 0-4, where 0="Not at all" and 4="very much". Scale score range is from 0 to 60. Higher score indicates better quality of life. KM method was used to estimate the median time to deterioration for each treatment arm.'}, {'measure': 'Stage 2: Change From Baseline in Physical Functioning as Measured by EORTC QLQ-C30', 'timeFrame': 'Baseline, Day 1 of Cycle 2, 3, 5 and 7 (Cycle length= 21 days), end of treatment, long-term follow-up visits every two months (up to approximately 34 months)', 'description': 'EORTC QLQ-C30 consists of 30 questions assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), GHS/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The functioning items were scored on a 4-point scale that ranged from "not at all" to "very much". Raw average scale scores were linearly transformed to range 0-100 with higher scores indicating higher response levels (i.e. higher physical functioning).'}, {'measure': 'Stage 2: Change From Baseline in Fatigue Scale as Measured by EORTC QLQ-C30', 'timeFrame': 'Baseline, Day 1 of Cycles 2, 3, 5 and 7 (Cycle length= 21 days), end of treatment, long-term follow-up visits every two months (up to approximately 34 months)', 'description': 'EORTC QLQ-C30 consists of 30 questions assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), GHS/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The symptom scale (fatigue) were scored on a 4-point scale that ranged from "not at all" to "very much". Raw average scale scores were linearly transformed to range 0-100 with higher scores indicating higher response levels (i.e. higher symptom severity). A positive change from baseline indicates an improvement.'}, {'measure': 'Stage 2: Change From Baseline in FACT-Lym LYMS Scores', 'timeFrame': 'Baseline, Day 1 of Cycle 2, 3, 5 and 7 (Cycle length= 21 days), end of treatment, long-term follow-up visits every two months (up to approximately 34 months)', 'description': 'The FACT-Lym subscale has 4 domains: physical well-being, social/family well-being, emotional well-being, functional well-being and lymphoma-specific subscale (LymS). The FACT-Lym LYMS consists of common lymphoma disease and/or treatment-related symptoms (e.g., pain, fever, swelling, night sweats, insomnia, itching, weight loss, fatigue, and loss of appetite). FACT-Lym LYMS contains 15 items scored from 0-4, where 0="Not at all" and 4="very much". Scale score range is from 0 to 60. Higher score indicates better quality of life. A positive change from baseline indicates an improvement.'}, {'measure': 'Stage 2: Change From Baseline in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity 12-Item (FACT/GOG-NTX-12) Scores', 'timeFrame': 'Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7 and 8 (Cycle length= 21 days), end of treatment, long-term follow-up visits every two months (up to approximately 34 months)', 'description': 'The FACT/GOG-NTX scale provides a targeted assessment of symptoms of peripheral neuropathy, including sensory, motor, and auditory problems and cold sensitivity. It contains 12 items scored from 0-4, where 0="Not at all" and 4="very much". Scores are summed for a range of 12-44, with lower scores indicating more severe neurotoxicity. Participants completed assessments until progression or non-protocol-specified anti-lymphoma treatment (NALT). Only records on or before the first NALT were summarized.'}, {'measure': 'Stage 2: Percentage of Participants With Clinically Meaningful Improvement in EORTC QLQ-C30 Physical Functioning Scale', 'timeFrame': 'Up to approximately 34 months', 'description': 'EORTC QLQ-C30 consists of 30 questions assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), GHS/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The functioning items were scored on a 4-point scale that ranged from "not at all" to "very much". Raw average scale scores were linearly transformed to range 0-100 with higher scores indicating higher response levels (i.e. higher functioning). Clinically meaningful improvement was defined as a participant with at least a 7 point scale score increase.'}, {'measure': 'Stage 2: Percentage of Participants With Clinically Meaningful Improvement in EORTC QLQ-C30 Fatigue Scale', 'timeFrame': 'Up to approximately 34 months', 'description': 'EORTC QLQ-C30 consists of 30 questions assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), GHS/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The symptom items were scored on a 4-point scale that ranged from "not at all" to "very much". Raw average scale scores were linearly transformed to range 0-100 with higher scores indicating higher response levels (i.e. higher symptom severity). Clinically meaningful improvement was defined as a participant with at least a 9 point scale score decrease.'}, {'measure': 'Stage 2: Percentage of Participants With Clinically Meaningful Improvement in FACT-Lym LYMS', 'timeFrame': 'Up to approximately 34 months', 'description': 'The FACT-Lym subscale has 4 domains: physical well-being, social/family well-being, emotional well-being, functional well-being and lymphoma-specific subscale (LymS). The FACT-Lym LYMS consists of common lymphoma disease and/or treatment-related symptoms (e.g., pain, fever, swelling, night sweats, insomnia, itching, weight loss, fatigue, and loss of appetite). FACT-Lym LYMS contains 15 items scored from 0-4, where 0="Not at all" and 4="very much". Scale score range is from 0 to 60. Higher score indicates better quality of life. Clinically meaningful improvement was defined as a 3-point increase from baseline.'}, {'measure': 'Stage 2: Number of Participants With AEs', 'timeFrame': 'From treatment initiation until 90 days after the last dose of study drug or initiation of NALT (approximately 10.6 months)', 'description': 'An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.'}, {'measure': 'Stage 2: Number of Participants With PN', 'timeFrame': 'From treatment initiation until 90 days after the last dose of study drug or initiation of NALT (approximately 10.6 months)', 'description': 'An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Participants receiving polatuzumab vedotin may develop PN, including peripheral sensory and/or motor neuropathy. Symptoms included hypoesthesia, hyperesthesia, paresthesia, dysesthesia, discomfort, a burning sensation, weakness, gait disturbance, loss of balance, orthostatic hypotension, syncope, or neuropathic pain.'}, {'measure': 'Stage 1 and Stage 2: Number of Participants With Dose Modification for Polatuzumab Vedotin', 'timeFrame': 'Stage 1: Up to approximately 5.3 months and Stage 2: Up to approximately 7.6 months', 'description': "Dose modifications (interruptions/reductions) were based on physical examination findings, observed toxicities, and laboratory results obtained within 72 hours before study treatment administration. The determination of all dose modifications was made based on the investigator's assessment of ongoing clinical benefit with continuing study treatment. Dosing occurred only when a participant's clinical assessment and laboratory test values were acceptable."}, {'measure': 'Stage 1 and Stage 2: Dose Intensity of Polatuzumab Vedotin', 'timeFrame': 'Stage 1: Up to approximately 5.3 months and Stage 2: Up to approximately 7.6 months', 'description': 'Dose intensity = (total dose actually received divided by the expected total dose)\\*100. Expected total dose for dose intensity accounting for delay/reduction is based on the expected number of cycles between the first and last exposure of each drug. Percentage of dose intensity accounting for delay/reduction in dose by the participants in each arm is reported here.'}, {'measure': 'Stage 1: OS', 'timeFrame': 'From randomization to the death (up to approximately 34 months)', 'description': 'OS was defined as the time from randomization to the death from any cause during the study. Participants who were not reported as having died at the time of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization. KM method was used to estimate median OS for each treatment arm.'}, {'measure': 'Stage 1 and Stage 2: Percentage of Participants With Anti-drug Antibodies (ADAs) to Polatuzumab Vedotin', 'timeFrame': 'Up to approximately 34 months', 'description': 'Treatment emergent ADA-positive participants after drug administration were determined for participants exposed to polatuzumab vedotin. Participants positive for treatment emergent ADA were defined as the number of post-baseline evaluable participants determined to have treatment-induced ADA or treatment-enhanced ADA during the study period. Treatment-induced ADA = a participant with negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 t.u. greater than the baseline titer result. Percentages are rounded off.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lymphoma', 'Large B-Cell', 'Diffuse'], 'conditions': ['Diffuse Large B-Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) in participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study comprises of two stages: a safety run-in stage and a randomized controlled trial (RCT).', 'detailedDescription': 'The safety run-in stage (Stage 1) will assess the safety of polatuzumab vedotin plus rituximab, gemcitabine and oxaliplatin (Pola-R-GemOx) in 10 participants. The randomized controlled trial (RCT) (Stage 2) will compare Pola-R-GemOx versus R-GemOx alone using overall survival (OS). This is an event-driven trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically-confirmed diffuse large B-cell lymphoma, not otherwise specified (NOS) or history of transformation of indolent disease to DLBCL\n* Relapsed disease (disease that has recurred following a response that lasted ≥ 6 months from completion of the last line of therapy) or refractory disease (disease that did not respond to or that progressed during therapy or progressed within 6 months (\\< 6 months) of prior therapy)\n* At least one (≥ 1) line of prior systemic therapy:\n* Patients may have undergone autologous hematopoietic stem cell transplantation (HSCT) prior to recruitment; In such cases, salvage chemotherapy (e.g., rituximab, dexamethasone, cytarabine, and cisplatin \\[R-DHAP\\] and rituximab, ifosfamide, carboplatin, and etoposide phosphate \\[R-ICE\\]) will be counted as one line of therapy and conditioning chemotherapy (e.g., BEAM) followed by consolidative autologous HSCT will be counted as one line of therapy\n* Patients may have undergone allogeneic HSCT prior to recruitment, so long as they are off all immunosuppressive therapy and have no active GVHD; In such cases, salvage chemotherapy (e.g., R-DHAP and R-ICE) will be counted as one line of therapy and conditioning chemotherapy (e.g., carmustine, etoposide, cytarabine, and melphalan \\[BEAM\\]) followed by allogeneic HSCT will be counted as a separate line of therapy\n* Participants may have undergone CAR T-cell therapy prior to recruitment. In such cases, cell collection, conditioning chemotherapy, and infusion will be counted as one line of therapy.\n* Local therapies (e.g., radiotherapy) will not be considered as lines of treatment\n* For participants with a history of the transformation of indolent disease to DLBCL, it is preferred that participants have received at least one treatment for the transformed lymphoma. However, if there are cases where the participants have received an anthracycline-containing chemotherapy regimen (such as R-CHOP) for the indolent lymphoma only, then these participants can be considered as eligible.\n* At least one bi-dimensionally measurable lesion, defined as \\> 1.5 cm in its longest dimension as measured by CT or MRI\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2\n* Adequate hematological function\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm,\n\nExclusion Criteria:\n\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products\n* Contraindication to rituximab, gemcitabine or oxaliplatin\n* Peripheral neuropathy assessed to be \\> Grade 1 according to NCI CTCAE v5.0\n* Prior use of polatuzumab vedotin or a gemcitabine plus platinum-based agent combination, recent participation in a clinical trial, and/or treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy within 2 weeks\n* Planned autologous or allogenic stem cell transplantation or CAR T-cell therapy at time of recruitment\n* Primary or secondary central nervous system (CNS) lymphoma\n* Richter's transformation or prior CLL\n* Abnormal laboratory values or health conditions, as assessed by the investigator, any known conditions preventing adherence to protocol or active bacterial, viral, fungal, mycobacterial, parasitic, or other infection\n* Vaccination with a live vaccine within 4 weeks prior to treatment\n* Recent major surgery (within 6 weeks before the start of Cycle 1 Day 1) other than for diagnosis\n* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications\n* Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 months after the last dose of study drug\n* Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study drug"}, 'identificationModule': {'nctId': 'NCT04182204', 'acronym': 'POLARGO', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase III, Open-Label, Multicenter, Randomized, Study Evaluating the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab Plus Gemcitabine Plus Oxaliplatin (R-GEMOX) Versus R-GEMOX Alone in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma', 'orgStudyIdInfo': {'id': 'MO40598'}, 'secondaryIdInfos': [{'id': '2018-003727-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pola-R-GemOx (Stage 1)', 'description': 'Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) for a maximum dose of 240 mg per cycle (mg/cycle) administered intravenously (IV) and rituximab 375 milligrams per square meter (mg/m\\^2) administered IV on Day 1. Participants will receive gemcitabine 1000 mg/m\\^2 administered IV and oxaliplatin 100 mg/m\\^2 administered IV on Day 2. Each cycle will consist of 21 days with up to 8 cycles of treatment administration.', 'interventionNames': ['Drug: Polatuzumab Vedotin', 'Drug: Rituximab', 'Drug: Gemcitabine', 'Drug: Oxaliplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Pola-R-GemOx (Stage 2)', 'description': 'Participants will receive polatuzumab vedotin 1.8 mg/kg for a maximum dose of 240 mg/cycle administered IV and rituximab 375 mg/m\\^2 administered IV on Day 1. Participants will receive gemcitabine 1000 mg/m\\^2 administered IV and oxaliplatin 100 mg/m\\^2 administered IV on Day 2. Each cycle will consist of 21 days with up to 8 cycles of treatment administration.', 'interventionNames': ['Drug: Polatuzumab Vedotin', 'Drug: Rituximab', 'Drug: Gemcitabine', 'Drug: Oxaliplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'R-GemOx (Stage 2)', 'description': 'Participants will receive rituximab 375 mg/m\\^2 administered IV on Day 1. Participants will receive gemcitabine 1000 mg/m\\^2 administered IV and oxaliplatin 100 mg/m\\^2 administered IV on Day 2. Each cycle will consist of 21 days with up to 8 cycles of treatment administration.', 'interventionNames': ['Drug: Rituximab', 'Drug: Gemcitabine', 'Drug: Oxaliplatin']}], 'interventions': [{'name': 'Polatuzumab Vedotin', 'type': 'DRUG', 'description': 'Polatuzumab vedotin 1.8 mg/kg for a maximum dose of 240 mg/cycle IV on Day 1 of each 21-day cycle for up to 8 cycles.', 'armGroupLabels': ['Pola-R-GemOx (Stage 1)', 'Pola-R-GemOx (Stage 2)']}, {'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['Mabthera; Rituxan'], 'description': 'Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle for up to 8 cycles.', 'armGroupLabels': ['Pola-R-GemOx (Stage 1)', 'Pola-R-GemOx (Stage 2)', 'R-GemOx (Stage 2)']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Gemcitabine 1000 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycles.', 'armGroupLabels': ['Pola-R-GemOx (Stage 1)', 'Pola-R-GemOx (Stage 2)', 'R-GemOx (Stage 2)']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'Oxaliplatin 100 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycle.', 'armGroupLabels': ['Pola-R-GemOx (Stage 1)', 'Pola-R-GemOx (Stage 2)', 'R-GemOx (Stage 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Cancer Specialists', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33028', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Memorial Cancer Institute at Memorial West', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'IHA Hematology Oncology Consultants - Ann Arbor', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'country': 'United States', 'facility': 'MSKCC at Basking Ridge', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center at Bergen', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11553', 'city': 'Uniondale', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Nassau', 'geoPoint': {'lat': 40.70038, 'lon': -73.59291}}, {'zip': '41253-190', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Hospital Sao Rafael - HSR', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'zip': '59040150', 'city': 'Natal', 'state': 'Rio Grande do Norte', 'country': 'Brazil', 'facility': 'Liga Norte Riograndense Contra O Câncer', 'geoPoint': {'lat': -5.795, 'lon': -35.20944}}, {'zip': 'DUMMY_VALUE', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital das Clinicas - 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