Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-30 @ 7:05 PM
Study NCT ID:
NCT02257567
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2014-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'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': 'D000069461', 'term': 'Bendamustine Hydrochloride'}, {'id': 'C543332', 'term': 'obinutuzumab'}, {'id': 'C000600736', 'term': 'polatuzumab vedotin'}, {'id': 'D005440', 'term': 'Fluid Therapy'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Baseline up to study completion/discontinuation (up to approximately 84 months)', 'description': 'All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 2, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 2, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 4, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 39, 'otherNumAffected': 38, 'seriousNumAtRisk': 38, 'deathsNumAffected': 16, 'seriousNumAffected': 25}, {'id': 'EG005', 'title': 'Arm B (Phase II Randomization): BR in FL', 'description': 'Participants with FL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 39, 'seriousNumAtRisk': 41, 'deathsNumAffected': 11, 'seriousNumAffected': 12}, {'id': 'EG006', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 40, 'otherNumAffected': 36, 'seriousNumAtRisk': 39, 'deathsNumAffected': 26, 'seriousNumAffected': 24}, {'id': 'EG007', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 40, 'otherNumAffected': 37, 'seriousNumAtRisk': 39, 'deathsNumAffected': 30, 'seriousNumAffected': 27}, {'id': 'EG008', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'deathsNumAffected': 3, 'seriousNumAffected': 8}, {'id': 'EG009', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 21, 'otherNumAffected': 19, 'seriousNumAtRisk': 20, 'deathsNumAffected': 18, 'seriousNumAffected': 13}, {'id': 'EG010', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 103, 'seriousNumAtRisk': 106, 'deathsNumAffected': 65, 'seriousNumAffected': 57}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 24, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 41, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 39, 'numEvents': 28, 'numAffected': 19}, {'groupId': 'EG008', 'numAtRisk': 20, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG010', 'numAtRisk': 106, 'numEvents': 35, 'numAffected': 27}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 39, 'numEvents': 19, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 106, 'numEvents': 17, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'LYMPHOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 106, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 31, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 41, 'numEvents': 18, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 27, 'numAffected': 14}, {'groupId': 'EG007', 'numAtRisk': 39, 'numEvents': 63, 'numAffected': 21}, {'groupId': 'EG008', 'numAtRisk': 20, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 20, 'numEvents': 30, 'numAffected': 6}, {'groupId': 'EG010', 'numAtRisk': 106, 'numEvents': 73, 'numAffected': 35}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'PANCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 41, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 18, 'numAffected': 11}, {'groupId': 'EG007', 'numAtRisk': 39, 'numEvents': 50, 'numAffected': 19}, {'groupId': 'EG008', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 20, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG010', 'numAtRisk': 106, 'numEvents': 40, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 106, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'HYPOACUSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'ABDOMINAL DISTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 41, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 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'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase Ib: Percentage of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG002', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG003', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the study start up to the end of the study (up to approximately 84 months)', 'description': 'An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 4.0 (NCI-CTCAE, v4.0).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all ITT participants from Phase Ib who received at least one dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Arm G+H (Phase II NF Cohort): Percentage of Participants With AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Month 37 to Month 84 (up to approximately 47 months)', 'description': 'An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the NCI-CTCAE, v4.0. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all ITT participants from Arms G+H (Phase II NF Cohort) who received at least one dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Cohort 1a (Phase Ib): Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Polatuzumab Vedotin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'title': 'Baseline Prevalence of ADAs', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Post-Baseline Incidence of ADAs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to approximately Month 24', 'description': 'The number of participants with positive results for ADA against pola at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = 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 titer unit (t.u.) greater than the baseline titer result. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all ITT participants from Cohort 1a (Phase Ib) who received at least one dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Cohort 1b (Phase Ib): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG001', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'title': 'Baseline Prevalence of ADAs to Polatuzumab vedotin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post-Baseline Incidence of ADAs to Polatuzumab vedotin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Prevalence of ADAs to Obinutuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post-Baseline Incidence of ADA to Obinutuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to approximately Month 24', 'description': 'The number of participants with positive results for ADA against pola and obinutuzumab at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = 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. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population consisted of all ITT participants from Cohort 1b (Phase Ib) who received at least one dose of study medication. 'Number Analyzed' is the number of participants with data available for analysis at the specified time point."}, {'type': 'PRIMARY', 'title': 'Arms G+H: (Phase II NF Cohorts): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin (Lyophilized)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Arm H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'title': 'Baseline Prevalence of ADAs to Polatuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Post-Baseline Incidence of ADAs to Polatuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Month 37 to Month 84 (up to approximately 47 months)', 'description': 'The number of participants with positive results for ADA against lyophilized pola at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = 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. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population consisted of all ITT participants from Arm G+H (Phase II NF cohort) who received at least one dose of study medication. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint."}, {'type': 'PRIMARY', 'title': 'Phase II Randomized and NF Cohorts: Percentage of Participants With Complete Response (CR) at Primary Response Assessment (PRA) Based on Positron Emission Tomography (PET)-Computed Tomography (CT) Scan as Determined by Independent Review Committee (IRC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '106', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Arm B (Phase II Randomization): BR in FL', 'description': 'Participants with FL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG002', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG003', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG004', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000', 'lowerLimit': '52.43', 'upperLimit': '82.98'}, {'value': '63.4', 'groupId': 'OG001', 'lowerLimit': '46.94', 'upperLimit': '77.88'}, {'value': '42.5', 'groupId': 'OG002', 'lowerLimit': '27.04', 'upperLimit': '59.11'}, {'value': '17.5', 'groupId': 'OG003', 'lowerLimit': '7.34', 'upperLimit': '32.78'}, {'value': '39.6', 'groupId': 'OG004', 'lowerLimit': '30.25', 'upperLimit': '49.59'}]}]}], 'analyses': [{'pValue': '0.5353', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.82', 'ciLowerLimit': '-14.53', 'ciUpperLimit': '25.38', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0128', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Response Rates (4.89', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.00', 'ciLowerLimit': '4.89', 'ciUpperLimit': '42.63', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)', 'description': 'CR was assessed by IRC at PRA according to Modified Lugano Response Criteria (MLRC). Per MLRC, CR based on PET-CT was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites (ELS) with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS) where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \\> mediastinum but ≤ liver; 4=uptake moderately \\> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, immunohistochemistry (IHC) negative. As pre-specified in the protocol data reported is combined for Arms G and H. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Phase II Randomized and NF cohorts irrespective of whether or not they received the study treatment.'}, {'type': 'PRIMARY', 'title': 'Arm H (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on PET-CT as Determined by the IRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.2', 'groupId': 'OG000', 'lowerLimit': '29.94', 'upperLimit': '55.18'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6-8 weeks after Cycle 6, Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)', 'description': 'CR was assessed by IRC at PRA according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \\> mediastinum but ≤ liver; 4=uptake moderately \\> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Arm H (Phase II NF Cohort) irrespective of whether or not they received the study treatment.'}, {'type': 'PRIMARY', 'title': 'Arm G (Phase II NF Cohort): Area Under Concentration-Time Curve (AUC) of Polatuzumab Vedotin (Lyophilized)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'title': 'acMMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2880', 'spread': '0.15', 'groupId': 'OG000'}]}]}, {'title': 'Total Antibody (Ab)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'MMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.6', 'spread': '45', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (each cycle is 21 days DLBCL cohorts) up to approximately 9 weeks', 'description': 'Pharmacokinetic (PK) of three pola-related analytes: antibody conjugated monomethyl auristatin E (acMMAE), total antibody, and unconjugated MMAE were measured. The unit of measure for AUC is nanograms\\*day per milliliters.', 'unitOfMeasure': 'ng*day/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population included all ITT participants in Arm G (Phase II NF Cohort) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at the specified time point."}, {'type': 'PRIMARY', 'title': 'Arm G (Phase II NF Cohort): Maximum Concentration (Cmax) of Polatuzumab Vedotin (Lyophilized)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'title': 'acMMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '724', 'spread': '10', 'groupId': 'OG000'}]}]}, {'title': 'Total Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'MMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.01', 'spread': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4,(cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.', 'unitOfMeasure': 'nanograms per milliliters (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Arm G (Phase II NF Cohort) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at the specified time point."}, {'type': 'PRIMARY', 'title': 'Arm G (Phase II NF Cohort): Systemic Clearance (CL) of Polatuzumab Vedotin (Lyophilized)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'timeFrame': 'Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured. Unit of measure for CL is milliliters per day per kilograms (mL/day/kg)', 'reportingStatus': 'POSTED', 'populationDescription': "As pre-specified in the protocol the analysis of this outcome measure (OM) was based on sponsor's discretion however, sponsor opted to not collect data for this OM."}, {'type': 'PRIMARY', 'title': 'Arm G (Phase II NF Cohort): Steady-State Volume of Distribution (Vss) of Polatuzumab Vedotin (Lyophilized)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'timeFrame': 'Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, Day (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.', 'reportingStatus': 'POSTED', 'populationDescription': "As pre-specified in the protocol the analysis of this OM was based on sponsor's discretion however, sponsor opted to not collect data for this OM."}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants With AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '106', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Arm B (Phase II Randomization): BR in FL', 'description': 'Participants with FL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG002', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG003', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG004', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG005', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG006', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '97.4', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '100', 'groupId': 'OG005'}, {'value': '99.1', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the study start up to the end of the study (up to approximately 84 months)', 'description': 'An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the NCI-CTCAE, v4.0. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all ITT participants from Phase II who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Arms A and C (Phase II): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'title': 'Baseline Prevalence of ADAs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post-Baseline Incidence of ADAs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to approximately Month 24', 'description': 'The number of participants with positive results for ADA against pola at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = 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. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population consisted of all ITT participants from Arms A and C (Phase II) who received at least one dose of study medication. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint."}, {'type': 'SECONDARY', 'title': 'Arms E and F (Phase II): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG001', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'title': 'Baseline Prevalence of ADAs to Polatuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post-Baseline Incidence of ADAs to Polatuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}, {'value': '5.6', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Prevalence of ADAs to Obinutuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post-Baseline Incidence of ADAs to Obinutuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to approximately Month 24', 'description': 'The number of participants with positive results for ADA against pola and obinutuzumab at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = 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. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population consisted of all ITT participants from Arms E and F (Phase II) who received at least one dose of study medication. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint."}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants With CR at PRA Based on PET-CT as Determined by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '106', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Arm B (Phase II Randomization): BR in FL', 'description': 'Participants with FL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG002', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG003', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG004', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG005', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG006', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.1', 'groupId': 'OG000', 'lowerLimit': '47.18', 'upperLimit': '78.80'}, {'value': '63.4', 'groupId': 'OG001', 'lowerLimit': '46.94', 'upperLimit': '77.88'}, {'value': '42.5', 'groupId': 'OG002', 'lowerLimit': '27.04', 'upperLimit': '59.11'}, {'value': '15.0', 'groupId': 'OG003', 'lowerLimit': '5.71', 'upperLimit': '29.84'}, {'value': '65.0', 'groupId': 'OG004', 'lowerLimit': '40.78', 'upperLimit': '84.61'}, {'value': '33.3', 'groupId': 'OG005', 'lowerLimit': '14.59', 'upperLimit': '56.97'}, {'value': '36.8', 'groupId': 'OG006', 'lowerLimit': '27.63', 'upperLimit': '46.71'}]}]}], 'analyses': [{'pValue': '0.8817', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '-19.68', 'ciUpperLimit': '20.86', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0061', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.50', 'ciLowerLimit': '7.66', 'ciUpperLimit': '44.74', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)', 'description': 'CR was assessed by investigator at PRA according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \\> mediastinum but ≤ liver; 4=uptake moderately \\> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts) or after final dose of study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Phase II irrespective of whether or not they received the study treatment.'}, {'type': 'SECONDARY', 'title': 'Phase II Expansion Cohorts and Arm G (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on PET-CT as Determined by the IRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG001', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG002', 'title': 'Arm G (Phase II Expansion): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.0', 'groupId': 'OG000', 'lowerLimit': '40.78', 'upperLimit': '84.61'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '14.59', 'upperLimit': '56.97'}, {'value': '35.7', 'groupId': 'OG002', 'lowerLimit': '21.55', 'upperLimit': '51.97'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)', 'description': 'CR was assessed by IRC at PRA according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \\> mediastinum but ≤ liver; 4=uptake moderately \\> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Phase II Expansion Cohorts and Arm G (Phase II NF Cohort) irrespective of whether or not they received the study treatment.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants With Objective Response (OR) at PRA Based on PET-CT as Determined by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '106', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Arm B (Phase II Randomization): BR in FL', 'description': 'Participants with FL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG002', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG003', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG004', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG005', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG006', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.5', 'groupId': 'OG000', 'lowerLimit': '63.54', 'upperLimit': '90.70'}, {'value': '80.5', 'groupId': 'OG001', 'lowerLimit': '63.13', 'upperLimit': '91.18'}, {'value': '47.5', 'groupId': 'OG002', 'lowerLimit': '31.51', 'upperLimit': '63.87'}, {'value': '17.5', 'groupId': 'OG003', 'lowerLimit': '7.34', 'upperLimit': '32.78'}, {'value': '85.0', 'groupId': 'OG004', 'lowerLimit': '62.11', 'upperLimit': '96.79'}, {'value': '33.3', 'groupId': 'OG005', 'lowerLimit': '14.59', 'upperLimit': '56.97'}, {'value': '42.5', 'groupId': 'OG006', 'lowerLimit': '32.91', 'upperLimit': '52.43'}]}]}], 'analyses': [{'pValue': '0.9523', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.00', 'ciLowerLimit': '-18.66', 'ciUpperLimit': '16.46', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0036', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.00', 'ciLowerLimit': '9.48', 'ciUpperLimit': '47.37', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)', 'description': 'OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the investigator according to MLRC. Per MLRC, CR based on PET-CT complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass on 5PS, where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake mediastinum but ≤ liver; 4=uptake moderately \\> liver; 5=uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of FDG-avid disease in bone marrow, normal by morphology; if indeterminate, IHC negative. PR based on PET-CT was defined as partial MR in lymph nodes and ELS with a score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size at interim, residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Phase II irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants With OR at PRA Based on PET-CT as Determined by IRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '106', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Arm B (Phase II Randomization): BR in FL', 'description': 'Participants with FL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG002', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG003', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG004', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG005', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG006', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000', 'lowerLimit': '60.67', 'upperLimit': '88.87'}, {'value': '73.2', 'groupId': 'OG001', 'lowerLimit': '57.06', 'upperLimit': '85.78'}, {'value': '42.5', 'groupId': 'OG002', 'lowerLimit': '27.04', 'upperLimit': '59.11'}, {'value': '17.5', 'groupId': 'OG003', 'lowerLimit': '7.34', 'upperLimit': '32.78'}, {'value': '85.0', 'groupId': 'OG004', 'lowerLimit': '62.11', 'upperLimit': '96.79'}, {'value': '38.1', 'groupId': 'OG005', 'lowerLimit': '18.11', 'upperLimit': '61.56'}, {'value': '43.4', 'groupId': 'OG006', 'lowerLimit': '33.80', 'upperLimit': '53.37'}]}]}], 'analyses': [{'pValue': '0.6574', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.75', 'ciLowerLimit': '-15.14', 'ciUpperLimit': '22.11', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0128', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.00', 'ciLowerLimit': '4.89', 'ciUpperLimit': '42.63', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)', 'description': 'OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the IRC according to MLRC. Per MLRC, CR based on PET-CT= complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass on 5PS, where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake mediastinum but ≤ liver; 4=uptake moderately \\> liver; 5=uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of FDG-avid disease in bone marrow. Bone marrow normal by morphology; if indeterminate, IHC negative. PR based on PET-CT was defined as partial MR in lymph nodes and ELS with a score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size at interim, residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Phase II irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants With CR at PRA Based on CT Only as Determined by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '106', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Arm B (Phase II Randomization): BR in FL', 'description': 'Participants with FL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG002', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG003', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG004', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG005', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG006', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000', 'lowerLimit': '30.09', 'upperLimit': '62.82'}, {'value': '19.5', 'groupId': 'OG001', 'lowerLimit': '8.82', 'upperLimit': '34.87'}, {'value': '20.0', 'groupId': 'OG002', 'lowerLimit': '9.05', 'upperLimit': '35.65'}, {'value': '5.0', 'groupId': 'OG003', 'lowerLimit': '0.61', 'upperLimit': '16.92'}, {'value': '20.0', 'groupId': 'OG004', 'lowerLimit': '5.73', 'upperLimit': '43.66'}, {'value': '14.3', 'groupId': 'OG005', 'lowerLimit': '3.05', 'upperLimit': '36.34'}, {'value': '14.2', 'groupId': 'OG006', 'lowerLimit': '8.14', 'upperLimit': '22.26'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)', 'description': 'CR was determined by investigator at PRA according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 centimetres (cm) in in longest transverse diameter (LDi) and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts). As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Phase II irrespective of whether or not they received the study treatment.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants With CR at PRA Based on CT Only as Determined by IRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '106', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Arm B (Phase II Randomization): BR in FL', 'description': 'Participants with FL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG002', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG003', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG004', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG005', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG006', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000', 'lowerLimit': '25.57', 'upperLimit': '57.90'}, {'value': '36.6', 'groupId': 'OG001', 'lowerLimit': '22.12', 'upperLimit': '53.06'}, {'value': '22.5', 'groupId': 'OG002', 'lowerLimit': '10.84', 'upperLimit': '38.45'}, {'value': '2.5', 'groupId': 'OG003', 'lowerLimit': '0.06', 'upperLimit': '13.16'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '27.20', 'upperLimit': '72.80'}, {'value': '23.8', 'groupId': 'OG005', 'lowerLimit': '8.22', 'upperLimit': '47.17'}, {'value': '17.9', 'groupId': 'OG006', 'lowerLimit': '11.15', 'upperLimit': '26.57'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)', 'description': 'CR was determined by IRC a at PRA according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts). As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Phase II irrespective of whether or not they received the study treatment.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants With OR at PRA Based on CT Only as Determined by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '106', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Arm B (Phase II Randomization): BR in FL', 'description': 'Participants with FL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG002', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG003', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG004', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG005', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG006', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.5', 'groupId': 'OG000', 'lowerLimit': '63.54', 'upperLimit': '90.70'}, {'value': '75.6', 'groupId': 'OG001', 'lowerLimit': '59.70', 'upperLimit': '87.64'}, {'value': '45.0', 'groupId': 'OG002', 'lowerLimit': '29.26', 'upperLimit': '61.51'}, {'value': '15.0', 'groupId': 'OG003', 'lowerLimit': '5.71', 'upperLimit': '29.84'}, {'value': '80.0', 'groupId': 'OG004', 'lowerLimit': '56.34', 'upperLimit': '94.27'}, {'value': '33.3', 'groupId': 'OG005', 'lowerLimit': '14.59', 'upperLimit': '56.97'}, {'value': '42.5', 'groupId': 'OG006', 'lowerLimit': '32.91', 'upperLimit': '52.43'}]}]}], 'analyses': [{'pValue': '0.6225', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.88', 'ciLowerLimit': '-14.49', 'ciUpperLimit': '21.72', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0032', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.00', 'ciLowerLimit': '9.94', 'ciUpperLimit': '47.12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)', 'description': 'OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the investigator based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in sum of the products of greatest diameters (SPD) of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Phase II irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants With OR at PRA Based on CT Only as Determined by IRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '106', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Arm B (Phase II Randomization): BR in FL', 'description': 'Participants with FL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG002', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG003', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG004', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG005', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG006', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.4', 'groupId': 'OG000', 'lowerLimit': '57.87', 'upperLimit': '86.96'}, {'value': '80.5', 'groupId': 'OG001', 'lowerLimit': '65.13', 'upperLimit': '91.18'}, {'value': '40.0', 'groupId': 'OG002', 'lowerLimit': '24.86', 'upperLimit': '56.67'}, {'value': '15.0', 'groupId': 'OG003', 'lowerLimit': '5.71', 'upperLimit': '29.84'}, {'value': '80.0', 'groupId': 'OG004', 'lowerLimit': '56.34', 'upperLimit': '94.27'}, {'value': '38.1', 'groupId': 'OG005', 'lowerLimit': '18.11', 'upperLimit': '61.56'}, {'value': '41.5', 'groupId': 'OG006', 'lowerLimit': '32.02', 'upperLimit': '51.49'}]}]}], 'analyses': [{'pValue': '0.4835', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.13', 'ciLowerLimit': '-24.14', 'ciUpperLimit': '12.12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0096', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.00', 'ciLowerLimit': '5.39', 'ciUpperLimit': '42.33', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)', 'description': 'OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the IRC based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease SPD of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Phase II irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants With Best Objective Response (BOR) Based on PET-CT or CT Only as Determined by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '106', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Arm B (Phase II Randomization): BR in FL', 'description': 'Participants with FL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG002', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG003', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG004', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG005', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG006', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.7', 'groupId': 'OG000', 'lowerLimit': '75.78', 'upperLimit': '97.13'}, {'value': '90.2', 'groupId': 'OG001', 'lowerLimit': '76.87', 'upperLimit': '97.28'}, {'value': '70.0', 'groupId': 'OG002', 'lowerLimit': '53.47', 'upperLimit': '83.44'}, {'value': '32.5', 'groupId': 'OG003', 'lowerLimit': '18.57', 'upperLimit': '49.13'}, {'value': '90.0', 'groupId': 'OG004', 'lowerLimit': '68.30', 'upperLimit': '98.77'}, {'value': '52.4', 'groupId': 'OG005', 'lowerLimit': '29.78', 'upperLimit': '74.29'}, {'value': '62.3', 'groupId': 'OG006', 'lowerLimit': '52.33', 'upperLimit': '71.50'}]}]}], 'analyses': [{'pValue': '0.9390', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-15.07', 'ciUpperLimit': '13.71', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0006', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.50', 'ciLowerLimit': '15.64', 'ciUpperLimit': '54.71', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to every 6 months until disease progression, withdrawal or study completion (up to approximately 84 months)', 'description': 'BOR=CR/PR per PET-CT/CT per MLRC.CR per PET-CT=complete MR in LN \\& ELS, score=1, 2,3 with/without a residual mass on 5-PS; 1=no uptake(UT) above background;2=UT≤mediastinum;3=UT\\>mediastinum but ≤liver;4=UT moderately\\>liver;5=UT markedly higher than liver \\&/or new lesions;no evidence of FDG-avid disease, bone marrow morphology=normal;if indeterminate, is IHC negative.PR per PET-CT=partial MR in LN \\& ELS, score=4 or 5, reduced UT than baseline (BL) \\& residual mass of any size;residual UT\\>UT in normal marrow but reduced than BL.CR per CT=complete radiologic response with target nodes/nodal masses regressed to ≤1.5cm in LDi \\& no ELS of disease, absences of non-measured lesion;organ enlargement regressed to normal;no new lesions;bone marrow= normal;if indeterminate, is IHC negative.PR per CT=≥50% decrease in SPD of up to 6 target nodes \\& extranodal sites;non-measured lesions=absent/normal/regressed/no increase;spleen=regressed by ≥50% in length beyond normal, no new lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Phase II irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.'}, {'type': 'SECONDARY', 'title': 'DLBCL Cohorts: Percentage of Participants With BOR Based PET-CT or CT Only as Determined by IRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG002', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG003', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '45.80', 'upperLimit': '77.27'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '12.69', 'upperLimit': '41.20'}, {'value': '42.9', 'groupId': 'OG002', 'lowerLimit': '21.82', 'upperLimit': '65.98'}, {'value': '57.5', 'groupId': 'OG003', 'lowerLimit': '47.57', 'upperLimit': '67.09'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.50', 'ciLowerLimit': '15.82', 'ciUpperLimit': '54.62', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to every 6 months until disease progression, withdrawal or study completion (up to approximately 84 months)', 'description': 'BOR=CR/PR per PET-CT/CT per MLRC.CR per PET-CT=complete MR in LN \\& ELS, score=1, 2,3 with/without a residual mass on 5-PS; 1=no uptake(UT) above background;2=UT≤mediastinum;3=UT\\>mediastinum but ≤liver;4=UT moderately\\>liver;5=UT markedly higher than liver \\&/or new lesions;no evidence of FDG-avid disease, bone marrow morphology=normal;if indeterminate, is IHC negative.PR per PET-CT=partial MR in LN \\& ELS, score=4 or 5, reduced UT than baseline (BL) \\& residual mass of any size;residual UT\\>UT in normal marrow but reduced than BL.CR per CT=complete radiologic response with target nodes/nodal masses regressed to ≤1.5cm in LDi \\& no ELS of disease, absences of non-measured lesion;organ enlargement regressed to normal;no new lesions;bone marrow= normal;if indeterminate, is IHC negative.PR per CT=≥50% decrease in SPD of up to 6 target nodes \\& extranodal sites;non-measured lesions=absent/normal/regressed/no increase;spleen=regressed by ≥50% in length beyond normal, no new lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in DLBCL Cohorts irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.'}, {'type': 'SECONDARY', 'title': 'DLBCL Cohorts: Duration of Response (DOR) Based on PET-CT or CT Only as Determined by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG002', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG003', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.665', 'groupId': 'OG000', 'lowerLimit': '5.782', 'upperLimit': '27.926'}, {'value': '4.074', 'groupId': 'OG001', 'lowerLimit': '2.563', 'upperLimit': '12.682'}, {'value': '16.099', 'groupId': 'OG002', 'lowerLimit': '2.825', 'upperLimit': '27.860'}, {'value': '11.335', 'groupId': 'OG003', 'lowerLimit': '6.242', 'upperLimit': '16.197'}]}]}], 'analyses': [{'pValue': '0.0245', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.42', 'ciLowerLimit': '0.19', 'ciUpperLimit': '0.91', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse, or death from any cause whichever occur first (up to approximately 84 months)', 'description': 'DOR=first occurrence of CR/PR to disease progression/relapse/death per PET-CT/CT, per investigator per MLRC.CR per PET-CT=score 1/2/3 with/without a residual mass on 5-PS for LN and ELS;1=no UT\\> background; 2=UT≤mediastinum;3=UT\\>mediastinum but ≤liver;4=UT moderately\\>liver;5=UT\\>than liver \\&/or new lesions;bone marrow morphology=no evidence of FDG-avid disease, normal;if indeterminate IHC negative.PR per PET-CT=score of 4/5 with reduced UT compared to BL \\& residual mass of any size at interim for LN \\& ELS;residual UT\\>UT in normal bone marrow but\\<than BL. CR per CT=target nodes/nodal masses regressed to ≤1.5cm in LDi no ELS of disease for LN \\& ELS, no non-measured lesion, organ enlargement regressed to normal; bone marrow=normal morphology; if indeterminate, IHC negative. PR per CT= ≥50% decrease SPD of 6 target measurable LN and extranodal sites, absent/normal/regressed but no increase in non-measured lesions, spleen ≥50% in length beyond normal involvement, no new sites of lesions.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all randomized participants in DLBCL Cohorts irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. 'Overall Number Analyzed' are the number of participants with data available for analysis."}, {'type': 'SECONDARY', 'title': 'DLBCL Cohorts: DOR Based on PET-CT or CT Only as Determined by the IRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG002', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG003', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.908', 'groupId': 'OG000', 'lowerLimit': '5.684', 'upperLimit': '40.674'}, {'value': '10.645', 'groupId': 'OG001', 'lowerLimit': '3.975', 'upperLimit': '19.647'}, {'value': '25.758', 'groupId': 'OG002', 'lowerLimit': '9.692', 'upperLimit': '46.752'}, {'value': '13.437', 'groupId': 'OG003', 'lowerLimit': '8.641', 'upperLimit': '20.041'}]}]}], 'analyses': [{'pValue': '0.2451', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.25', 'ciUpperLimit': '1.43', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse, or death from any cause whichever occur first (up to approximately 84 months)', 'description': 'DOR=first occurrence of CR/PR to disease progression/relapse/death per PET-CT/CT, per IRC per MLRC.CR per PET-CT=score 1/2/3 with/without a residual mass on 5-PS for LN and ELS;1=no UT\\> background; 2=UT≤mediastinum;3=UT\\>mediastinum but ≤liver;4=UT moderately\\>liver;5=UT\\>than liver \\&/or new lesions;bone marrow morphology=no evidence of FDG-avid disease, normal;if indeterminate IHC negative.PR per PET-CT=score of 4/5 with reduced UT compared to BL \\& residual mass of any size at interim for LN \\& ELS;residual UT\\>UT in normal bone marrow but\\<than BL. CR per CT=target nodes/nodal masses regressed to ≤1.5cm in LDi no ELS of disease for LN \\& ELS, no non-measured lesion, organ enlargement regressed to normal; bone marrow=normal morphology; if indeterminate, IHC negative. PR per CT= ≥50% decrease SPD of 6 target measurable LN and extranodal sites, absent/normal/regressed but no increase in non-measured lesions, spleen ≥50% in length beyond normal involvement, no new sites of lesions.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all randomized participants in DLBCL Cohorts irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. 'Overall Number Analyzed' are the number of participants with data available for analysis."}, {'type': 'SECONDARY', 'title': 'DLBCL Cohorts: Progression Free Survival (PFS) Based on PET-CT or CT Only as Determined by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG002', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG003', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.491', 'groupId': 'OG000', 'lowerLimit': '4.928', 'upperLimit': '16.953'}, {'value': '2.037', 'groupId': 'OG001', 'lowerLimit': '1.544', 'upperLimit': '3.713'}, {'value': '5.125', 'groupId': 'OG002', 'lowerLimit': '2.103', 'upperLimit': '18.234'}, {'value': '5.881', 'groupId': 'OG003', 'lowerLimit': '4.764', 'upperLimit': '7.524'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '0.20', 'ciUpperLimit': '0.56', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (up to approximately 84 months)', 'description': 'PFS was defined as the time randomization or from first study treatment (for obinuzumab arms) to the first occurrence of disease progression, relapse or death, from any cause based on PET-CT or CT only, as determined by the investigators assessment. As pre-specified in the protocol data reported is combined for Arms G and H.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in DLBCL Cohorts irrespective of whether or not they received the study treatment.'}, {'type': 'SECONDARY', 'title': 'DLBCL Cohorts: PFS Based on PET-CT or CT Only as Determined by the IRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG002', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG003', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.248', 'groupId': 'OG000', 'lowerLimit': '6.045', 'upperLimit': '13.930'}, {'value': '3.713', 'groupId': 'OG001', 'lowerLimit': '2.070', 'upperLimit': '4.534'}, {'value': '5.848', 'groupId': 'OG002', 'lowerLimit': '2.103', 'upperLimit': '11.893'}, {'value': '6.965', 'groupId': 'OG003', 'lowerLimit': '5.092', 'upperLimit': '9.823'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '0.23', 'ciUpperLimit': '0.66', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (up to approximately 84 months)', 'description': 'PFS was defined as the time randomization or from first study treatment (for obinuzumab arms) to the first occurrence of disease progression, relapse or death, from any cause based on PET-CT or CT only, as determined by the IRC assessment. As pre-specified in the protocol data reported is combined for Arms G and H.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in DLBCL Cohorts irrespective of whether or not they received the study treatment.'}, {'type': 'SECONDARY', 'title': 'Phase II NF Cohort: Percentage of Participants With CR at PRA Based on PET-CT as Determined by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000', 'lowerLimit': '27.63', 'upperLimit': '46.71'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)', 'description': 'CR was assessed by Investigator at PRA according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \\> mediastinum but ≤ liver; 4=uptake moderately \\> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. As pre-specified in the protocol data reported is combined for Arms G and H. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment.'}, {'type': 'SECONDARY', 'title': 'Phase II NF Cohort: Percentage of Participants With OR at PRA Based on PET-CT as Determined by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.5', 'groupId': 'OG000', 'lowerLimit': '32.91', 'upperLimit': '52.43'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)', 'description': 'OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the investigator according to MLRC. Per MLRC, CR based on PET-CT= complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass on 5PS, where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake mediastinum but ≤ liver; 4=uptake moderately\\>liver; 5=uptake markedly higher than liver and/or new lesions ; no new lesions and no evidence of FDG-avid disease in bone marrow, normal by morphology; if indeterminate, IHC negative. PR based on PET-CT was defined as partial MR in lymph nodes and ELS with a score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size at interim, residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.'}, {'type': 'SECONDARY', 'title': 'Phase II NF Cohort: Percentage of Participants With OR at PRA Based on PET-CT as Determined by IRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.4', 'groupId': 'OG000', 'lowerLimit': '33.80', 'upperLimit': '53.37'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)', 'description': 'OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the IRC according to MLRC. Per MLRC, CR based on PET-CT= complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass on 5PS, where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake mediastinum but ≤ liver; 4=uptake moderately \\> liver; 5=uptake markedly higher than liver and/or new lesions ; no new lesions and no evidence of FDG-avid disease in bone marrow, bone marrow normal by morphology; if indeterminate, IHC negative. PR based on PET-CT was defined as partial MR in lymph nodes and ELS with a score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size at interim, residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.'}, {'type': 'SECONDARY', 'title': 'Phase II NF Cohorts: Percentage of Participants With BOR Based on PET-CT or CT Only as Determined by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'groupId': 'OG000', 'lowerLimit': '52.33', 'upperLimit': '71.50'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to every 6 months until disease progression, withdrawal or study completion (from Month 37 to Month 84 [up to approximately 47 months])', 'description': 'BOR=CR/PR per PET-CT/CT per MLRC. CR per PET-CT=complete MR in lymph nodes \\& ELS, score=1, 2,3 with/without a residual mass on 5-PS; 1=no UT above background; 2=UT≤mediastinum;3=UT\\>mediastinum but ≤liver;4=UT moderately\\>liver;5=UT markedly higher than liver \\&/or new lesions;no evidence of FDG-avid disease, bone marrow morphology=normal;if indeterminate, is IHC negative.PR per PET-CT=partial MR in lymph nodes \\& ELS, score=4 or 5, reduced UT than BL \\& residual mass of any size;residual UT\\>UT in normal marrow but reduced than BL.CR per CT=complete radiologic response with target nodes/nodal masses regressed to ≤1.5cm in LDi \\& no ELS of disease, absences of non-measured lesion;organ enlargement regressed to normal;no new lesions;bone marrow= normal;if indeterminate, is IHC negative.PR per CT=≥50% decrease in SPD of up to 6 target nodes \\& extranodal sites;non-measured lesions=absent/normal/regressed/no increase;spleen=regressed by ≥50% in length beyond normal, no new lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.'}, {'type': 'SECONDARY', 'title': 'Phase II NF Cohorts: Percentage of Participants With BOR Based on PET-CT or CT Only as Determined by the IRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.5', 'groupId': 'OG000', 'lowerLimit': '47.57', 'upperLimit': '67.09'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to every 6 months until disease progression, withdrawal or study completion (from Month 37 to Month 84 [up to approximately 47 months])', 'description': 'BOR=CR/PR per PET-CT/CT per MLRC. CR per PET-CT=complete MR in lymph nodes \\& ELS, score=1, 2,3 with/without a residual mass on 5-PS; 1=no UT above background; 2=UT≤mediastinum;3=UT\\>mediastinum but ≤liver;4=UT moderately\\>liver;5=UT markedly higher than liver \\&/or new lesions;no evidence of FDG-avid disease, bone marrow morphology=normal;if indeterminate, is IHC negative.PR per PET-CT=partial MR in lymph nodes \\& ELS, score=4 or 5, reduced UT than BL \\& residual mass of any size;residual UT\\>UT in normal marrow but reduced than BL.CR per CT=complete radiologic response with target nodes/nodal masses regressed to ≤1.5cm in LDi \\& no ELS of disease, absences of non-measured lesion;organ enlargement regressed to normal;no new lesions;bone marrow= normal;if indeterminate, is IHC negative.PR per CT=≥50% decrease in SPD of up to 6 target nodes \\& extranodal sites;non-measured lesions=absent/normal/regressed/no increase;spleen=regressed by ≥50% in length beyond normal, no new lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.'}, {'type': 'SECONDARY', 'title': 'Phase II NF Cohort: DOR Based on PET-CT or CT Only as Determined by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.335', 'groupId': 'OG000', 'lowerLimit': '6.242', 'upperLimit': '16.197'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse, or death from any cause whichever occur first (from Month 37 to Month 84 [up to approximately 47 months])', 'description': 'DOR=first occurrence of CR/PR to disease progression/relapse/death per PET-CT/CT, per investigator per MLRC.CR per PET-CT=score 1/2/3 with/without a residual mass on 5-PS for LN and ELS;1=no UT\\> background; 2=UT≤mediastinum;3=UT\\>mediastinum but ≤liver;4=UT moderately\\>liver;5=UT\\>than liver \\&/or new lesions;bone marrow morphology=no evidence of FDG-avid disease, normal;if indeterminate IHC negative.PR per PET-CT=score of 4/5 with reduced UT compared to BL \\& residual mass of any size at interim for LN \\& ELS;residual UT\\>UT in normal bone marrow but\\<than BL. CR per CT=target nodes/nodal masses regressed to ≤1.5cm in LDi no ELS of disease for LN \\& ELS, no non-measured lesion, organ enlargement regressed to normal; bone marrow=normal morphology; if indeterminate, IHC negative. PR per CT= ≥50% decrease SPD of 6 target measurable LN and extranodal sites, absent/normal/regressed but no increase in non-measured lesions, spleen ≥50% in length beyond normal involvement, no new sites of lesions.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. 'Overall Number Analyzed' are the number of participants with data available for analysis."}, {'type': 'SECONDARY', 'title': 'Phase II NF Cohort: DOR Based on PET-CT or CT Only as Determined by the IRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.437', 'groupId': 'OG000', 'lowerLimit': '8.641', 'upperLimit': '20.041'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse, or death from any cause whichever occur first (from Month 37 to Month 84 [up to approximately 47 months])', 'description': 'DOR=first occurrence of CR/PR to disease progression/relapse/death per PET-CT/CT, per IRC per MLRC.CR per PET-CT=score 1/2/3 with/without a residual mass on 5-PS for LN and ELS;1=no UT\\> background; 2=UT≤mediastinum;3=UT\\>mediastinum but ≤liver;4=UT moderately\\>liver;5=UT\\>than liver \\&/or new lesions;bone marrow morphology=no evidence of FDG-avid disease, normal;if indeterminate IHC negative.PR per PET-CT=score of 4/5 with reduced UT compared to BL \\& residual mass of any size at interim for LN \\& ELS;residual UT\\>UT in normal bone marrow but\\<than BL. CR per CT=target nodes/nodal masses regressed to ≤1.5cm in LDi no ELS of disease for LN \\& ELS, no non-measured lesion, organ enlargement regressed to normal; bone marrow=normal morphology; if indeterminate, IHC negative. PR per CT= ≥50% decrease SPD of 6 target measurable LN and extranodal sites, absent/normal/regressed but no increase in non-measured lesions, spleen ≥50% in length beyond normal involvement, no new sites of lesions.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. 'Overall Number Analyzed' are the number of participants with data available for analysis."}, {'type': 'SECONDARY', 'title': 'Phase II NF Cohort: PFS Based on PET-CT or CT Only as Determined by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.881', 'groupId': 'OG000', 'lowerLimit': '4.764', 'upperLimit': '7.524'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (from Month 37 to Month 84 [up to approximately 47 months])', 'description': 'PFS was defined as the time from randomization or from first study treatment (for obinuzumab arms) to the first occurrence of disease progression, relapse or death, from any cause based on PET-CT or CT only, as determined by the investigators assessment. As pre-specified in the protocol data reported is combined for Arms G and H.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment.'}, {'type': 'SECONDARY', 'title': 'Phase II NF Cohort: PFS Based on PET-CT or CT Only as Determined by the IRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.965', 'groupId': 'OG000', 'lowerLimit': '5.092', 'upperLimit': '9.823'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (from Month 37 to Month 84 [up to approximately 47 months])', 'description': 'PFS was defined as the time from randomization or from first study treatment (for obinuzumab arms) to the first occurrence of disease progression, relapse or death, from any cause based on PET-CT or CT only, as determined by the IRC assessment. As pre-specified in the protocol data reported is combined for Arms G and H.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment.'}, {'type': 'SECONDARY', 'title': 'Phase II NF Cohort: Event-Free Survival (EFS) Based on PET-CT or CT Only, as Determined by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.092', 'groupId': 'OG000', 'lowerLimit': '4.402', 'upperLimit': '6.867'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Month 37 to Month 84 (up to approximately 47 months)', 'description': 'EFS was defined as time from randomization to disease progression or relapse, as assessed by the investigator or death from any cause. As pre-specified in the protocol data reported is combined for Arms G and H.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment.'}, {'type': 'SECONDARY', 'title': 'Phase II NF Cohorts: Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.320', 'groupId': 'OG000', 'lowerLimit': '8.279', 'upperLimit': '16.986'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Month 37 to Month 84 (up to approximately 47 months)', 'description': 'OS was defined as the time from the date of randomization or first treatment (for obinutuzumab arms) to the date of death from any cause. As pre-specified in the protocol data reported is combined for Arms G and H.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment.'}, {'type': 'SECONDARY', 'title': 'Arm G (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on PET-CT as Determined by the IRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000', 'lowerLimit': '21.55', 'upperLimit': '51.97'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)', 'description': 'CR was assessed by IRC at PRA according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \\> mediastinum but ≤ liver; 4=uptake moderately \\> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. As pre-specified in the protocol data reported is combined for Arms G and H. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Arm G (Phase II NF Cohort) irrespective of whether or not they received the study treatment.'}, {'type': 'SECONDARY', 'title': 'Arm G (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on CT Only as Determined by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '2.66', 'upperLimit': '22.62'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)', 'description': 'CR was determined by Investigator at PRA according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts). Values have been rounded off to the nearest whole number.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Arm G (Phase II NF Cohort) irrespective of whether or not they received the study treatment.'}, {'type': 'SECONDARY', 'title': 'Arm G (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on CT Only as Determined by IRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '5.43', 'upperLimit': '28.54'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)', 'description': 'CR was determined by IRC at PRA according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts). Values have been rounded off to the nearest whole number.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Arm G (Phase II NF Cohort) irrespective of whether or not they received the study treatment.'}, {'type': 'SECONDARY', 'title': 'Arm G (Phase II NF Cohort): Percentage of Participants With OR at PRA Based on CT Only as Determined by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.1', 'groupId': 'OG000', 'lowerLimit': '23.57', 'upperLimit': '54.36'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to 23 weeks)', 'description': 'OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the investigator based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in SPD of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Arm G (Phase II NF Cohort) irrespective of whether or not they received the study treatment. Values have been rounded off to the nearest whole number.'}, {'type': 'SECONDARY', 'title': 'Arm G (Phase II NF Cohort): Percentage of Participants With OR at PRA Based on CT Only as Determined by IRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '19.57', 'upperLimit': '49.55'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to 23 weeks)', 'description': 'OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the IRC based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in SPD of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in Arm G (Phase II NF Cohort) irrespective of whether or not they received the study treatment. Values have been rounded off to the nearest whole number.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of of Polatuzumab Vedotin Analyte: acMMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG002', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG003', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG004', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG005', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG006', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG007', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'title': 'Cycle 1 Day 2: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were below lower limit of quantification (BLLQ).', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG007'}]}]}, {'title': 'Cycle 1 Day 2: 30 min Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '654', 'spread': '29.3', 'groupId': 'OG000'}, {'value': '617', 'spread': '26.2', 'groupId': 'OG001'}, {'value': '719', 'spread': '26.7', 'groupId': 'OG002'}, {'value': '718', 'spread': '14.2', 'groupId': 'OG003'}, {'value': '492', 'spread': '241.6', 'groupId': 'OG004'}, {'value': '643', 'spread': '24.7', 'groupId': 'OG005'}, {'value': '453', 'spread': '682.8', 'groupId': 'OG006'}, {'value': '472', 'spread': '617.2', 'groupId': 'OG007'}]}]}, {'title': 'Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '29.4', 'spread': '5887.2', 'groupId': 'OG000'}, {'value': '75.9', 'spread': '40.8', 'groupId': 'OG001'}, {'value': '90.7', 'spread': '46.1', 'groupId': 'OG002'}, {'value': '109', 'spread': '48.2', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '12.2', 'spread': '1626.9', 'groupId': 'OG000'}, {'value': '25.4', 'spread': '29.8', 'groupId': 'OG001'}, {'value': '28.9', 'spread': '48.6', 'groupId': 'OG002'}, {'value': '34.4', 'spread': '37.3', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 2 Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '3.21', 'spread': '546.5', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '47.9', 'groupId': 'OG001'}, {'value': '8.75', 'spread': '77.7', 'groupId': 'OG002'}, {'value': '16.6', 'spread': '25.6', 'groupId': 'OG003'}, {'value': '4.72', 'spread': '159.8', 'groupId': 'OG004'}, {'value': '12.7', 'spread': '120.5', 'groupId': 'OG005'}, {'value': '9.05', 'spread': '74.4', 'groupId': 'OG006'}, {'value': '13.1', 'spread': '45.2', 'groupId': 'OG007'}]}]}, {'title': 'Cycle 2 Day 1: 30 min Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '685', 'spread': '22.0', 'groupId': 'OG000'}, {'value': '683', 'spread': '20.1', 'groupId': 'OG001'}, {'value': '803', 'spread': '20.1', 'groupId': 'OG002'}, {'value': '834', 'spread': '13.5', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 4 Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '12.2', 'spread': '26.1', 'groupId': 'OG000'}, {'value': '21.1', 'spread': '46.7', 'groupId': 'OG001'}, {'value': '15.3', 'spread': '61.9', 'groupId': 'OG002'}, {'value': '26.2', 'spread': '22.1', 'groupId': 'OG003'}, {'value': '11.2', 'spread': '109.3', 'groupId': 'OG004'}, {'value': '20.7', 'spread': '46.4', 'groupId': 'OG005'}, {'value': '15.2', 'spread': '30.5', 'groupId': 'OG006'}, {'value': '19.6', 'spread': '30.5', 'groupId': 'OG007'}]}]}, {'title': 'Cycle 4 Day 1: 30 min Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '748', 'spread': '23.4', 'groupId': 'OG000'}, {'value': '754', 'spread': '14.4', 'groupId': 'OG001'}, {'value': '734', 'spread': '22.0', 'groupId': 'OG002'}, {'value': '716', 'spread': '13.7', 'groupId': 'OG003'}, {'value': '689', 'spread': '20.9', 'groupId': 'OG004'}, {'value': '645', 'spread': '21.4', 'groupId': 'OG005'}, {'value': '829', 'spread': '20.3', 'groupId': 'OG006'}, {'value': '709', 'spread': '10.1', 'groupId': 'OG007'}]}]}, {'title': 'Unscheduled Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '41.1', 'spread': '49.4', 'groupId': 'OG005'}, {'value': '53.0', 'spread': '58.0', 'groupId': 'OG006'}]}]}, {'title': 'Unscheduled Visit: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1.21', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG004'}, {'value': '0.180', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG005'}]}]}, {'title': 'Unscheduled Visit: 30 min Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '915', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG005'}]}]}, {'title': 'Study Treatment Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '18.7', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG002'}, {'value': '10.7', 'spread': '181.7', 'groupId': 'OG004'}, {'value': '14.2', 'spread': '95.7', 'groupId': 'OG005'}, {'value': '14.9', 'spread': '69.4', 'groupId': 'OG006'}, {'value': '12.3', 'spread': '109.4', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 2: pre-dose and 30 minutes (min) post dose; Cycle 1 Days 8 and 15; Cycle 2 and 4 Day 1: pre-dose and 30 min post dose; unscheduled visits: pre-dose and 30 min post dose; study treatment completion (up to approximately 84 months)', 'description': 'PK of pola-related analyte acMMAE was measured. Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Phase Ib and Phase II who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint."}, {'type': 'SECONDARY', 'title': 'Arm G+H (Phase II NF Cohorts): Plasma Concentration of of Polatuzumab Vedotin Analyte: acMMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'title': 'Cycle 1 Day 2: Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '653', 'spread': '237', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.6', 'spread': '8.66', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 Day 1: Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '667', 'spread': '155', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4 Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.2', 'spread': '8.59', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4 Day 1: Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '659', 'spread': '156', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 2: post dose; Cycle 2 and 4 Day 1: pre-dose and post dose', 'description': 'PK of one pola-related analytes: acMMAE was measured. Cycle length is 21 days for DLBCL cohorts. As pre-specified in the protocol data is reported combined for arms G+H.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Arm G+H (Phase II NF Cohort) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint."}, {'type': 'SECONDARY', 'title': 'Serum Concentration of of Polatuzumab Vedotin Analyte: Total Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG002', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG003', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG004', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG005', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG006', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG007', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'title': 'Cycle 1 Day 2: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG007'}]}]}, {'title': 'Cycle 1 Day 2: 30 min Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '33.2', 'spread': '28.4', 'groupId': 'OG000'}, {'value': '36.6', 'spread': '25.4', 'groupId': 'OG001'}, {'value': '37.5', 'spread': '29.1', 'groupId': 'OG002'}, {'value': '34.3', 'spread': '20.3', 'groupId': 'OG003'}, {'value': '35.4', 'spread': '27.7', 'groupId': 'OG004'}, {'value': '34.6', 'spread': '26.2', 'groupId': 'OG005'}, {'value': '32.4', 'spread': '22.8', 'groupId': 'OG006'}, {'value': '38.3', 'spread': '20.3', 'groupId': 'OG007'}]}]}, {'title': 'Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '3.43', 'spread': '4393.4', 'groupId': 'OG000'}, {'value': '9.01', 'spread': '43.7', 'groupId': 'OG001'}, {'value': '10.2', 'spread': '39.3', 'groupId': 'OG002'}, {'value': '10.0', 'spread': '31.9', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1.83', 'spread': '1784.3', 'groupId': 'OG000'}, {'value': '4.26', 'spread': '35.3', 'groupId': 'OG001'}, {'value': '4.61', 'spread': '40.6', 'groupId': 'OG002'}, {'value': '5.22', 'spread': '28.4', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 2 Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.696', 'spread': '941.2', 'groupId': 'OG000'}, {'value': '2.31', 'spread': '54.2', 'groupId': 'OG001'}, {'value': '2.20', 'spread': '76.1', 'groupId': 'OG002'}, {'value': '3.70', 'spread': '27.4', 'groupId': 'OG003'}, {'value': '1.23', 'spread': '203.1', 'groupId': 'OG004'}, {'value': '2.48', 'spread': '137.6', 'groupId': 'OG005'}, {'value': '2.20', 'spread': '100.6', 'groupId': 'OG006'}, {'value': '2.83', 'spread': '41.8', 'groupId': 'OG007'}]}]}, {'title': 'Cycle 2 Day 1: 30 min Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '35.8', 'spread': '25.9', 'groupId': 'OG000'}, {'value': '39.5', 'spread': '28.3', 'groupId': 'OG001'}, {'value': '43.4', 'spread': '31.1', 'groupId': 'OG002'}, {'value': '42.2', 'spread': '22.9', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 4 Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '3.44', 'spread': '30.5', 'groupId': 'OG000'}, {'value': '5.03', 'spread': '59.0', 'groupId': 'OG001'}, {'value': '4.61', 'spread': '62.2', 'groupId': 'OG002'}, {'value': '6.26', 'spread': '18.3', 'groupId': 'OG003'}, {'value': '3.61', 'spread': '97.8', 'groupId': 'OG004'}, {'value': '5.72', 'spread': '39.9', 'groupId': 'OG005'}, {'value': '4.82', 'spread': '20.8', 'groupId': 'OG006'}, {'value': '5.03', 'spread': '29.3', 'groupId': 'OG007'}]}]}, {'title': 'Cycle 4 Day 1: 30 min Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '40.2', 'spread': '27.2', 'groupId': 'OG000'}, {'value': '44.6', 'spread': '11.0', 'groupId': 'OG001'}, {'value': '43.0', 'spread': '25.8', 'groupId': 'OG002'}, {'value': '47.1', 'spread': '24.2', 'groupId': 'OG003'}, {'value': '44.8', 'spread': '24.3', 'groupId': 'OG004'}, {'value': '40.6', 'spread': '20.6', 'groupId': 'OG005'}, {'value': '55.0', 'spread': '21.3', 'groupId': 'OG006'}, {'value': '37.5', 'spread': '11.6', 'groupId': 'OG007'}]}]}, {'title': 'Follow up on Month 3, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.164', 'spread': '51.9', 'groupId': 'OG000'}, {'value': '0.771', 'spread': '193.4', 'groupId': 'OG001'}, {'value': '0.910', 'spread': '82.8', 'groupId': 'OG002'}, {'value': '0.394', 'spread': '27.1', 'groupId': 'OG003'}, {'value': '0.265', 'spread': '209.9', 'groupId': 'OG004'}, {'value': '0.316', 'spread': '266.2', 'groupId': 'OG005'}, {'value': '0.489', 'spread': '174.2', 'groupId': 'OG006'}, {'value': '0.543', 'spread': '126.7', 'groupId': 'OG007'}]}]}, {'title': 'Follow up on Month 6, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.0250', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.0788', 'spread': '230.0', 'groupId': 'OG001'}, {'value': '0.219', 'spread': '96.6', 'groupId': 'OG002'}, {'value': '0.104', 'spread': '18.5', 'groupId': 'OG003'}, {'value': '0.0539', 'spread': '145.7', 'groupId': 'OG004'}, {'value': '0.0564', 'spread': '195.7', 'groupId': 'OG005'}, {'value': '0.0920', 'spread': '123.5', 'groupId': 'OG006'}, {'value': '0.150', 'spread': '206.6', 'groupId': 'OG007'}]}]}, {'title': 'Follow up on Month 12, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.0250', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.0250', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '0.0298', 'spread': '35.9', 'groupId': 'OG002'}, {'value': '0.0250', 'spread': '0.0', 'groupId': 'OG003'}, {'value': '0.0250', 'spread': '0.0', 'groupId': 'OG004'}, {'value': '0.0301', 'spread': '60.6', 'groupId': 'OG005'}, {'value': '0.0250', 'spread': '0.0', 'groupId': 'OG006'}, {'value': '0.0250', 'spread': '0.0', 'groupId': 'OG007'}]}]}, {'title': 'Follow up on Month 18, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.0250', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.0250', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '0.0250', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '0.0250', 'spread': '0.0', 'groupId': 'OG003'}, {'value': '0.0250', 'spread': '0.0', 'groupId': 'OG004'}, {'value': '0.0250', 'spread': '0.0', 'groupId': 'OG006'}, {'value': '0.0250', 'spread': '0.0', 'groupId': 'OG007'}]}]}, {'title': 'Follow up on Month 24, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.0250', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.0250', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '0.0250', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG002'}, {'value': '0.0250', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated..', 'groupId': 'OG003'}, {'value': '0.0250', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG007'}]}]}, {'title': 'Unscheduled Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.0250', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.0250', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '0.0250', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG003'}, {'value': '1.65', 'spread': '5419.8', 'groupId': 'OG005'}, {'value': '1.23', 'spread': '30267.8', 'groupId': 'OG006'}]}]}, {'title': 'Unscheduled Visit: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.279', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG004'}, {'value': '0.0250', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG005'}]}]}, {'title': 'Unscheduled Visit: 30 min Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '42.0', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG005'}]}]}, {'title': 'Study Treatment Completion Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '5.34', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG002'}, {'value': '3.34', 'spread': '180.5', 'groupId': 'OG004'}, {'value': '4.33', 'spread': '69.4', 'groupId': 'OG005'}, {'value': '4.57', 'spread': '57.2', 'groupId': 'OG006'}, {'value': '3.23', 'spread': '79.3', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Days 2: pre-dose & 30 min post dose; Cycle 1 Days 8 & 15; Cycle 2 and 4 Day 1 and unscheduled visits: pre-dose & 30 min post dose; Follow up at Day 1: Months 3, 6, 12, 18 & 24; study treatment completion visit (up to approx. 84 months)', 'description': 'PK of pola-related analyte Total Ab was measured. Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts.', 'unitOfMeasure': 'grams per milliliters (g/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants Phase Ib and Phase II who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint."}, {'type': 'SECONDARY', 'title': 'Arm G+H (Phase II NF Cohorts): Plasma Concentration of Polatuzumab Vedotin Analyte: Total Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'title': 'Cycle 1 Day 2: Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.9', 'spread': '11.7', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.27', 'spread': '4.37', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 Day 1: Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.0', 'spread': '8.71', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4 Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.41', 'spread': '1.79', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4 Day 1: Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39.2', 'spread': '7.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 2: post dose; Cycle 2 and 4 Day 1: pre-dose and post dose', 'description': 'PK of pola-related analyte: Total Ab was measured. Cycle length is 21 days for DLBCL cohorts. As pre-specified in the protocol data is reported combined for arms G+H.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Arm G+H (Phase II NF Cohort) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint."}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG002', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG003', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG004', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG005', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG006', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG007', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'title': 'Cycle 1 Day 2: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG007'}]}]}, {'title': 'Cycle 1 Day 2: 30 min Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.726', 'spread': '297.5', 'groupId': 'OG000'}, {'value': '0.234', 'spread': '80.2', 'groupId': 'OG001'}, {'value': '0.397', 'spread': '67.7', 'groupId': 'OG002'}, {'value': '0.327', 'spread': '41.4', 'groupId': 'OG003'}, {'value': '0.402', 'spread': '80.2', 'groupId': 'OG004'}, {'value': '0.315', 'spread': '105.3', 'groupId': 'OG005'}, {'value': '0.243', 'spread': '101.8', 'groupId': 'OG006'}, {'value': '0.456', 'spread': '103.1', 'groupId': 'OG007'}]}]}, {'title': 'Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1.48', 'spread': '100.8', 'groupId': 'OG000'}, {'value': '1.84', 'spread': '78.4', 'groupId': 'OG001'}, {'value': '1.96', 'spread': '51.5', 'groupId': 'OG002'}, {'value': '2.34', 'spread': '21.4', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.311', 'spread': '93.8', 'groupId': 'OG000'}, {'value': '0.531', 'spread': '88.5', 'groupId': 'OG001'}, {'value': '0.705', 'spread': '60.0', 'groupId': 'OG002'}, {'value': '0.688', 'spread': '19.5', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 2 Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.0264', 'spread': '70.8', 'groupId': 'OG000'}, {'value': '0.158', 'spread': '79.4', 'groupId': 'OG001'}, {'value': '0.0512', 'spread': '129.3', 'groupId': 'OG002'}, {'value': '0.150', 'spread': '44.4', 'groupId': 'OG003'}, {'value': '0.0373', 'spread': '81.5', 'groupId': 'OG004'}, {'value': '0.159', 'spread': '80.9', 'groupId': 'OG005'}, {'value': '0.0451', 'spread': '76.9', 'groupId': 'OG006'}, {'value': '0.186', 'spread': '86.8', 'groupId': 'OG007'}]}]}, {'title': 'Cycle 2 Day 1: 30 min Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.185', 'spread': '54.2', 'groupId': 'OG000'}, {'value': '0.263', 'spread': '72.7', 'groupId': 'OG001'}, {'value': '0.231', 'spread': '53.5', 'groupId': 'OG002'}, {'value': '0.345', 'spread': '31.9', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 4 Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.0414', 'spread': '102.9', 'groupId': 'OG000'}, {'value': '0.133', 'spread': '72.6', 'groupId': 'OG001'}, {'value': '0.0511', 'spread': '68.3', 'groupId': 'OG002'}, {'value': '0.150', 'spread': '44.3', 'groupId': 'OG003'}, {'value': '0.0554', 'spread': '77.3', 'groupId': 'OG004'}, {'value': '0.158', 'spread': '58.2', 'groupId': 'OG005'}, {'value': '0.0481', 'spread': '83.2', 'groupId': 'OG006'}, {'value': '0.141', 'spread': '102.3', 'groupId': 'OG007'}]}]}, {'title': 'Cycle 4 Day 1: 30 min Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.234', 'spread': '35.0', 'groupId': 'OG000'}, {'value': '0.266', 'spread': '27.0', 'groupId': 'OG001'}, {'value': '0.167', 'spread': '39.2', 'groupId': 'OG002'}, {'value': '0.257', 'spread': '32.3', 'groupId': 'OG003'}, {'value': '0.198', 'spread': '32.0', 'groupId': 'OG004'}, {'value': '0.316', 'spread': '38.9', 'groupId': 'OG005'}, {'value': '0.195', 'spread': '38.1', 'groupId': 'OG006'}, {'value': '0.283', 'spread': '56.9', 'groupId': 'OG007'}]}]}, {'title': 'Unscheduled Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.738', 'spread': '64.6', 'groupId': 'OG006'}]}]}, {'title': 'Unscheduled Visit: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.0180', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG004'}, {'value': '0.0180', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG005'}]}]}, {'title': 'Unscheduled Visit: 30 min Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.114', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG005'}]}]}, {'title': 'Study Treatment Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.0595', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG002'}, {'value': '0.0506', 'spread': '113.0', 'groupId': 'OG004'}, {'value': '0.0749', 'spread': '165.9', 'groupId': 'OG005'}, {'value': '0.0682', 'spread': '110.4', 'groupId': 'OG006'}, {'value': '0.150', 'spread': '179.4', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 2: pre-dose and 30 min post dose, Cycle 1 Days 8 and 15; Cycles 2 and 4: pre-dose and 30 min post dose; unscheduled visits: pre-dose and 30 min post dose; study treatment completion (up to approximately 84 months)', 'description': 'PK of pola-related analytes unconjugated MMAE was measured. Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants Phase Ib and Phase II who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis."}, {'type': 'SECONDARY', 'title': 'Arm G+H (Phase II NF Cohorts): Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'title': 'Cycle 1 Day 2: Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.590', 'spread': '1.08', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.229', 'spread': '0.248', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 Day 1: Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.316', 'spread': '0.213', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4 Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.186', 'spread': '0.118', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4 Day 1: Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.256', 'spread': '0.118', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 2: post dose; Cycle 1 and 3 Day 8 and 15; Cycle 2, 3 and 4 Day 1: pre-dose and post dose', 'description': 'PK of one pola-related analytes: Unconjugated MMAE was measured. Cycle length is 21 days for DLBCL cohorts. As pre-specified in the protocol data is reported combined for arms G+H.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Arm G (Phase II NF Cohort) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint."}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of Bendamustine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '18', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG002', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG003', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG004', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG005', 'title': 'Arm B (Phase II Randomization): BR in FL', 'description': 'Participants with FL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG006', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG007', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG008', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG009', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'title': 'Cycle 1 Day 2: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '18', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG008'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG009'}]}]}, {'title': 'Cycle 1 Day 2: 5 min Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}, {'value': '31', 'groupId': 'OG007'}, {'value': '18', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '2130', 'spread': '665.6', 'groupId': 'OG004'}, {'value': '2810', 'spread': '222.7', 'groupId': 'OG005'}, {'value': '2740', 'spread': '550.9', 'groupId': 'OG006'}, {'value': '1700', 'spread': '1865.5', 'groupId': 'OG007'}, {'value': '3090', 'spread': '68.3', 'groupId': 'OG008'}, {'value': '3790', 'spread': '119.4', 'groupId': 'OG009'}]}]}, {'title': 'Cycle 1 Day 2: 1h Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}, {'value': '31', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '456', 'spread': '167.8', 'groupId': 'OG004'}, {'value': '353', 'spread': '187.9', 'groupId': 'OG005'}, {'value': '518', 'spread': '154.2', 'groupId': 'OG006'}, {'value': '451', 'spread': '380.2', 'groupId': 'OG007'}, {'value': '478', 'spread': '111.4', 'groupId': 'OG008'}, {'value': '639', 'spread': '165.6', 'groupId': 'OG009'}]}]}, {'title': 'Cycle 1 Day 2: 2h Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '16', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '84.4', 'spread': '173.5', 'groupId': 'OG004'}, {'value': '55.1', 'spread': '236.5', 'groupId': 'OG005'}, {'value': '93.8', 'spread': '250.5', 'groupId': 'OG006'}, {'value': '101', 'spread': '375.8', 'groupId': 'OG007'}, {'value': '62.8', 'spread': '104.3', 'groupId': 'OG008'}, {'value': '128', 'spread': '196.7', 'groupId': 'OG009'}]}]}, {'title': 'Cycle 1 Day 2: 3h Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}, {'value': '32', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '20.5', 'spread': '220.1', 'groupId': 'OG004'}, {'value': '12.7', 'spread': '246.4', 'groupId': 'OG005'}, {'value': '23.5', 'spread': '461.0', 'groupId': 'OG006'}, {'value': '21.5', 'spread': '509.9', 'groupId': 'OG007'}, {'value': '12.4', 'spread': '132.0', 'groupId': 'OG008'}, {'value': '28.2', 'spread': '287.4', 'groupId': 'OG009'}]}]}, {'title': 'Cycle 1 Day 2: 4h Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '7.60', 'spread': '278.5', 'groupId': 'OG004'}, {'value': '4.58', 'spread': '268.4', 'groupId': 'OG005'}, {'value': '8.11', 'spread': '724.8', 'groupId': 'OG006'}, {'value': '8.08', 'spread': '615.9', 'groupId': 'OG007'}, {'value': '3.30', 'spread': '147.2', 'groupId': 'OG008'}, {'value': '6.18', 'spread': '131.0', 'groupId': 'OG009'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 2: pre-dose, 5 min, 1 hour (h); 2h, 3h and 4h post dose', 'description': 'Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts. As pre specified in the protocol plasma concentration of bendamustine was not assessed in the Phase II NF Cohort (Arm G+H).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants Phase Ib and Phase II who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint."}, {'type': 'SECONDARY', 'title': 'Serum Concentration of Rituximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG002', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG003', 'title': 'Arm B (Phase II Randomization): BR in FL', 'description': 'Participants with FL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG004', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG005', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}], 'classes': [{'title': 'Cycle 1 Days 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG005'}]}]}, {'title': 'Cycle 1 Days 1: 30 min Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '182', 'spread': '27.2', 'groupId': 'OG002'}, {'value': '202', 'spread': '24.5', 'groupId': 'OG003'}, {'value': '188', 'spread': '19.9', 'groupId': 'OG004'}, {'value': '180', 'spread': '18.0', 'groupId': 'OG005'}]}]}, {'title': 'Cycle 2 Days 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '22.8', 'spread': '79.2', 'groupId': 'OG002'}, {'value': '20.2', 'spread': '145.9', 'groupId': 'OG003'}, {'value': '34.9', 'spread': '89.9', 'groupId': 'OG004'}, {'value': '34.6', 'spread': '69.7', 'groupId': 'OG005'}]}]}, {'title': 'Cycle 4 Days 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '65.1', 'spread': '46.5', 'groupId': 'OG002'}, {'value': '62.3', 'spread': '42.7', 'groupId': 'OG003'}, {'value': '74.7', 'spread': '50.9', 'groupId': 'OG004'}, {'value': '83.3', 'spread': '49.1', 'groupId': 'OG005'}]}]}, {'title': 'Unscheduled: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '30.6', 'spread': '118.0', 'groupId': 'OG002'}, {'value': '298', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG004'}, {'value': '2.00', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG005'}]}]}, {'title': 'Unscheduled: 30 min Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '165', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Days 1: pre-dose and 30 min post dose; Cycle 2 and 4 Day 1: pre-dose; unscheduled visits: pre-dose and 30 min post dose (up to approximately 84 months)', 'description': 'Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts. As pre specified in the protocol serum concentration of rituximab was not assessed in the Phase II NF Cohort (Arm G+H).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Cohort 1a (Phase Ib) and Arms A-D (Phase II) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint."}, {'type': 'SECONDARY', 'title': 'Serum Concentration of Obinutuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG001', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG002', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG003', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'title': 'Cycle 1 Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data is not evaluable as the samples were BLLQ.', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 1 Day 1: 30 min Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '341', 'spread': '22.1', 'groupId': 'OG002'}, {'value': '221', 'spread': '105.5', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 2 Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '283', 'spread': '38.4', 'groupId': 'OG000'}, {'value': '412', 'spread': '40.8', 'groupId': 'OG001'}, {'value': '301', 'spread': '39.3', 'groupId': 'OG002'}, {'value': '349', 'spread': '58.0', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 4 Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '293', 'spread': '53.8', 'groupId': 'OG000'}, {'value': '359', 'spread': '28.9', 'groupId': 'OG001'}, {'value': '291', 'spread': '37.9', 'groupId': 'OG002'}, {'value': '290', 'spread': '36.4', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 4 Day 1: 30 min Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '701', 'spread': '27.4', 'groupId': 'OG002'}, {'value': '642', 'spread': '29.5', 'groupId': 'OG003'}]}]}, {'title': 'Follow up on Month 3, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '67.7', 'spread': '47.8', 'groupId': 'OG000'}, {'value': '28.8', 'spread': '17.0', 'groupId': 'OG001'}, {'value': '38.5', 'spread': '167.8', 'groupId': 'OG002'}, {'value': '55.1', 'spread': '119.9', 'groupId': 'OG003'}]}]}, {'title': 'Follow up on Month 6, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.5', 'spread': '56.6', 'groupId': 'OG000'}, {'value': '5.38', 'spread': '12.4', 'groupId': 'OG001'}, {'value': '7.64', 'spread': '412.2', 'groupId': 'OG002'}, {'value': '15.8', 'spread': '137.6', 'groupId': 'OG003'}]}]}, {'title': 'Follow up on Month 12, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.237', 'spread': '717.6', 'groupId': 'OG000'}, {'value': '0.389', 'spread': '119.3', 'groupId': 'OG001'}, {'value': '0.162', 'spread': '569.7', 'groupId': 'OG002'}, {'value': '0.732', 'spread': '18.7', 'groupId': 'OG003'}]}]}, {'title': 'Follow up on Month 18, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.00978', 'spread': '1188.5', 'groupId': 'OG000'}, {'value': '0.0107', 'spread': '170.5', 'groupId': 'OG001'}, {'value': '0.00842', 'spread': '347.4', 'groupId': 'OG002'}, {'value': '0.0460', 'spread': '86.9', 'groupId': 'OG003'}]}]}, {'title': 'Follow up on Month 24, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.00203', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG000'}, {'value': '0.00203', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG001'}, {'value': '0.00203', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG003'}]}]}, {'title': 'Unscheduled', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.09', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG001'}, {'value': '20.8', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG002'}]}]}, {'title': 'Unscheduled Visit: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0626', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG003'}]}]}, {'title': 'Unscheduled Visit: 30 min Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '349', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG003'}]}]}, {'title': 'Study Treatment Completion Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '367', 'spread': 'NA', 'comment': 'Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.', 'groupId': 'OG000'}, {'value': '242', 'spread': '52.7', 'groupId': 'OG002'}, {'value': '232', 'spread': '46.2', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycles 1 and 4 Days 1: pre-dose and 30 min post dose; Cycle 2 Day1: pre-dose; Follow up visits on Day 1: Months 3, 6, 12, 18 and 24; unscheduled visits: pre-dose and 30 min post dose; study treatment completion (up to approximately 84 months)', 'description': 'Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts.', 'unitOfMeasure': 'g/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants who Cohort 1b (Phase 1b) and Arms E and F (Phase II) received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint."}, {'type': 'SECONDARY', 'title': 'Phase Ib: Cmax of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'title': 'acMMAE: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '676', 'spread': '176', 'groupId': 'OG000'}, {'value': '634', 'spread': '158', 'groupId': 'OG001'}]}]}, {'title': 'acMMAE: Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '697', 'spread': '129', 'groupId': 'OG000'}, {'value': '694', 'spread': '138', 'groupId': 'OG001'}]}]}, {'title': 'acMMAE: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '763', 'spread': '159', 'groupId': 'OG000'}, {'value': '759', 'spread': '107', 'groupId': 'OG001'}]}]}, {'title': 'Total Ab: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.3', 'spread': '8.57', 'groupId': 'OG000'}, {'value': '37.6', 'spread': '9.42', 'groupId': 'OG001'}]}]}, {'title': 'Total Ab: Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.6', 'spread': '8.00', 'groupId': 'OG000'}, {'value': '40.6', 'spread': '9.46', 'groupId': 'OG001'}]}]}, {'title': 'Total Ab: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.3', 'spread': '9.98', 'groupId': 'OG000'}, {'value': '44.8', 'spread': '5.06', 'groupId': 'OG001'}]}]}, {'title': 'Unconjugated MMAE: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.31', 'spread': '4.00', 'groupId': 'OG000'}, {'value': '2.21', 'spread': '1.34', 'groupId': 'OG001'}]}]}, {'title': 'Unconjugated MMAE: Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Unconjugated MMAE: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bendamustine: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bendamustine: Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bendamustine: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rituximab: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rituximab: Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rituximab: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycles 1, 2 and 4 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Cohort 1a (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Cmax was not evaluated for Bendamustine and Rituximab."}, {'type': 'SECONDARY', 'title': 'Phase Ib: Cmax of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG001', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'title': 'acMMAE: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '738', 'spread': '165', 'groupId': 'OG000'}, {'value': '725', 'spread': '104', 'groupId': 'OG001'}]}]}, {'title': 'acMMAE: Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '816', 'spread': '168', 'groupId': 'OG000'}, {'value': '841', 'spread': '115', 'groupId': 'OG001'}]}]}, {'title': 'acMMAE: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '749', 'spread': '158', 'groupId': 'OG000'}, {'value': '721', 'spread': '97.7', 'groupId': 'OG001'}]}]}, {'title': 'Total Ab: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.7', 'spread': '9.84', 'groupId': 'OG000'}, {'value': '34.9', 'spread': '7.52', 'groupId': 'OG001'}]}]}, {'title': 'Total Ab: Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.0', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '43.1', 'spread': '9.52', 'groupId': 'OG001'}]}]}, {'title': 'Total Ab: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.2', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '48.2', 'spread': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'Unconjugated MMAE: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.17', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '2.39', 'spread': '0.492', 'groupId': 'OG001'}]}]}, {'title': 'Unconjugated MMAE: Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Unconjugated MMAE: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bendamustine: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bendamustine: Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bendamustine: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rituximab: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rituximab: Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rituximab: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycles 1, 2 and 4 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants Cohort 1b (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Cmax was not evaluated for Bendamustine and Obinutuzumab."}, {'type': 'SECONDARY', 'title': 'Phase II: Cmax of Polatuzumab Vedotin, Bendamustine, and Rituximab in Arms A and C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'title': 'acMMAE: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '622', 'spread': '194', 'groupId': 'OG000'}, {'value': '661', 'spread': '149', 'groupId': 'OG001'}]}]}, {'title': 'acMMAE: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '703', 'spread': '150', 'groupId': 'OG000'}, {'value': '659', 'spread': '135', 'groupId': 'OG001'}]}]}, {'title': 'Total Ab: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.7', 'spread': '9.54', 'groupId': 'OG000'}, {'value': '35.7', 'spread': '8.50', 'groupId': 'OG001'}]}]}, {'title': 'Total Ab: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.1', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '41.4', 'spread': '8.29', 'groupId': 'OG001'}]}]}, {'title': 'Unconjugated MMAE: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Unconjugated MMAE: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bendamustine: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.57', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '4.23', 'spread': '2.26', 'groupId': 'OG001'}]}]}, {'title': 'Bendamustine: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rituximab: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '188', 'spread': '49.2', 'groupId': 'OG000'}, {'value': '191', 'spread': '35.9', 'groupId': 'OG001'}]}]}, {'title': 'Rituximab: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1; Cycle 4 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody and unconjugated MMAE were measured.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Arms A and C who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints."}, {'type': 'SECONDARY', 'title': 'Phase II: Cmax of Bendamustine and Rituximab in Arms B and D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm B (Phase II Randomization): BR in FL', 'description': 'Participants with FL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG001', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}], 'classes': [{'title': 'Bendamustine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.21', 'spread': '2.09', 'groupId': 'OG000'}, {'value': '3.85', 'spread': '2.91', 'groupId': 'OG001'}]}]}, {'title': 'Rituximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '207', 'spread': '50.1', 'groupId': 'OG000'}, {'value': '183', 'spread': '33.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Arms B and D who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints."}, {'type': 'SECONDARY', 'title': 'Phase II: Cmax of Polatuzumab Vedotin, Obinutuzumab and Bendamustine in Arms E and F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG001', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'title': 'acMMAE: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '692', 'spread': '230', 'groupId': 'OG000'}, {'value': '703', 'spread': '211', 'groupId': 'OG001'}]}]}, {'title': 'acMMAE: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '845', 'spread': '165', 'groupId': 'OG000'}, {'value': '713', 'spread': '70.6', 'groupId': 'OG001'}]}]}, {'title': 'Total Ab: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.3', 'spread': '8.04', 'groupId': 'OG000'}, {'value': '39.0', 'spread': '7.63', 'groupId': 'OG001'}]}]}, {'title': 'Total Ab: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.1', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '37.8', 'spread': '4.51', 'groupId': 'OG001'}]}]}, {'title': 'Unconjugated MMAE: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Unconjugated MMAE: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bendamustine: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.30', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '5.47', 'spread': '4.30', 'groupId': 'OG001'}]}]}, {'title': 'Bendamustine: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Obinutuzumab: Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '349', 'spread': '72.8', 'groupId': 'OG000'}, {'value': '274', 'spread': '118', 'groupId': 'OG001'}]}]}, {'title': 'Obinutuzumab: Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '727', 'spread': '217', 'groupId': 'OG000'}, {'value': '666', 'spread': '190', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1; Cycle 4 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, unconjugated MMAE and total antibody were measured.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Arms E and F who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints."}, {'type': 'SECONDARY', 'title': 'Arm H (Phase II NF Cohort): Cmax of Polatuzumab Vedotin (Lyophilized)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'timeFrame': 'Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4,(cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.', 'reportingStatus': 'POSTED', 'populationDescription': "As pre-specified in the protocol the analysis of this OM was based on sponsor's discretion however, sponsor opted to not collect data for this OM."}, {'type': 'SECONDARY', 'title': 'Phase Ib: AUC From Time Zero to Infinity (AUCinf) of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'title': 'acMMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2830', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '2110', 'spread': '28.4', 'groupId': 'OG001'}]}]}, {'title': 'Total Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '298', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '214', 'spread': '35.9', 'groupId': 'OG001'}]}]}, {'title': 'Unconjugated MMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bendamustine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rituximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured. The unit of measure for AUC is day\\*micrograms per milliliter \\[day\\*ug/mL\\]).', 'unitOfMeasure': 'day*ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Cohort 1a (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema AUC was not evaluated for bendamustine and rituximab."}, {'type': 'SECONDARY', 'title': 'Phase Ib: AUCinf of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG001', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'title': 'acMMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2600', 'spread': '34.4', 'groupId': 'OG000'}, {'value': '2650', 'spread': '16.4', 'groupId': 'OG001'}]}]}, {'title': 'Total Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '267', 'spread': '30.2', 'groupId': 'OG000'}, {'value': '252', 'spread': '21.6', 'groupId': 'OG001'}]}]}, {'title': 'Unconjugated MMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bendamustine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Obinutuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.', 'unitOfMeasure': 'day*ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Cohort 1b (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema AUC was not evaluated for bendamustine and obinutuzumab."}, {'type': 'SECONDARY', 'title': 'Phase II: AUCinf of Polatuzumab Vedotin, Bendamustine, and Rituximab in Arms A and C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'title': 'acMMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Unconjugated MMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bendamustine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.29', 'spread': '73.3', 'groupId': 'OG000'}, {'value': '3.62', 'spread': '78.5', 'groupId': 'OG001'}]}]}, {'title': 'Rituximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.', 'unitOfMeasure': 'h*ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Arms A and C who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema AUC was not evaluated for pola and rituximab."}, {'type': 'SECONDARY', 'title': 'Phase II: AUCinf of Bendamustine and Rituximab in Arms B and D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm B (Phase II Randomization): BR in FL', 'description': 'Participants with FL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG001', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}], 'classes': [{'title': 'Bendamustine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.86', 'spread': '67.3', 'groupId': 'OG000'}, {'value': '3.43', 'spread': '97.4', 'groupId': 'OG001'}]}]}, {'title': 'Rituximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'unitOfMeasure': 'h*ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Arms B and D who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema AUC was not evaluated for rituximab."}, {'type': 'SECONDARY', 'title': 'Phase II: AUCinf of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Arms E and F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG001', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'title': 'acMMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Unconjugated MMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bendamustine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.88', 'spread': '28.9', 'groupId': 'OG000'}, {'value': '4.10', 'spread': '67.4', 'groupId': 'OG001'}]}]}, {'title': 'Obinutuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.', 'unitOfMeasure': 'h*ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Arms E and F who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema AUC was not evaluated for pola and obinutuzumab."}, {'type': 'SECONDARY', 'title': 'Arm H (Phase II NF Cohort): AUC of Polatuzumab Vedotin (Lyophilized)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'timeFrame': 'Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (each cycle is 21 days DLBCL cohorts) up to approximately 9 weeks', 'description': 'PK of three pola-related analytes: antibody acMMAE, total antibody, and unconjugated MMAE were measured.', 'reportingStatus': 'POSTED', 'populationDescription': "As pre-specified in the protocol the analysis of this OM was based on sponsor's discretion however, sponsor opted to not collect data for this OM."}, {'type': 'SECONDARY', 'title': 'Phase Ib: CL of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'title': 'acMMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.3', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '15.2', 'spread': '27.9', 'groupId': 'OG001'}]}]}, {'title': 'Total Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.05', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '8.48', 'spread': '35.2', 'groupId': 'OG001'}]}]}, {'title': 'Unconjugated MMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bendamustine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rituximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.', 'unitOfMeasure': 'mL/day/kg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Cohort 1a (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema CL was not evaluated for bendamustine and rituximab."}, {'type': 'SECONDARY', 'title': 'Phase Ib: CL of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG001', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'title': 'acMMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.3', 'spread': '34.9', 'groupId': 'OG000'}, {'value': '12.1', 'spread': '17.0', 'groupId': 'OG001'}]}]}, {'title': 'Total Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.76', 'spread': '30.6', 'groupId': 'OG000'}, {'value': '7.17', 'spread': '22.2', 'groupId': 'OG001'}]}]}, {'title': 'Unconjugated MMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bendamustine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Obinutuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.', 'unitOfMeasure': 'mL/day/kg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Cohort 1b (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema CL was not evaluated for bendamustine and obinutuzumab."}, {'type': 'SECONDARY', 'title': 'Phase II: CL of Polatuzumab Vedotin, Bendamustine and Rituximab in Arms A and C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'title': 'acMMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Unconjugated MMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bendamustine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.9', 'spread': '60.8', 'groupId': 'OG000'}, {'value': '42.6', 'spread': '66.4', 'groupId': 'OG001'}]}]}, {'title': 'Rituximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.', 'unitOfMeasure': 'Liters per hour (L/h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Arms A and B who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema CL was not evaluated for pola and rituximab."}, {'type': 'SECONDARY', 'title': 'Phase II: CL of Bendamustine and Rituximab in Arms B and D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm B (Phase II Randomization): BR in FL', 'description': 'Participants with FL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG001', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}], 'classes': [{'title': 'Bendamustine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.4', 'spread': '60.9', 'groupId': 'OG000'}, {'value': '46.4', 'spread': '93.9', 'groupId': 'OG001'}]}]}, {'title': 'Rituximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'unitOfMeasure': 'L/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Arms B and D who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema CL was not evaluated for rituximab."}, {'type': 'SECONDARY', 'title': 'Phase II: CL of Polatuzumab Vedotin, Bendamustine and Obinutuzumab in Arms E and F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG001', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'title': 'acMMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Uncojugated MMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bendamustine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.3', 'spread': '33.4', 'groupId': 'OG000'}, {'value': '39.9', 'spread': '76.1', 'groupId': 'OG001'}]}]}, {'title': 'Obinutuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.', 'unitOfMeasure': 'L/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Arms E and F who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema AUC was not evaluated for pola and obinutuzumab."}, {'type': 'SECONDARY', 'title': 'Arm H (Phase II NF Cohort): CL of Polatuzumab Vedotin (Lyophilized)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'timeFrame': 'Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.', 'reportingStatus': 'POSTED', 'populationDescription': "As pre-specified in the protocol the analysis of this OM was based on sponsor's discretion however, sponsor opted to not collect data for this OM."}, {'type': 'SECONDARY', 'title': 'Phase Ib: Vss of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1a', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'title': 'acMMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.0', 'spread': '22.3', 'groupId': 'OG000'}, {'value': '82.7', 'spread': '33.2', 'groupId': 'OG001'}]}]}, {'title': 'Total Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.3', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '76.6', 'spread': '25.7', 'groupId': 'OG001'}]}]}, {'title': 'Unconjugated MMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bendamustine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rituximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.', 'unitOfMeasure': 'mL/kg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Cohort 1a (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Vss was not evaluated for bendamustine and rituximab."}, {'type': 'SECONDARY', 'title': 'Phase Ib: Vss of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG001', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'title': 'acMMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.2', 'spread': '38.8', 'groupId': 'OG000'}, {'value': '64.7', 'spread': '23.0', 'groupId': 'OG001'}]}]}, {'title': 'Total Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.5', 'spread': '38.5', 'groupId': 'OG000'}, {'value': '87.9', 'spread': '24.7', 'groupId': 'OG001'}]}]}, {'title': 'Unconjugated MMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bendamustine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Obinutuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.', 'unitOfMeasure': 'mL/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Cohort 1b (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Vss was not evaluated for bendamustine and obinutuzumab."}, {'type': 'SECONDARY', 'title': 'Phase II: Vss of Polatuzumab Vedotin, Bendamustine and Rituximab in Arms A and C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'title': 'acMMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Unconjugated MMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bendamustine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.5', 'spread': '86.4', 'groupId': 'OG000'}, {'value': '34.3', 'spread': '57.7', 'groupId': 'OG001'}]}]}, {'title': 'Rituximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.', 'unitOfMeasure': 'L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Arms A and C who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Vss was not evaluated for pola and rituximab."}, {'type': 'SECONDARY', 'title': 'Phase II: Vss of Bendamustine and Rituximab in Arms B and D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm B (Phase II Randomization): BR in FL', 'description': 'Participants with FL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG001', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}], 'classes': [{'title': 'Bendamustine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.9', 'spread': '69.6', 'groupId': 'OG000'}, {'value': '33.2', 'spread': '62.9', 'groupId': 'OG001'}]}]}, {'title': 'Rituximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'unitOfMeasure': 'L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Arms B and D who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Vss was not evaluated for rituximab."}, {'type': 'SECONDARY', 'title': 'Phase II: Vss of Polatuzumab Vedotin, Bendamustine and Obinutuzumab in Arms E and F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG001', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'title': 'acMMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Unconjugated MMAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bendamustine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.2', 'spread': '33.6', 'groupId': 'OG000'}, {'value': '31.5', 'spread': '68.1', 'groupId': 'OG001'}]}]}, {'title': 'Obinutuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.', 'unitOfMeasure': 'L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK evaluable population included all the ITT participants in Arms E and F who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Vss was not evaluated for pola and obinutuzumab."}, {'type': 'SECONDARY', 'title': 'Arm H (Phase II NF Cohort): Vss of Polatuzumab Vedotin (Lyophilized)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'classes': [{'title': 'acMMAE'}, {'title': 'MMAE'}, {'title': 'Total Ab'}], 'timeFrame': 'Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, Day (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.', 'reportingStatus': 'POSTED', 'populationDescription': "As pre-specified in the protocol the analysis of this OM was based on sponsor's discretion however, sponsor opted to not collect data for this OM."}, {'type': 'SECONDARY', 'title': 'Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG001', 'title': 'Arm B (Phase II Randomization): BR in FL', 'description': 'Participants with FL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG002', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'OG003', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'OG004', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'OG005', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '0.6', 'spread': '0.7', 'groupId': 'OG003'}, {'value': '0.8', 'spread': '1.6', 'groupId': 'OG004'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.4', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '1.1', 'groupId': 'OG003'}, {'value': '0.2', 'spread': '0.2', 'groupId': 'OG004'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '0.9', 'spread': '0.1', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '0.1', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '0.8', 'groupId': 'OG003'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG004'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '0.6', 'spread': '0.6', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '0.2', 'groupId': 'OG004'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '1.0', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '0.3', 'groupId': 'OG004'}]}]}, {'title': 'Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '0.6', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '0.1', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '0.6', 'spread': '0.9', 'groupId': 'OG003'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG004'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '0.7', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '0.3', 'groupId': 'OG004'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '0.2', 'groupId': 'OG004'}]}]}, {'title': 'Week 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '0.6', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '0.1', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.4', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '0.6', 'groupId': 'OG003'}, {'value': '0.2', 'spread': '0.2', 'groupId': 'OG004'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.4', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG003'}, {'value': '0.3', 'spread': '0.4', 'groupId': 'OG004'}]}]}, {'title': 'Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '0.6', 'groupId': 'OG003'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG004'}]}]}, {'title': 'Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '0.4', 'groupId': 'OG003'}, {'value': '0.9', 'spread': '1.6', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.4', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '0.5', 'groupId': 'OG003'}, {'value': '0.3', 'spread': '0.7', 'groupId': 'OG004'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '0.6', 'groupId': 'OG003'}, {'value': '0.3', 'spread': '0.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.4', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.1', 'groupId': 'OG003'}, {'value': '0.3', 'spread': '0.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '0.8', 'groupId': 'OG003'}, {'value': '0.3', 'spread': '0.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.1', 'groupId': 'OG003'}, {'value': '0.3', 'spread': '0.4', 'groupId': 'OG004'}]}]}, {'title': 'Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.1', 'groupId': 'OG003'}, {'value': '0.3', 'spread': '0.3', 'groupId': 'OG004'}]}]}, {'title': 'Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.5', 'groupId': 'OG002'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG003'}, {'value': '0.5', 'spread': '0.6', 'groupId': 'OG004'}]}]}, {'title': 'Week 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG003'}, {'value': '0.5', 'spread': '0.6', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.1', 'groupId': 'OG003'}, {'value': '0.3', 'spread': '0.3', 'groupId': 'OG004'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.4', 'groupId': 'OG002'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '0.1', 'groupId': 'OG004'}]}]}, {'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG003'}]}]}, {'title': 'Week 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.1', 'groupId': 'OG003'}, {'value': '0.4', 'spread': '0.4', 'groupId': 'OG004'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '0.2', 'groupId': 'OG004'}]}]}, {'title': 'Week 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '0.2', 'groupId': 'OG004'}]}]}, {'title': 'Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '0.1', 'groupId': 'OG004'}]}]}, {'title': 'Week 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '0.1', 'groupId': 'OG004'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.3', 'groupId': 'OG004'}]}]}, {'title': 'Week 33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.2', 'groupId': 'OG004'}]}]}, {'title': 'Week 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.3', 'groupId': 'OG004'}]}]}, {'title': 'Week 35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '0.6', 'spread': '0.9', 'groupId': 'OG003'}, {'value': '0.4', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.2', 'groupId': 'OG004'}]}]}, {'title': 'Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.3', 'groupId': 'OG004'}]}]}, {'title': 'Week 38', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.1', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '0.4', 'groupId': 'OG002'}, {'value': '0.3', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG003'}, {'value': '0.3', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '0.4', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.2', 'groupId': 'OG004'}]}]}, {'title': 'Week 41', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '0.4', 'groupId': 'OG004'}]}]}, {'title': 'Week 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG001'}, {'value': '0.3', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.5', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG001'}, {'value': '0.6', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG003'}, {'value': '0.4', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '0.7', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '0.4', 'groupId': 'OG004'}]}]}, {'title': 'Week 46', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.1', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG001'}, {'value': '0.2', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.5', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 47', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG001'}, {'value': '0.1', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.8', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '0.6', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '0.4', 'groupId': 'OG004'}]}]}, {'title': 'Week 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.1', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG001'}, {'value': '0.2', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.5', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG001'}, {'value': '0.2', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.5', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '0.2', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.5', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 53', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '0.2', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.3', 'groupId': 'OG004'}]}]}, {'title': 'Week 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG001'}, {'value': '0.2', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.5', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 55', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.2', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG001'}, {'value': '0.2', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.5', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.2', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '2.1', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.3', 'groupId': 'OG004'}]}]}, {'title': 'Week 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.6', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 59', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG001'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.6', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Week 61', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '2.1', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '0.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 62', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.6', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 63', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG001'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.8', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG000'}, {'value': '1.1', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '0.7', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.8', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 67', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.9', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '1.2', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 69', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '2.1', 'groupId': 'OG002'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 70', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '1.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.8', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG001'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.9', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 73', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.8', 'groupId': 'OG002'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 74', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.8', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '1.1', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.6', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 77', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.9', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG000'}, {'value': '1.4', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Week 79', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.8', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG000'}, {'value': '1.1', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.8', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 81', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Week 82', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Week 83', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.8', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG000'}, {'value': '0.6', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Week 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.6', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 86', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG000'}, {'value': '0.6', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.6', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 89', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG000'}, {'value': '0.7', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 92', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 93', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 94', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.7', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.7', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.8', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 97', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 98', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.7', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 99', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.7', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.7', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 101', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 102', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.7', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 103', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.7', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.7', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 105', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG002'}, {'value': '0.8', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 107', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': 'NA', 'comment': 'SD is not evaluable when only one participant is analyzed', 'groupId': 'OG004'}]}]}, {'title': 'End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '0.8', 'spread': '1.0', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '0.2', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Every week during treatment (up to 24 weeks) and for the first 2 months after treatment, thereafter every month for 10 months or until withdrawal (up to 18 months overall)', 'description': 'The TINAS is an 11-item questionnaire that assesses the severity of neuropathy-related symptoms in the last 24 hours. The 11 items assessed were: hot/burning sensations in hands/feet, sensations pins and needles arms/legs, numbness or tingling in hands/feet, sensations of electric shock, pain when touching cold things, cramps in hands/feet, discomfort when touching things, discomfort skin contact with something, trouble grasping small objects, trouble walking loss feeling legs/feet, difficulty balance loss feeling leg/feet. Each item was scored on a 0-10 scale, with 0 being the symptom is not present, and 10 being the symptom is as bad as the participant can imagine. Higher scores indicate more severe disease. Scores were averaged at each week.', 'unitOfMeasure': 'Points on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all randomized participants in Arms A-F (Phase II) irrespective of whether or not they received the study treatment. 'Overall Number Analysed' =number of participants with data available for analysis. 'Number of Participants Analyzed'=number of participants evaluable for this outcome measure. Participants from Arm F did not answer a sufficient number of questions at both baseline and end of treatment visit therefore the average score could not be calculated."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 milligrams per kilogram (mg/kg), as intravenous (IV) infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 milligrams per meter-squared (mg/m\\^2), as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'FG001', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'FG002', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'FG003', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'FG004', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'FG005', 'title': 'Arm B (Phase II Randomization): BR in FL', 'description': 'Participants with FL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'FG006', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'FG007', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'FG008', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'FG009', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'FG010', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '39'}, {'groupId': 'FG005', 'numSubjects': '41'}, {'groupId': 'FG006', 'numSubjects': '40'}, {'groupId': 'FG007', 'numSubjects': '40'}, {'groupId': 'FG008', 'numSubjects': '20'}, {'groupId': 'FG009', 'numSubjects': '21'}, {'groupId': 'FG010', 'numSubjects': '106'}]}, {'type': 'Safety Population', 'comment': 'Safety population was defined as all participants who have received at least one dose of study medication.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '38'}, {'groupId': 'FG005', 'numSubjects': '41'}, {'groupId': 'FG006', 'numSubjects': '39'}, {'groupId': 'FG007', 'numSubjects': '39'}, {'groupId': 'FG008', 'numSubjects': '20'}, {'groupId': 'FG009', 'numSubjects': '20'}, {'groupId': 'FG010', 'numSubjects': '106'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '22'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '16'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '19'}, {'groupId': 'FG005', 'numSubjects': '19'}, {'groupId': 'FG006', 'numSubjects': '34'}, {'groupId': 'FG007', 'numSubjects': '38'}, {'groupId': 'FG008', 'numSubjects': '4'}, {'groupId': 'FG009', 'numSubjects': '21'}, {'groupId': 'FG010', 'numSubjects': '76'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '26'}, {'groupId': 'FG007', 'numSubjects': '30'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '18'}, {'groupId': 'FG010', 'numSubjects': '65'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}]}, {'type': 'Not treated/Per Sponsor Participant Could not Continue/Pathology Showed Transformation: Cycle 1Day 1', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'A total of 331 participants with relapsed or refractory (R/R) follicular lymphoma (FL) or diffuse large B cell lymphoma (DLBCL) were enrolled in this study at 56 investigative sites in the following countries: Australia, Canada, Czech Republic, France, Germany, Hungary, Italy, Korea, the Netherlands, Spain, Turkey, United Kingdom, and the United States from 15 October 2014 to 21 October 2021.', 'preAssignmentDetails': 'Participants were enrolled in Phase Ib and Phase II to receive polatuzumab vedotin (pola) (liquid formulation in randomized \\& expansion stages; lyophilized formulation in new formulation (NF) cohorts) in combination with standard doses of bendamustine (B) \\& rituximab (R)/obinutuzumab (G). Out of 331 participants, 327 participants received at least one dose of study drug and their intended treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}, {'value': '41', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}, {'value': '40', 'groupId': 'BG007'}, {'value': '20', 'groupId': 'BG008'}, {'value': '21', 'groupId': 'BG009'}, {'value': '106', 'groupId': 'BG010'}, {'value': '331', 'groupId': 'BG011'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'BG001', 'title': 'Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'BG002', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'BG003', 'title': 'Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'BG004', 'title': 'Arm A (Phase II Randomization): Pola+BR in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'BG005', 'title': 'Arm B (Phase II Randomization): BR in FL', 'description': 'Participants with FL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'BG006', 'title': 'Arm C (Phase II Randomization): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'BG007', 'title': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.'}, {'id': 'BG008', 'title': 'Arm E (Phase II Expansion): Pola+BG in FL', 'description': 'Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'BG009', 'title': 'Arm F (Phase II Expansion): Pola+BG in DLBCL', 'description': 'Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.'}, {'id': 'BG010', 'title': 'Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL', 'description': 'Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.'}, {'id': 'BG011', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.0', 'groupId': 'BG000', 'lowerLimit': '54', 'upperLimit': '73'}, {'value': '65.0', 'groupId': 'BG001', 'lowerLimit': '58', 'upperLimit': '79'}, {'value': '63.5', 'groupId': 'BG002', 'lowerLimit': '42', 'upperLimit': '73'}, {'value': '71.0', 'groupId': 'BG003', 'lowerLimit': '53', 'upperLimit': '84'}, {'value': '65.0', 'groupId': 'BG004', 'lowerLimit': '37', 'upperLimit': '74'}, {'value': '63.0', 'groupId': 'BG005', 'lowerLimit': '39', 'upperLimit': '80'}, {'value': '67.0', 'groupId': 'BG006', 'lowerLimit': '33', 'upperLimit': '86'}, {'value': '71.0', 'groupId': 'BG007', 'lowerLimit': '30', 'upperLimit': '84'}, {'value': '60.5', 'groupId': 'BG008', 'lowerLimit': '37', 'upperLimit': '86'}, {'value': '65.0', 'groupId': 'BG009', 'lowerLimit': '26', 'upperLimit': '86'}, {'value': '70.0', 'groupId': 'BG010', 'lowerLimit': '24', 'upperLimit': '94'}, {'value': '67.0', 'groupId': 'BG011', 'lowerLimit': '24', 'upperLimit': '94'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '15', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}, {'value': '10', 'groupId': 'BG009'}, {'value': '54', 'groupId': 'BG010'}, {'value': '151', 'groupId': 'BG011'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '28', 'groupId': 'BG006'}, {'value': '25', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}, {'value': '11', 'groupId': 'BG009'}, {'value': '52', 'groupId': 'BG010'}, {'value': '180', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '30', 'groupId': 'BG011'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '33', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}, {'value': '31', 'groupId': 'BG007'}, {'value': '16', 'groupId': 'BG008'}, {'value': '15', 'groupId': 'BG009'}, {'value': '83', 'groupId': 'BG010'}, {'value': '259', 'groupId': 'BG011'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '14', 'groupId': 'BG010'}, {'value': '34', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '14', 'groupId': 'BG011'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '34', 'groupId': 'BG005'}, {'value': '35', 'groupId': 'BG006'}, {'value': '36', 'groupId': 'BG007'}, {'value': '16', 'groupId': 'BG008'}, {'value': '19', 'groupId': 'BG009'}, {'value': '87', 'groupId': 'BG010'}, {'value': '285', 'groupId': 'BG011'}]}, {'title': 'Not Stated', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '13', 'groupId': 'BG010'}, {'value': '22', 'groupId': 'BG011'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '10', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) population included all participants who were randomized, whether or not the participants received the assigned treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-23', 'size': 3246884, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-10-18T05:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 331}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-18', 'studyFirstSubmitDate': '2014-10-02', 'resultsFirstSubmitDate': '2022-10-18', 'studyFirstSubmitQcDate': '2014-10-03', 'lastUpdatePostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-18', 'studyFirstPostDateStruct': {'date': '2014-10-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase Ib: Percentage of Participants With Adverse Events (AEs)', 'timeFrame': 'From the study start up to the end of the study (up to approximately 84 months)', 'description': 'An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 4.0 (NCI-CTCAE, v4.0).'}, {'measure': 'Arm G+H (Phase II NF Cohort): Percentage of Participants With AEs', 'timeFrame': 'From Month 37 to Month 84 (up to approximately 47 months)', 'description': 'An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the NCI-CTCAE, v4.0. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.'}, {'measure': 'Cohort 1a (Phase Ib): Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Polatuzumab Vedotin', 'timeFrame': 'Baseline up to approximately Month 24', 'description': 'The number of participants with positive results for ADA against pola at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = 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 titer unit (t.u.) greater than the baseline titer result. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.'}, {'measure': 'Cohort 1b (Phase Ib): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab', 'timeFrame': 'Baseline up to approximately Month 24', 'description': 'The number of participants with positive results for ADA against pola and obinutuzumab at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = 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. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.'}, {'measure': 'Arms G+H: (Phase II NF Cohorts): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin (Lyophilized)', 'timeFrame': 'From Month 37 to Month 84 (up to approximately 47 months)', 'description': 'The number of participants with positive results for ADA against lyophilized pola at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = 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. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.'}, {'measure': 'Phase II Randomized and NF Cohorts: Percentage of Participants With Complete Response (CR) at Primary Response Assessment (PRA) Based on Positron Emission Tomography (PET)-Computed Tomography (CT) Scan as Determined by Independent Review Committee (IRC)', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)', 'description': 'CR was assessed by IRC at PRA according to Modified Lugano Response Criteria (MLRC). Per MLRC, CR based on PET-CT was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites (ELS) with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS) where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \\> mediastinum but ≤ liver; 4=uptake moderately \\> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, immunohistochemistry (IHC) negative. As pre-specified in the protocol data reported is combined for Arms G and H. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number.'}, {'measure': 'Arm H (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on PET-CT as Determined by the IRC', 'timeFrame': '6-8 weeks after Cycle 6, Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)', 'description': 'CR was assessed by IRC at PRA according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \\> mediastinum but ≤ liver; 4=uptake moderately \\> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number.'}, {'measure': 'Arm G (Phase II NF Cohort): Area Under Concentration-Time Curve (AUC) of Polatuzumab Vedotin (Lyophilized)', 'timeFrame': 'Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (each cycle is 21 days DLBCL cohorts) up to approximately 9 weeks', 'description': 'Pharmacokinetic (PK) of three pola-related analytes: antibody conjugated monomethyl auristatin E (acMMAE), total antibody, and unconjugated MMAE were measured. The unit of measure for AUC is nanograms\\*day per milliliters.'}, {'measure': 'Arm G (Phase II NF Cohort): Maximum Concentration (Cmax) of Polatuzumab Vedotin (Lyophilized)', 'timeFrame': 'Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4,(cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.'}, {'measure': 'Arm G (Phase II NF Cohort): Systemic Clearance (CL) of Polatuzumab Vedotin (Lyophilized)', 'timeFrame': 'Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured. Unit of measure for CL is milliliters per day per kilograms (mL/day/kg)'}, {'measure': 'Arm G (Phase II NF Cohort): Steady-State Volume of Distribution (Vss) of Polatuzumab Vedotin (Lyophilized)', 'timeFrame': 'Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, Day (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.'}], 'secondaryOutcomes': [{'measure': 'Phase II: Percentage of Participants With AEs', 'timeFrame': 'From the study start up to the end of the study (up to approximately 84 months)', 'description': 'An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the NCI-CTCAE, v4.0. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.'}, {'measure': 'Arms A and C (Phase II): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin', 'timeFrame': 'Baseline to approximately Month 24', 'description': 'The number of participants with positive results for ADA against pola at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = 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. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.'}, {'measure': 'Arms E and F (Phase II): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab', 'timeFrame': 'Baseline to approximately Month 24', 'description': 'The number of participants with positive results for ADA against pola and obinutuzumab at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = 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. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.'}, {'measure': 'Phase II: Percentage of Participants With CR at PRA Based on PET-CT as Determined by the Investigator', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)', 'description': 'CR was assessed by investigator at PRA according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \\> mediastinum but ≤ liver; 4=uptake moderately \\> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts) or after final dose of study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.'}, {'measure': 'Phase II Expansion Cohorts and Arm G (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on PET-CT as Determined by the IRC', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)', 'description': 'CR was assessed by IRC at PRA according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \\> mediastinum but ≤ liver; 4=uptake moderately \\> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number.'}, {'measure': 'Phase II: Percentage of Participants With Objective Response (OR) at PRA Based on PET-CT as Determined by Investigator', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)', 'description': 'OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the investigator according to MLRC. Per MLRC, CR based on PET-CT complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass on 5PS, where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake mediastinum but ≤ liver; 4=uptake moderately \\> liver; 5=uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of FDG-avid disease in bone marrow, normal by morphology; if indeterminate, IHC negative. PR based on PET-CT was defined as partial MR in lymph nodes and ELS with a score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size at interim, residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed).'}, {'measure': 'Phase II: Percentage of Participants With OR at PRA Based on PET-CT as Determined by IRC', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)', 'description': 'OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the IRC according to MLRC. Per MLRC, CR based on PET-CT= complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass on 5PS, where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake mediastinum but ≤ liver; 4=uptake moderately \\> liver; 5=uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of FDG-avid disease in bone marrow. Bone marrow normal by morphology; if indeterminate, IHC negative. PR based on PET-CT was defined as partial MR in lymph nodes and ELS with a score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size at interim, residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed).'}, {'measure': 'Phase II: Percentage of Participants With CR at PRA Based on CT Only as Determined by Investigator', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)', 'description': 'CR was determined by investigator at PRA according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 centimetres (cm) in in longest transverse diameter (LDi) and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts). As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.'}, {'measure': 'Phase II: Percentage of Participants With CR at PRA Based on CT Only as Determined by IRC', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)', 'description': 'CR was determined by IRC a at PRA according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts). As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.'}, {'measure': 'Phase II: Percentage of Participants With OR at PRA Based on CT Only as Determined by Investigator', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)', 'description': 'OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the investigator based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in sum of the products of greatest diameters (SPD) of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts).'}, {'measure': 'Phase II: Percentage of Participants With OR at PRA Based on CT Only as Determined by IRC', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)', 'description': 'OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the IRC based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease SPD of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts).'}, {'measure': 'Phase II: Percentage of Participants With Best Objective Response (BOR) Based on PET-CT or CT Only as Determined by the Investigator', 'timeFrame': 'Up to every 6 months until disease progression, withdrawal or study completion (up to approximately 84 months)', 'description': 'BOR=CR/PR per PET-CT/CT per MLRC.CR per PET-CT=complete MR in LN \\& ELS, score=1, 2,3 with/without a residual mass on 5-PS; 1=no uptake(UT) above background;2=UT≤mediastinum;3=UT\\>mediastinum but ≤liver;4=UT moderately\\>liver;5=UT markedly higher than liver \\&/or new lesions;no evidence of FDG-avid disease, bone marrow morphology=normal;if indeterminate, is IHC negative.PR per PET-CT=partial MR in LN \\& ELS, score=4 or 5, reduced UT than baseline (BL) \\& residual mass of any size;residual UT\\>UT in normal marrow but reduced than BL.CR per CT=complete radiologic response with target nodes/nodal masses regressed to ≤1.5cm in LDi \\& no ELS of disease, absences of non-measured lesion;organ enlargement regressed to normal;no new lesions;bone marrow= normal;if indeterminate, is IHC negative.PR per CT=≥50% decrease in SPD of up to 6 target nodes \\& extranodal sites;non-measured lesions=absent/normal/regressed/no increase;spleen=regressed by ≥50% in length beyond normal, no new lesions.'}, {'measure': 'DLBCL Cohorts: Percentage of Participants With BOR Based PET-CT or CT Only as Determined by IRC', 'timeFrame': 'Up to every 6 months until disease progression, withdrawal or study completion (up to approximately 84 months)', 'description': 'BOR=CR/PR per PET-CT/CT per MLRC.CR per PET-CT=complete MR in LN \\& ELS, score=1, 2,3 with/without a residual mass on 5-PS; 1=no uptake(UT) above background;2=UT≤mediastinum;3=UT\\>mediastinum but ≤liver;4=UT moderately\\>liver;5=UT markedly higher than liver \\&/or new lesions;no evidence of FDG-avid disease, bone marrow morphology=normal;if indeterminate, is IHC negative.PR per PET-CT=partial MR in LN \\& ELS, score=4 or 5, reduced UT than baseline (BL) \\& residual mass of any size;residual UT\\>UT in normal marrow but reduced than BL.CR per CT=complete radiologic response with target nodes/nodal masses regressed to ≤1.5cm in LDi \\& no ELS of disease, absences of non-measured lesion;organ enlargement regressed to normal;no new lesions;bone marrow= normal;if indeterminate, is IHC negative.PR per CT=≥50% decrease in SPD of up to 6 target nodes \\& extranodal sites;non-measured lesions=absent/normal/regressed/no increase;spleen=regressed by ≥50% in length beyond normal, no new lesions.'}, {'measure': 'DLBCL Cohorts: Duration of Response (DOR) Based on PET-CT or CT Only as Determined by the Investigator', 'timeFrame': 'From the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse, or death from any cause whichever occur first (up to approximately 84 months)', 'description': 'DOR=first occurrence of CR/PR to disease progression/relapse/death per PET-CT/CT, per investigator per MLRC.CR per PET-CT=score 1/2/3 with/without a residual mass on 5-PS for LN and ELS;1=no UT\\> background; 2=UT≤mediastinum;3=UT\\>mediastinum but ≤liver;4=UT moderately\\>liver;5=UT\\>than liver \\&/or new lesions;bone marrow morphology=no evidence of FDG-avid disease, normal;if indeterminate IHC negative.PR per PET-CT=score of 4/5 with reduced UT compared to BL \\& residual mass of any size at interim for LN \\& ELS;residual UT\\>UT in normal bone marrow but\\<than BL. CR per CT=target nodes/nodal masses regressed to ≤1.5cm in LDi no ELS of disease for LN \\& ELS, no non-measured lesion, organ enlargement regressed to normal; bone marrow=normal morphology; if indeterminate, IHC negative. PR per CT= ≥50% decrease SPD of 6 target measurable LN and extranodal sites, absent/normal/regressed but no increase in non-measured lesions, spleen ≥50% in length beyond normal involvement, no new sites of lesions.'}, {'measure': 'DLBCL Cohorts: DOR Based on PET-CT or CT Only as Determined by the IRC', 'timeFrame': 'From the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse, or death from any cause whichever occur first (up to approximately 84 months)', 'description': 'DOR=first occurrence of CR/PR to disease progression/relapse/death per PET-CT/CT, per IRC per MLRC.CR per PET-CT=score 1/2/3 with/without a residual mass on 5-PS for LN and ELS;1=no UT\\> background; 2=UT≤mediastinum;3=UT\\>mediastinum but ≤liver;4=UT moderately\\>liver;5=UT\\>than liver \\&/or new lesions;bone marrow morphology=no evidence of FDG-avid disease, normal;if indeterminate IHC negative.PR per PET-CT=score of 4/5 with reduced UT compared to BL \\& residual mass of any size at interim for LN \\& ELS;residual UT\\>UT in normal bone marrow but\\<than BL. CR per CT=target nodes/nodal masses regressed to ≤1.5cm in LDi no ELS of disease for LN \\& ELS, no non-measured lesion, organ enlargement regressed to normal; bone marrow=normal morphology; if indeterminate, IHC negative. PR per CT= ≥50% decrease SPD of 6 target measurable LN and extranodal sites, absent/normal/regressed but no increase in non-measured lesions, spleen ≥50% in length beyond normal involvement, no new sites of lesions.'}, {'measure': 'DLBCL Cohorts: Progression Free Survival (PFS) Based on PET-CT or CT Only as Determined by the Investigator', 'timeFrame': 'From the date of randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (up to approximately 84 months)', 'description': 'PFS was defined as the time randomization or from first study treatment (for obinuzumab arms) to the first occurrence of disease progression, relapse or death, from any cause based on PET-CT or CT only, as determined by the investigators assessment. As pre-specified in the protocol data reported is combined for Arms G and H.'}, {'measure': 'DLBCL Cohorts: PFS Based on PET-CT or CT Only as Determined by the IRC', 'timeFrame': 'From the date of randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (up to approximately 84 months)', 'description': 'PFS was defined as the time randomization or from first study treatment (for obinuzumab arms) to the first occurrence of disease progression, relapse or death, from any cause based on PET-CT or CT only, as determined by the IRC assessment. As pre-specified in the protocol data reported is combined for Arms G and H.'}, {'measure': 'Phase II NF Cohort: Percentage of Participants With CR at PRA Based on PET-CT as Determined by the Investigator', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)', 'description': 'CR was assessed by Investigator at PRA according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \\> mediastinum but ≤ liver; 4=uptake moderately \\> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. As pre-specified in the protocol data reported is combined for Arms G and H. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number.'}, {'measure': 'Phase II NF Cohort: Percentage of Participants With OR at PRA Based on PET-CT as Determined by Investigator', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)', 'description': 'OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the investigator according to MLRC. Per MLRC, CR based on PET-CT= complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass on 5PS, where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake mediastinum but ≤ liver; 4=uptake moderately\\>liver; 5=uptake markedly higher than liver and/or new lesions ; no new lesions and no evidence of FDG-avid disease in bone marrow, normal by morphology; if indeterminate, IHC negative. PR based on PET-CT was defined as partial MR in lymph nodes and ELS with a score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size at interim, residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed).'}, {'measure': 'Phase II NF Cohort: Percentage of Participants With OR at PRA Based on PET-CT as Determined by IRC', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)', 'description': 'OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the IRC according to MLRC. Per MLRC, CR based on PET-CT= complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass on 5PS, where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake mediastinum but ≤ liver; 4=uptake moderately \\> liver; 5=uptake markedly higher than liver and/or new lesions ; no new lesions and no evidence of FDG-avid disease in bone marrow, bone marrow normal by morphology; if indeterminate, IHC negative. PR based on PET-CT was defined as partial MR in lymph nodes and ELS with a score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size at interim, residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed).'}, {'measure': 'Phase II NF Cohorts: Percentage of Participants With BOR Based on PET-CT or CT Only as Determined by the Investigator', 'timeFrame': 'Up to every 6 months until disease progression, withdrawal or study completion (from Month 37 to Month 84 [up to approximately 47 months])', 'description': 'BOR=CR/PR per PET-CT/CT per MLRC. CR per PET-CT=complete MR in lymph nodes \\& ELS, score=1, 2,3 with/without a residual mass on 5-PS; 1=no UT above background; 2=UT≤mediastinum;3=UT\\>mediastinum but ≤liver;4=UT moderately\\>liver;5=UT markedly higher than liver \\&/or new lesions;no evidence of FDG-avid disease, bone marrow morphology=normal;if indeterminate, is IHC negative.PR per PET-CT=partial MR in lymph nodes \\& ELS, score=4 or 5, reduced UT than BL \\& residual mass of any size;residual UT\\>UT in normal marrow but reduced than BL.CR per CT=complete radiologic response with target nodes/nodal masses regressed to ≤1.5cm in LDi \\& no ELS of disease, absences of non-measured lesion;organ enlargement regressed to normal;no new lesions;bone marrow= normal;if indeterminate, is IHC negative.PR per CT=≥50% decrease in SPD of up to 6 target nodes \\& extranodal sites;non-measured lesions=absent/normal/regressed/no increase;spleen=regressed by ≥50% in length beyond normal, no new lesions.'}, {'measure': 'Phase II NF Cohorts: Percentage of Participants With BOR Based on PET-CT or CT Only as Determined by the IRC', 'timeFrame': 'Up to every 6 months until disease progression, withdrawal or study completion (from Month 37 to Month 84 [up to approximately 47 months])', 'description': 'BOR=CR/PR per PET-CT/CT per MLRC. CR per PET-CT=complete MR in lymph nodes \\& ELS, score=1, 2,3 with/without a residual mass on 5-PS; 1=no UT above background; 2=UT≤mediastinum;3=UT\\>mediastinum but ≤liver;4=UT moderately\\>liver;5=UT markedly higher than liver \\&/or new lesions;no evidence of FDG-avid disease, bone marrow morphology=normal;if indeterminate, is IHC negative.PR per PET-CT=partial MR in lymph nodes \\& ELS, score=4 or 5, reduced UT than BL \\& residual mass of any size;residual UT\\>UT in normal marrow but reduced than BL.CR per CT=complete radiologic response with target nodes/nodal masses regressed to ≤1.5cm in LDi \\& no ELS of disease, absences of non-measured lesion;organ enlargement regressed to normal;no new lesions;bone marrow= normal;if indeterminate, is IHC negative.PR per CT=≥50% decrease in SPD of up to 6 target nodes \\& extranodal sites;non-measured lesions=absent/normal/regressed/no increase;spleen=regressed by ≥50% in length beyond normal, no new lesions.'}, {'measure': 'Phase II NF Cohort: DOR Based on PET-CT or CT Only as Determined by the Investigator', 'timeFrame': 'From the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse, or death from any cause whichever occur first (from Month 37 to Month 84 [up to approximately 47 months])', 'description': 'DOR=first occurrence of CR/PR to disease progression/relapse/death per PET-CT/CT, per investigator per MLRC.CR per PET-CT=score 1/2/3 with/without a residual mass on 5-PS for LN and ELS;1=no UT\\> background; 2=UT≤mediastinum;3=UT\\>mediastinum but ≤liver;4=UT moderately\\>liver;5=UT\\>than liver \\&/or new lesions;bone marrow morphology=no evidence of FDG-avid disease, normal;if indeterminate IHC negative.PR per PET-CT=score of 4/5 with reduced UT compared to BL \\& residual mass of any size at interim for LN \\& ELS;residual UT\\>UT in normal bone marrow but\\<than BL. CR per CT=target nodes/nodal masses regressed to ≤1.5cm in LDi no ELS of disease for LN \\& ELS, no non-measured lesion, organ enlargement regressed to normal; bone marrow=normal morphology; if indeterminate, IHC negative. PR per CT= ≥50% decrease SPD of 6 target measurable LN and extranodal sites, absent/normal/regressed but no increase in non-measured lesions, spleen ≥50% in length beyond normal involvement, no new sites of lesions.'}, {'measure': 'Phase II NF Cohort: DOR Based on PET-CT or CT Only as Determined by the IRC', 'timeFrame': 'From the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse, or death from any cause whichever occur first (from Month 37 to Month 84 [up to approximately 47 months])', 'description': 'DOR=first occurrence of CR/PR to disease progression/relapse/death per PET-CT/CT, per IRC per MLRC.CR per PET-CT=score 1/2/3 with/without a residual mass on 5-PS for LN and ELS;1=no UT\\> background; 2=UT≤mediastinum;3=UT\\>mediastinum but ≤liver;4=UT moderately\\>liver;5=UT\\>than liver \\&/or new lesions;bone marrow morphology=no evidence of FDG-avid disease, normal;if indeterminate IHC negative.PR per PET-CT=score of 4/5 with reduced UT compared to BL \\& residual mass of any size at interim for LN \\& ELS;residual UT\\>UT in normal bone marrow but\\<than BL. CR per CT=target nodes/nodal masses regressed to ≤1.5cm in LDi no ELS of disease for LN \\& ELS, no non-measured lesion, organ enlargement regressed to normal; bone marrow=normal morphology; if indeterminate, IHC negative. PR per CT= ≥50% decrease SPD of 6 target measurable LN and extranodal sites, absent/normal/regressed but no increase in non-measured lesions, spleen ≥50% in length beyond normal involvement, no new sites of lesions.'}, {'measure': 'Phase II NF Cohort: PFS Based on PET-CT or CT Only as Determined by the Investigator', 'timeFrame': 'From the date of randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (from Month 37 to Month 84 [up to approximately 47 months])', 'description': 'PFS was defined as the time from randomization or from first study treatment (for obinuzumab arms) to the first occurrence of disease progression, relapse or death, from any cause based on PET-CT or CT only, as determined by the investigators assessment. As pre-specified in the protocol data reported is combined for Arms G and H.'}, {'measure': 'Phase II NF Cohort: PFS Based on PET-CT or CT Only as Determined by the IRC', 'timeFrame': 'From the date of randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (from Month 37 to Month 84 [up to approximately 47 months])', 'description': 'PFS was defined as the time from randomization or from first study treatment (for obinuzumab arms) to the first occurrence of disease progression, relapse or death, from any cause based on PET-CT or CT only, as determined by the IRC assessment. As pre-specified in the protocol data reported is combined for Arms G and H.'}, {'measure': 'Phase II NF Cohort: Event-Free Survival (EFS) Based on PET-CT or CT Only, as Determined by the Investigator', 'timeFrame': 'From Month 37 to Month 84 (up to approximately 47 months)', 'description': 'EFS was defined as time from randomization to disease progression or relapse, as assessed by the investigator or death from any cause. As pre-specified in the protocol data reported is combined for Arms G and H.'}, {'measure': 'Phase II NF Cohorts: Overall Survival (OS)', 'timeFrame': 'From Month 37 to Month 84 (up to approximately 47 months)', 'description': 'OS was defined as the time from the date of randomization or first treatment (for obinutuzumab arms) to the date of death from any cause. As pre-specified in the protocol data reported is combined for Arms G and H.'}, {'measure': 'Arm G (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on PET-CT as Determined by the IRC', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)', 'description': 'CR was assessed by IRC at PRA according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \\> mediastinum but ≤ liver; 4=uptake moderately \\> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. As pre-specified in the protocol data reported is combined for Arms G and H. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number.'}, {'measure': 'Arm G (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on CT Only as Determined by Investigator', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)', 'description': 'CR was determined by Investigator at PRA according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts). Values have been rounded off to the nearest whole number.'}, {'measure': 'Arm G (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on CT Only as Determined by IRC', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)', 'description': 'CR was determined by IRC at PRA according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts). Values have been rounded off to the nearest whole number.'}, {'measure': 'Arm G (Phase II NF Cohort): Percentage of Participants With OR at PRA Based on CT Only as Determined by Investigator', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to 23 weeks)', 'description': 'OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the investigator based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in SPD of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts).'}, {'measure': 'Arm G (Phase II NF Cohort): Percentage of Participants With OR at PRA Based on CT Only as Determined by IRC', 'timeFrame': '6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to 23 weeks)', 'description': 'OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the IRC based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in SPD of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts).'}, {'measure': 'Plasma Concentration of of Polatuzumab Vedotin Analyte: acMMAE', 'timeFrame': 'Cycle 1 Day 2: pre-dose and 30 minutes (min) post dose; Cycle 1 Days 8 and 15; Cycle 2 and 4 Day 1: pre-dose and 30 min post dose; unscheduled visits: pre-dose and 30 min post dose; study treatment completion (up to approximately 84 months)', 'description': 'PK of pola-related analyte acMMAE was measured. Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts.'}, {'measure': 'Arm G+H (Phase II NF Cohorts): Plasma Concentration of of Polatuzumab Vedotin Analyte: acMMAE', 'timeFrame': 'Cycle 1 Day 2: post dose; Cycle 2 and 4 Day 1: pre-dose and post dose', 'description': 'PK of one pola-related analytes: acMMAE was measured. Cycle length is 21 days for DLBCL cohorts. As pre-specified in the protocol data is reported combined for arms G+H.'}, {'measure': 'Serum Concentration of of Polatuzumab Vedotin Analyte: Total Ab', 'timeFrame': 'Cycle 1 Days 2: pre-dose & 30 min post dose; Cycle 1 Days 8 & 15; Cycle 2 and 4 Day 1 and unscheduled visits: pre-dose & 30 min post dose; Follow up at Day 1: Months 3, 6, 12, 18 & 24; study treatment completion visit (up to approx. 84 months)', 'description': 'PK of pola-related analyte Total Ab was measured. Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts.'}, {'measure': 'Arm G+H (Phase II NF Cohorts): Plasma Concentration of Polatuzumab Vedotin Analyte: Total Ab', 'timeFrame': 'Cycle 1 Day 2: post dose; Cycle 2 and 4 Day 1: pre-dose and post dose', 'description': 'PK of pola-related analyte: Total Ab was measured. Cycle length is 21 days for DLBCL cohorts. As pre-specified in the protocol data is reported combined for arms G+H.'}, {'measure': 'Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE', 'timeFrame': 'Cycle 1 Day 2: pre-dose and 30 min post dose, Cycle 1 Days 8 and 15; Cycles 2 and 4: pre-dose and 30 min post dose; unscheduled visits: pre-dose and 30 min post dose; study treatment completion (up to approximately 84 months)', 'description': 'PK of pola-related analytes unconjugated MMAE was measured. Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts.'}, {'measure': 'Arm G+H (Phase II NF Cohorts): Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE', 'timeFrame': 'Cycle 1 Day 2: post dose; Cycle 1 and 3 Day 8 and 15; Cycle 2, 3 and 4 Day 1: pre-dose and post dose', 'description': 'PK of one pola-related analytes: Unconjugated MMAE was measured. Cycle length is 21 days for DLBCL cohorts. As pre-specified in the protocol data is reported combined for arms G+H.'}, {'measure': 'Plasma Concentration of Bendamustine', 'timeFrame': 'Cycle 1 Day 2: pre-dose, 5 min, 1 hour (h); 2h, 3h and 4h post dose', 'description': 'Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts. As pre specified in the protocol plasma concentration of bendamustine was not assessed in the Phase II NF Cohort (Arm G+H).'}, {'measure': 'Serum Concentration of Rituximab', 'timeFrame': 'Cycle 1 Days 1: pre-dose and 30 min post dose; Cycle 2 and 4 Day 1: pre-dose; unscheduled visits: pre-dose and 30 min post dose (up to approximately 84 months)', 'description': 'Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts. As pre specified in the protocol serum concentration of rituximab was not assessed in the Phase II NF Cohort (Arm G+H).'}, {'measure': 'Serum Concentration of Obinutuzumab', 'timeFrame': 'Cycles 1 and 4 Days 1: pre-dose and 30 min post dose; Cycle 2 Day1: pre-dose; Follow up visits on Day 1: Months 3, 6, 12, 18 and 24; unscheduled visits: pre-dose and 30 min post dose; study treatment completion (up to approximately 84 months)', 'description': 'Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts.'}, {'measure': 'Phase Ib: Cmax of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a', 'timeFrame': 'Cycles 1, 2 and 4 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.'}, {'measure': 'Phase Ib: Cmax of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b', 'timeFrame': 'Cycles 1, 2 and 4 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.'}, {'measure': 'Phase II: Cmax of Polatuzumab Vedotin, Bendamustine, and Rituximab in Arms A and C', 'timeFrame': 'Cycle 1; Cycle 4 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody and unconjugated MMAE were measured.'}, {'measure': 'Phase II: Cmax of Bendamustine and Rituximab in Arms B and D', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)'}, {'measure': 'Phase II: Cmax of Polatuzumab Vedotin, Obinutuzumab and Bendamustine in Arms E and F', 'timeFrame': 'Cycle 1; Cycle 4 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, unconjugated MMAE and total antibody were measured.'}, {'measure': 'Arm H (Phase II NF Cohort): Cmax of Polatuzumab Vedotin (Lyophilized)', 'timeFrame': 'Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4,(cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.'}, {'measure': 'Phase Ib: AUC From Time Zero to Infinity (AUCinf) of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured. The unit of measure for AUC is day\\*micrograms per milliliter \\[day\\*ug/mL\\]).'}, {'measure': 'Phase Ib: AUCinf of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.'}, {'measure': 'Phase II: AUCinf of Polatuzumab Vedotin, Bendamustine, and Rituximab in Arms A and C', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.'}, {'measure': 'Phase II: AUCinf of Bendamustine and Rituximab in Arms B and D', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)'}, {'measure': 'Phase II: AUCinf of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Arms E and F', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.'}, {'measure': 'Arm H (Phase II NF Cohort): AUC of Polatuzumab Vedotin (Lyophilized)', 'timeFrame': 'Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (each cycle is 21 days DLBCL cohorts) up to approximately 9 weeks', 'description': 'PK of three pola-related analytes: antibody acMMAE, total antibody, and unconjugated MMAE were measured.'}, {'measure': 'Phase Ib: CL of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.'}, {'measure': 'Phase Ib: CL of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.'}, {'measure': 'Phase II: CL of Polatuzumab Vedotin, Bendamustine and Rituximab in Arms A and C', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.'}, {'measure': 'Phase II: CL of Bendamustine and Rituximab in Arms B and D', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)'}, {'measure': 'Phase II: CL of Polatuzumab Vedotin, Bendamustine and Obinutuzumab in Arms E and F', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.'}, {'measure': 'Arm H (Phase II NF Cohort): CL of Polatuzumab Vedotin (Lyophilized)', 'timeFrame': 'Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.'}, {'measure': 'Phase Ib: Vss of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1a', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.'}, {'measure': 'Phase Ib: Vss of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.'}, {'measure': 'Phase II: Vss of Polatuzumab Vedotin, Bendamustine and Rituximab in Arms A and C', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.'}, {'measure': 'Phase II: Vss of Bendamustine and Rituximab in Arms B and D', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)'}, {'measure': 'Phase II: Vss of Polatuzumab Vedotin, Bendamustine and Obinutuzumab in Arms E and F', 'timeFrame': 'Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.'}, {'measure': 'Arm H (Phase II NF Cohort): Vss of Polatuzumab Vedotin (Lyophilized)', 'timeFrame': 'Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, Day (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks', 'description': 'PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.'}, {'measure': 'Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F', 'timeFrame': 'Every week during treatment (up to 24 weeks) and for the first 2 months after treatment, thereafter every month for 10 months or until withdrawal (up to 18 months overall)', 'description': 'The TINAS is an 11-item questionnaire that assesses the severity of neuropathy-related symptoms in the last 24 hours. The 11 items assessed were: hot/burning sensations in hands/feet, sensations pins and needles arms/legs, numbness or tingling in hands/feet, sensations of electric shock, pain when touching cold things, cramps in hands/feet, discomfort when touching things, discomfort skin contact with something, trouble grasping small objects, trouble walking loss feeling legs/feet, difficulty balance loss feeling leg/feet. Each item was scored on a 0-10 scale, with 0 being the symptom is not present, and 10 being the symptom is as bad as the participant can imagine. Higher scores indicate more severe disease. Scores were averaged at each week.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphoma']}, 'referencesModule': {'references': [{'pmid': '38843483', 'type': 'DERIVED', 'citation': 'Jemaa S, Ounadjela S, Wang X, El-Galaly TC, Kostakoglu L, Knapp A, Ku G, Musick L, Sahin D, Wei MC, Yin S, Bengtsson T, De Crespigny A, Carano RAD. Automated Lugano Metabolic Response Assessment in 18F-Fluorodeoxyglucose-Avid Non-Hodgkin Lymphoma With Deep Learning on 18F-Fluorodeoxyglucose-Positron Emission Tomography. J Clin Oncol. 2024 Sep 1;42(25):2966-2977. doi: 10.1200/JCO.23.01978. Epub 2024 Jun 6.'}, {'pmid': '37981564', 'type': 'DERIVED', 'citation': 'Bosch F, Kuruvilla J, Vassilakopoulos TP, Maio DD, Wei MC, Zumofen MB, Nastoupil LJ. Indirect Treatment Comparisons of Mosunetuzumab With Third- and Later-Line Treatments for Relapsed/Refractory Follicular Lymphoma. Clin Lymphoma Myeloma Leuk. 2024 Feb;24(2):105-121. doi: 10.1016/j.clml.2023.09.007. Epub 2023 Sep 28.'}, {'pmid': '35086141', 'type': 'DERIVED', 'citation': 'Herrera AF, Tracy S, Croft B, Opat S, Ray J, Lovejoy AF, Musick L, Paulson JN, Sehn LH, Jiang Y. Risk profiling of patients with relapsed/refractory diffuse large B-cell lymphoma by measuring circulating tumor DNA. Blood Adv. 2022 Mar 22;6(6):1651-1660. doi: 10.1182/bloodadvances.2021006415.'}, {'pmid': '34749395', 'type': 'DERIVED', 'citation': 'Sehn LH, Hertzberg M, Opat S, Herrera AF, Assouline S, Flowers CR, Kim TM, McMillan A, Ozcan M, Safar V, Salles G, Ku G, Hirata J, Chang YM, Musick L, Matasar MJ. Polatuzumab vedotin plus bendamustine and rituximab in relapsed/refractory DLBCL: survival update and new extension cohort data. Blood Adv. 2022 Jan 25;6(2):533-543. doi: 10.1182/bloodadvances.2021005794.'}, {'pmid': '33028076', 'type': 'DERIVED', 'citation': 'Betts KA, Thuresson PO, Felizzi F, Du EX, Dieye I, Li J, Schulz M, Masaquel AS. US cost-effectiveness of polatuzumab vedotin, bendamustine and rituximab in diffuse large B-cell lymphoma. J Comp Eff Res. 2020 Oct;9(14):1003-1015. doi: 10.2217/cer-2020-0057. Epub 2020 Oct 8.'}, {'pmid': '32770353', 'type': 'DERIVED', 'citation': 'Shi R, Lu T, Ku G, Ding H, Saito T, Gibiansky L, Agarwal P, Li X, Jin JY, Girish S, Miles D, Li C, Lu D. Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2020 Sep;86(3):347-359. doi: 10.1007/s00280-020-04119-8. Epub 2020 Aug 8.'}, {'pmid': '32705923', 'type': 'DERIVED', 'citation': 'Lu T, Gibiansky L, Li X, Li C, Shi R, Agarwal P, Hirata J, Miles D, Chanu P, Girish S, Jin JY, Lu D. Exposure-safety and exposure-efficacy analyses of polatuzumab vedotin in patients with relapsed or refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 2020 Dec;61(12):2905-2914. doi: 10.1080/10428194.2020.1795154. Epub 2020 Jul 24.'}, {'pmid': '31693429', 'type': 'DERIVED', 'citation': 'Sehn LH, Herrera AF, Flowers CR, Kamdar MK, McMillan A, Hertzberg M, Assouline S, Kim TM, Kim WS, Ozcan M, Hirata J, Penuel E, Paulson JN, Cheng J, Ku G, Matasar MJ. Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2020 Jan 10;38(2):155-165. doi: 10.1200/JCO.19.00172. Epub 2019 Nov 6.'}]}, 'descriptionModule': {'briefSummary': 'This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with standard doses of bendamustine (B) and rituximab (R) or obinutuzumab (G) in participants with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). The study comprises two stages: a Phase Ib safety run-in stage and a Phase II stage. The anticipated time on treatment is 18 weeks for participants with DLBCL and 24 weeks for participants with FL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed relapsed or refractory FL (Grades 1, 2, or 3a) or relapsed or refractory DLBCL\n* If the participant has received prior bendamustine, response duration must have been greater than (\\>) 1 year (for participants who have relapse disease after a prior regimen)\n* At least one bi-dimensionally measurable lesion on imaging scan defined as \\>1.5 centimeters (cm) in its longest dimension\n* Confirmed availability of archival or freshly collected tumor tissue\n* The Phase II NF Cohorts (Arms G and H) will be required to submit tissue and pathology report for central pathology review.\n* Life expectancy of at least 24 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Adequate hematological function unless inadequate function is due to underlying disease\n\nExclusion Criteria:\n\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (MAbs, or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products\n* Contraindication to bendamustine, rituximab, or obinutuzumab\n* Prior use of any MAb, radioimmunoconjugate, or antibody-drug conjugate (ADC) within 4 weeks or 5 half-lives before Cycle 1 Day 1\n* Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to Cycle 1 Day 1\n* Ongoing corticosteroid use \\>30 mg per day prednisone or equivalent, for purposes other than lymphoma symptom control\n* Completion of autologous stem cell transplant (SCT) within 100 days prior to Cycle 1 Day 1\n* Prior allogeneic SCT\n* Eligibility for autologous SCT\n* Grade 3b FL\n* History of transformation of indolent disease to DLBCL\n* Primary or secondary CNS lymphoma\n* Current Grade \\>1 peripheral neuropathy\n* Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to Cycle 1 Day 1\n* Suspected or latent tuberculosis\n* Positive test results for chronic hepatitis B virus (HBV) infection or for hepatitis C virus (HCV) antibody\n* Known history of human immunodeficiency virus (HIV) seropositive status or known infection with human T-cell leukemia virus 1 (HTLV-1) virus\n* Women who are pregnant or lactating or who intend to become pregnant within a year of the last dose of study treatment in the rituximab cohort or within 18 months of last dose in the obinutuzumab cohort\n* Evidence of laboratory abnormalities in standard renal, hepatic, or coagulation function tests\n* Treatment with chimeric antigen receptor T-cell therapy within 100 days prior to Cycle 1, Day 1'}, 'identificationModule': {'nctId': 'NCT02257567', 'briefTitle': 'A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase IB/II Study Evaluating The Safety, Tolerability and Anti-Tumor Activity of Polatuzumab Vedotin in Combination With Rituximab (R) or Obinutuzumab (G) Plus Bendamustine (B) in Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma', 'orgStudyIdInfo': {'id': 'GO29365'}, 'secondaryIdInfos': [{'id': '2014-001361-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A (Phase II Randomization): Polatuzumab+BR in FL', 'description': 'Polatuzumab vedotin will be administered with bendamustine and rituximab in participants with FL.', 'interventionNames': ['Drug: Bendamustine', 'Drug: Polatuzumab vedotin (Liquid)', 'Drug: Rituximab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B (Phase II Randomization): BR in FL', 'description': 'Bendamustine and rituximab will be administered alone (that is, without polatuzumab vedotin) as a control arm in participants with FL.', 'interventionNames': ['Drug: Bendamustine', 'Drug: Rituximab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C (Phase II Randomization): Polatuzumab+BR in DLBCL', 'description': 'Polatuzumab vedotin will be administered with bendamustine and rituximab in participants with DLBCL.', 'interventionNames': ['Drug: Bendamustine', 'Drug: Polatuzumab vedotin (Liquid)', 'Drug: Rituximab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm D (Phase II Randomization): BR in DLBCL', 'description': 'Bendamustine and rituximab will be administered alone (that is, without polatuzumab vedotin) as a control arm in participants with DLBCL.', 'interventionNames': ['Drug: Bendamustine', 'Drug: Rituximab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm E (Phase II Expansion): Polatuzumab+BG in FL', 'description': 'Polatuzumab vedotin will be administered with bendamustine and obinutuzumab in participants with FL.', 'interventionNames': ['Drug: Bendamustine', 'Drug: Obinutuzumab', 'Drug: Polatuzumab vedotin (Liquid)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm F (Phase II Expansion): Polatuzumab+BG in DLBCL', 'description': 'Polatuzumab vedotin will be administered with bendamustine and obinutuzumab in participants with DLBCL.', 'interventionNames': ['Drug: Bendamustine', 'Drug: Obinutuzumab', 'Drug: Polatuzumab vedotin (Liquid)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in DLBCL', 'description': 'Polatuzumab vedotin will be administered with bendamustine and rituximab in participants with DLBCL.', 'interventionNames': ['Drug: Bendamustine', 'Drug: Polatuzumab vedotin (Liquid)', 'Drug: Rituximab']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in FL', 'description': 'Polatuzumab vedotin will be administered with bendamustine and rituximab in participants with FL.', 'interventionNames': ['Drug: Bendamustine', 'Drug: Polatuzumab vedotin (Liquid)', 'Drug: Rituximab']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in DLBCL', 'description': 'Polatuzumab vedotin will be administered with bendamustine and obinutuzumab in participants with DLBCL.', 'interventionNames': ['Drug: Bendamustine', 'Drug: Obinutuzumab', 'Drug: Polatuzumab vedotin (Liquid)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in FL', 'description': 'Polatuzumab vedotin will be administered with bendamustine and obinutuzumab in participants with FL.', 'interventionNames': ['Drug: Bendamustine', 'Drug: Obinutuzumab', 'Drug: Polatuzumab vedotin (Liquid)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm G (Phase II NF Cohort): Polatuzumab+BR in DLBCL', 'description': 'In this New Formulation (NF) cohort, Polatuzumab vedotin (lyophilized) will be administered with bendamustine and rituximab in participants with DLBCL.', 'interventionNames': ['Drug: Bendamustine', 'Drug: Rituximab', 'Drug: Polatuzumab vedotin (Lyophilized)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm H (Phase II NF Cohort): Polatuzumab+BR in DLBCL', 'description': 'In this NF cohort, Polatuzumab vedotin (lyophilized) will be administered with bendamustine and rituximab in participants with DLBCL.', 'interventionNames': ['Drug: Bendamustine', 'Drug: Rituximab', 'Drug: Polatuzumab vedotin (Lyophilized)']}], 'interventions': [{'name': 'Bendamustine', 'type': 'DRUG', 'otherNames': ['Treanda; Ribomustin; Levact'], 'description': 'Bendamustine 90 milligrams per meter-squared (mg/m\\^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).', 'armGroupLabels': ['Arm A (Phase II Randomization): Polatuzumab+BR in FL', 'Arm B (Phase II Randomization): BR in FL', 'Arm C (Phase II Randomization): Polatuzumab+BR in DLBCL', 'Arm D (Phase II Randomization): BR in DLBCL', 'Arm E (Phase II Expansion): Polatuzumab+BG in FL', 'Arm F (Phase II Expansion): Polatuzumab+BG in DLBCL', 'Arm G (Phase II NF Cohort): Polatuzumab+BR in DLBCL', 'Arm H (Phase II NF Cohort): Polatuzumab+BR in DLBCL', 'Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in DLBCL', 'Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in FL', 'Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in DLBCL', 'Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in FL']}, {'name': 'Obinutuzumab', 'type': 'DRUG', 'otherNames': ['GA101; Gazyva; Gazyvaro'], 'description': 'Obinutuzumab 1000 milligrams (mg) IV on Days 1, 8, and 15 of Cycle 1 and on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).', 'armGroupLabels': ['Arm E (Phase II Expansion): Polatuzumab+BG in FL', 'Arm F (Phase II Expansion): Polatuzumab+BG in DLBCL', 'Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in DLBCL', 'Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in FL']}, {'name': 'Polatuzumab vedotin (Liquid)', 'type': 'DRUG', 'otherNames': ['DCDS4501A'], 'description': 'Polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) administered IV on Day 2 of Cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).', 'armGroupLabels': ['Arm A (Phase II Randomization): Polatuzumab+BR in FL', 'Arm C (Phase II Randomization): Polatuzumab+BR in DLBCL', 'Arm E (Phase II Expansion): Polatuzumab+BG in FL', 'Arm F (Phase II Expansion): Polatuzumab+BG in DLBCL', 'Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in DLBCL', 'Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in FL', 'Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in DLBCL', 'Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in FL']}, {'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['Rituxan; MabThera'], 'description': 'Rituximab standard dose, 375 mg/m\\^2 IV on Day 1 of each cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).', 'armGroupLabels': ['Arm A (Phase II Randomization): Polatuzumab+BR in FL', 'Arm B (Phase II Randomization): BR in FL', 'Arm C (Phase II Randomization): Polatuzumab+BR in DLBCL', 'Arm D (Phase II Randomization): BR in DLBCL', 'Arm G (Phase II NF Cohort): Polatuzumab+BR in DLBCL', 'Arm H (Phase II NF Cohort): Polatuzumab+BR in DLBCL', 'Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in DLBCL', 'Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in FL']}, {'name': 'Polatuzumab vedotin (Lyophilized)', 'type': 'DRUG', 'otherNames': ['DCDS4501S'], 'description': 'Participants in the New Formulation (NF) Cohort (Arms G and H) will follow the same schedule and dosing requirements as participants in the other Phase II cohorts (Arms A-F).', 'armGroupLabels': ['Arm G (Phase II NF Cohort): Polatuzumab+BR in DLBCL', 'Arm H (Phase II NF Cohort): Polatuzumab+BR in DLBCL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-3300', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35805', 'city': 'Huntsville', 'state': 'Alabama', 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