Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-04-08 @ 1:51 PM
Study NCT ID:
NCT02055820
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2014-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax Combined With Chemotherapy in Participants With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C579720', 'term': 'venetoclax'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C543332', 'term': 'obinutuzumab'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to approximately 67 months', 'description': 'Safety population: All participants, who were enrolled in the study and received any amount of venetoclax or R-CHOP/G-CHOP were included in the safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Venetoclax 200 mg +R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Venetoclax 400 mg +R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Venetoclax 600 mg +R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Venetoclax 800 mg +R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 4, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Venetoclax 800 mg +R-CHOP Phase II', 'description': 'Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.', 'otherNumAtRisk': 208, 'deathsNumAtRisk': 208, 'otherNumAffected': 204, 'seriousNumAtRisk': 208, 'deathsNumAffected': 33, 'seriousNumAffected': 116}, {'id': 'EG005', 'title': 'Venetoclax 200 mg +G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG006', 'title': 'Venetoclax 400 mg +G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG007', 'title': 'Venetoclax 600 mg +G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG008', 'title': 'Venetoclax 800 mg + G-CHOP A', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. In this arm venetoclax was administered as follows: Cycle 1 Days 4-10; Cycles 2-8 Days 1-10, Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG009', 'title': 'Venetoclax 800 mg +G-CHOP B', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. In this arm venetoclax was administered as follows: Cycle 1 Days 4-8; Cycles 2-8 Days 1-5. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 117, 'numAffected': 73}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'FEBRILE NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'HAEMOLYTIC ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 47, 'numAffected': 23}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 18, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 10, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 409, 'numAffected': 134}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 17, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 13, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 16, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 10, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'PANCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 89, 'numAffected': 52}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 15, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'ANGINA PECTORIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'CARDIAC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'PALPITATIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'ICHTHYOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 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'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}], 'frequencyThreshold': '0.05'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety: Number of Participants With Dose-Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax 200 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG001', 'title': 'Venetoclax 400 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG002', 'title': 'Venetoclax 600 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG003', 'title': 'Venetoclax 800mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG004', 'title': 'Venetoclax 200mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG005', 'title': 'Venetoclax 400mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG006', 'title': 'Venetoclax 600mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG007', 'title': 'Venetoclax 800 mg + G-CHOP A', 'description': 'Venetoclax + G-CHOP 800 mg A Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. In this arm venetoclax was delivered in Cycle 1 on Days 4-10 and Cycles 2-8 on Days 1-10. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG008', 'title': 'Venetoclax 800 mg + G-CHOP B', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. In this arm ventoclax was delivered in Cycle 1 on Days 4-8 and Cycles 2-8 on Days 1-5. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Start of venetoclax administration (Cycle 1 Day 4 or 3 days after first CHOP dose) up to end of Cycle 2 (cycle length = 21 days)', 'description': 'DLTs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0). Decrease in B cells, lymphopenia, and leukopenia caused by lymphopenia were not considered DLTs but instead were expected outcomes of study treatment. Any Grade \\>/= 3 adverse event, that was attributed to having a reasonable possibility of being related to the combined administration of venetoclax plus R-CHOP or G-CHOP, that could not be attributed by the investigator to an alternative, clearly identifiable cause such as tumor progression, concurrent illness or medical condition, or concomitant medication and that occurred during the DLT observation period (start of venetoclax treatment through end of Cycle 2) was considered a DLT for dose-escalation purposes. Grade 3 or 4 neutropenia or thrombocytopenia identified on Day 1 of Cycle 2 or 3, resulting in dose delay were considered DLTs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All participants who enrolled in the study and received any amount of venetoclax or R-CHOP/G-CHOP were included in the safety population for safety analyses. Here, participants in the Dose Finding phase were analyzed.'}, {'type': 'PRIMARY', 'title': 'Percentage of Previously Untreated DLBCL Participants With Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Scan Using the Modified Lugano Classification Assessed by Independent Review Committee (IRC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax + R-CHOP 800 mg Phase II', 'description': 'Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.2', 'groupId': 'OG000', 'lowerLimit': '61.50', 'upperLimit': '74.47'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of treatment (up to approximately 6 months)', 'description': 'CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake \\</= mediastinum; 3) uptake \\< mediastinum but \\</= liver. No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With CR Defined by PET/CT Scan in Previously Untreated DLBCL Co-Expressing Both Bcl-2 and c-Myc Proteins (DE-DLBCL) Participants Assessed by IRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax + R-CHOP 800 mg Phase II', 'description': 'Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '55.32', 'upperLimit': '76.76'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of treatment (up to approximately 6 months)', 'description': 'CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake \\</= mediastinum; 3) uptake \\< mediastinum but \\</= liver. No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for subgroup of the ITT, DE Participants.'}, {'type': 'SECONDARY', 'title': 'Venetoclax Plasma PK: Area Under the Plasma Concentration-Time Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '124', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax 800mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG001', 'title': 'Venetoclax 200 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG002', 'title': 'Venetoclax 400 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG003', 'title': 'Venetoclax 600 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG004', 'title': 'Venetoclax + R-CHOP 800 mg', 'description': 'Phase I and II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG005', 'title': 'Venetoclax 200mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG006', 'title': 'Venetoclax 400mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG007', 'title': 'Venetoclax 600mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG008', 'title': 'Venetoclax + G-CHOP 800mg', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '.66', 'spread': 'NA', 'comment': 'N/A as there is only one participant in this cohort', 'groupId': 'OG000'}, {'value': '2.51', 'spread': '.97', 'groupId': 'OG001'}, {'value': '3.87', 'spread': '2.41', 'groupId': 'OG002'}, {'value': '3.70', 'spread': '1.59', 'groupId': 'OG003'}, {'value': '4.51', 'spread': '2.32', 'groupId': 'OG004'}, {'value': '2.55', 'spread': '1.13', 'groupId': 'OG005'}, {'value': '4.33', 'spread': '1.31', 'groupId': 'OG006'}, {'value': '5.13', 'spread': '2.41', 'groupId': 'OG007'}, {'value': '6.20', 'spread': '1.71', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose (within 30 minutes) & 2, 4, 6, 8 hours (Hr) postdose on Cycle 1 Day 4 (cycle length = 21 days)', 'description': 'AUC was calculated based on measurement of venetoclax concentration in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.\n\nData are reported as hour\\*micrograms per milliliter (hr\\*mcg/mL)', 'unitOfMeasure': 'hr*mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. Reporting according to study drug received. One participant mistakenly received only 100 mg instead of the planned 200 mg dose and was reported in a separate arm for PK outcome measures.'}, {'type': 'SECONDARY', 'title': 'Venetoclax Plasma PK: Time to Maximum Observed Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '124', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax + R-CHOP 100 mg', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG001', 'title': 'Venetoclax 200 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG002', 'title': 'Venetoclax 400 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG003', 'title': 'Venetoclax 600 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG004', 'title': 'Venetoclax 800mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG005', 'title': 'Venetoclax 200mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG006', 'title': 'Venetoclax 400mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG007', 'title': 'Venetoclax 600mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG008', 'title': 'Venetoclax + G-CHOP 800 mg', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': 'NA', 'comment': 'N/A as there is only one participant in this cohort', 'groupId': 'OG000'}, {'value': '4.59', 'spread': '1.08', 'groupId': 'OG001'}, {'value': '6.50', 'spread': '1.91', 'groupId': 'OG002'}, {'value': '5.52', 'spread': '2.07', 'groupId': 'OG003'}, {'value': '5.53', 'spread': '1.55', 'groupId': 'OG004'}, {'value': '5.72', 'spread': '1.42', 'groupId': 'OG005'}, {'value': '6.56', 'spread': '1.51', 'groupId': 'OG006'}, {'value': '5.30', 'spread': '2.38', 'groupId': 'OG007'}, {'value': '5.79', 'spread': '1.47', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)', 'description': 'Tmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.', 'unitOfMeasure': 'Hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. Reporting according to study drug received. One participant mistakenly received only 100 mg instead of the planned 200 mg dose and was reported in a separate arm for PK outcome measures.'}, {'type': 'SECONDARY', 'title': 'Venetoclax Plasma PK: Maximum Observed Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '124', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax + R-CHOP 100 mg', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG001', 'title': 'Venetoclax 200 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG002', 'title': 'Venetoclax 400 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG003', 'title': 'Venetoclax 600 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG004', 'title': 'Venetoclax 800mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG005', 'title': 'Venetoclax 200mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG006', 'title': 'Venetoclax 400mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG007', 'title': 'Venetoclax 600mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG008', 'title': 'Venetoclax + G-CHOP 800 mg', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '.09', 'spread': 'NA', 'comment': 'N/A as there is only one participant in this cohort', 'groupId': 'OG000'}, {'value': '.58', 'spread': '.32', 'groupId': 'OG001'}, {'value': '.92', 'spread': '.64', 'groupId': 'OG002'}, {'value': '.85', 'spread': '.33', 'groupId': 'OG003'}, {'value': '1.15', 'spread': '.48', 'groupId': 'OG004'}, {'value': '.52', 'spread': '.21', 'groupId': 'OG005'}, {'value': '1.26', 'spread': '.30', 'groupId': 'OG006'}, {'value': '1.00', 'spread': '.58', 'groupId': 'OG007'}, {'value': '1.54', 'spread': '.37', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)', 'description': 'Cmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.\n\nData are reported as micrograms per milliliter', 'unitOfMeasure': 'Ug/ML', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. Reporting according to study drug received. One participant mistakenly received only 100 mg instead of the planned 200 mg dose and was reported in a separate arm for PK outcome measures.'}, {'type': 'SECONDARY', 'title': 'Venetoclax Plasma PK: Minimum Plasma Concentration (Cmin) Within the Dosing Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '126', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax + R-CHOP 100 mg', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG001', 'title': 'Venetoclax 200 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG002', 'title': 'Venetoclax 400 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG003', 'title': 'Venetoclax 600 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG004', 'title': 'Venetoclax 800mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG005', 'title': 'Venetoclax 200mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG006', 'title': 'Venetoclax 400mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG007', 'title': 'Venetoclax 600mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG008', 'title': 'Venetoclax + G-CHOP 800 mg', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0714', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.522', 'spread': '0.441', 'groupId': 'OG001'}, {'value': '0.253', 'spread': '0.247', 'groupId': 'OG002'}, {'value': '0.387', 'spread': '0.141', 'groupId': 'OG003'}, {'value': '0.640', 'spread': '0.451', 'groupId': 'OG004'}, {'value': '0.134', 'spread': '0.107', 'groupId': 'OG005'}, {'value': '0.395', 'spread': '0.381', 'groupId': 'OG006'}, {'value': '0.612', 'spread': '0.535', 'groupId': 'OG007'}, {'value': '0.628', 'spread': '0.395', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)', 'description': 'Cmin was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. Reporting according to study drug received. One participant mistakenly received only 100 mg instead of the planned 200 mg dose and was reported in a separate arm for PK outcome measures.'}, {'type': 'SECONDARY', 'title': 'Prednisone Plasma PK: AUC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax PK Popluation', 'description': 'All participants in the study.\n\nPhase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '195', 'spread': '72.8', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '184', 'spread': '81.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)', 'description': 'AUC was determined based on measurement of Predisone concentrations in plasma over time.', 'unitOfMeasure': 'hr*mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: All participants who received study drug and provided at least one post-treatment PK sample. A similar dose strength of prednisone (100 mg) was administered across the treatment arms/venetoclax dose groups. Hence, the data are presented as an overall summary in Cycles 1 and 2.'}, {'type': 'SECONDARY', 'title': 'Prednisone Plasma PK: Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax PK Popluation', 'description': 'All participants in the study.\n\nPhase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.19', 'spread': '1.61', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.80', 'spread': '2.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)', 'description': 'Tmax was determined based on measurement of Predisone concentrations in plasma over time.', 'unitOfMeasure': 'Hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. A similar dose strength of prednisone (100 mg) was administered across the treatment arms/venetoclax dose groups. Hence, the data are presented as an overall summary in Cycles 1 and 2.'}, {'type': 'SECONDARY', 'title': 'Prednisone Plasma PK: Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax PK Popluation', 'description': 'All participants in the study.\n\nPhase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49.9', 'spread': '28.7', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43.2', 'spread': '17.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)', 'description': 'Cmax was determined based on measurement of Predisone concentrations in plasma over time.', 'unitOfMeasure': 'Ng/ML', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. A similar dose strength of prednisone (100 mg) was administered across the treatment arms/venetoclax dose groups. Hence, the data are presented as an overall summary in Cycles 1 and 2.'}, {'type': 'SECONDARY', 'title': 'Rituximab PK: Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax 800 mg', 'description': 'All participants in the study, who received 800 mg venetoclax.\n\nPhase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '173', 'spread': '39.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)', 'description': 'Cmax was determined using the post-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. The Cmax of rituximab is presented at the 800 mg Venetoclax dose group. Hence, the data is not presented by the treatment arms/Venetoclax dose groups.'}, {'type': 'SECONDARY', 'title': 'Rituximab PK: Cmin Within the Dosing Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax 800 mg', 'description': 'All participants in the study, who received 800 mg venetoclax.\n\nPhase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.1', 'spread': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose on Cycle 2 Day 1 (cycle length = 21 days)', 'description': 'Cmin was determined using the pre-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose on Day 1 of Cycle 2.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. The Cmin of rituximab is presented at the 800 mg Venetoclax dose group. Hence, the data is not presented by the treatment arms/Venetoclax dose groups.'}, {'type': 'SECONDARY', 'title': 'Obinutuzumab PK: Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax 800 mg', 'description': 'All participants in the study, who received 800 mg venetoclax.\n\nPhase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '326', 'spread': '76', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)', 'description': 'Cmax was determined using the post-dose obinutuzumab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. The Cmax of obinutuzumab is presented at the 800 mg Venetoclax dose group. Hence, the data is not presented by the treatment arms/Venetoclax dose groups.'}, {'type': 'SECONDARY', 'title': 'Cyclophosphamide PK: Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax PK Popluation', 'description': 'All participants in the study.\n\nPhase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.1', 'spread': '7.51', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)', 'description': 'Cmax was determined using the post-dose Cyclophosphamide plasma concentrations on Cycle 1 Day 1.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. Given a single dose strength of Cyclophosphamide was administered across the different Venetoclax dose groups and treatment arms, hence the data are presented as an overall summary.'}, {'type': 'SECONDARY', 'title': 'Doxorubicin PK: Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax PK Popluation', 'description': 'All participants in the study.\n\nPhase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '1260', 'spread': '911', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)', 'description': 'Cmax was determined using the post-dose Doxorubicin plasma concentrations.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. Given a single dose strength of Doxorubicin was administered across the different Venetoclax dose groups and treatment arms, hence the data are presented as an overall summary.'}, {'type': 'SECONDARY', 'title': 'Vincristine PK: Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax PK Popluation', 'description': 'All participants in the study.\n\nPhase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.0', 'spread': '44.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)', 'description': 'Cmax was determined using the post-dose Vincristine plasma concentrations.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. Given a single dose strength of Vincristine was administered across the different Venetoclax dose groups and treatment arms, hence the data are presented as an overall summary.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response Defined as Partial Response (PR) or Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Using the Modified Lugano Classification Assessed by IRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax + R-CHOP 800 mg Phase II', 'description': 'Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.5', 'groupId': 'OG000', 'lowerLimit': '75.61', 'upperLimit': '86.51'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to end of treatment (up to approximately 6 months)', 'description': 'Objective Response defined as PR (partial response) or CR (complete response) at end of treatment.\n\nCR: Lymph nodes and extra-lymphatic sites with score 1, 2 or 3 on a 5-point scale (with a higher score being a worse outcome). No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.\n\nPR: Lymph nodes and extralymphatic sites with score of 4 or 5 on the 5-point scale with reduced uptake compared with baseline and residual mass(es) of any size. CT-based response criteria for PR must also be met. No new lesions. In bone marrow residual uptake could be higher than in normal marrow but must be reduced compared with baseline; persistent focal changes in the marrow to be considered for further evaluation with magnetic resonance imaging (MRI) or biopsy or an interval scan. OR=PR+CR', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Are Alive and Without Disease Progression at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '211', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax 200 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG001', 'title': 'Venetoclax 400 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG002', 'title': 'Venetoclax 600 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG003', 'title': 'Venetoclax 800mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG004', 'title': 'Venetoclax + R-CHOP 800 mg Phase II', 'description': 'Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG005', 'title': 'Venetoclax 200mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG006', 'title': 'Venetoclax 400mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG007', 'title': 'Venetoclax 600mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG008', 'title': 'Venetoclax 800 mg + G-CHOP A', 'description': 'Venetoclax + G-CHOP 800 mg A Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. In this arm venetoclax was delivered in Cycle 1 on Days 4-10 and Cycles 2-8 on Days 1-10. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG009', 'title': 'Venetoclax 800 mg + G-CHOP B', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. In this arm ventoclax was delivered in Cycle 1 on Days 4-8 and Cycles 2-8 on Days 1-5. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.71', 'groupId': 'OG000', 'lowerLimit': '59.79', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '100.00', 'upperLimit': '100.00'}, {'value': '87.50', 'groupId': 'OG002', 'lowerLimit': '64.58', 'upperLimit': '100.00'}, {'value': '66.67', 'groupId': 'OG003', 'lowerLimit': '28.95', 'upperLimit': '100.00'}, {'value': '88.99', 'groupId': 'OG004', 'lowerLimit': '82.65', 'upperLimit': '92.10'}, {'value': '100.00', 'groupId': 'OG005', 'lowerLimit': '100.00', 'upperLimit': '100.00'}, {'value': '75.00', 'groupId': 'OG006', 'lowerLimit': '32.57', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG007', 'lowerLimit': '100.00', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG008', 'lowerLimit': '100.00', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG009', 'lowerLimit': '100.00', 'upperLimit': '100.00'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Progressive disease (PD) was determined using the modified Lugano classification criteria. For PET-CT-based PD: Score 4 (uptake moderately \\> liver) or 5 (uptake markedly higher than liver and/or new lesions) with an increase in intensity of uptake from baseline in target nodes and nodal lesions, new FDG-uptake foci of extranodal lesions consistent with lymphoma at interim or end-of-treatment assessment, no non-measured lesions, new FDG-uptake foci consistent with lymphoma, new or recurrent FDG-uptake foci in bone marrow. For CT-based PD: \\>/= 50% decrease in SPD of up to 6 target measureable nodes and extranodal sites; non-measured lesion should be absent/normal, have regressed, but not increased; no new lesions.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With CR Defined by Computed Tomography (CT) Scan Using the Modified Lugano Classification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax + R-CHOP 800 mg Phase II', 'description': 'Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.4', 'groupId': 'OG000', 'lowerLimit': '30.89', 'upperLimit': '44.35'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of treatment (approx. 6 months)', 'description': 'CR was defined as follows according to modified Lugano classification for CT-based response: Target nodes/nodal masses must have regressed to \\</= 1.5 cm in longest transverse diameter of a lesion (LDi), no extra-lymphatic sites of disease, absence of non-measured lesions, organ enlargement must have regressed to normal, no new lesions, and if the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Safety: Percentage of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '208', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax 200 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG001', 'title': 'Venetoclax 400 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG002', 'title': 'Venetoclax 600 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG003', 'title': 'Venetoclax 800mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG004', 'title': 'Venetoclax + R-CHOP 800 mg Phase II', 'description': 'Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG005', 'title': 'Venetoclax 200mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG006', 'title': 'Venetoclax 400mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG007', 'title': 'Venetoclax 600mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG008', 'title': 'Venetoclax 800 mg + G-CHOP A', 'description': 'Venetoclax + G-CHOP 800 mg A Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. In this arm venetoclax was delivered in Cycle 1 on Days 4-10 and Cycles 2-8 on Days 1-10. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG009', 'title': 'Venetoclax 800 mg + G-CHOP B', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. In this arm ventoclax was delivered in Cycle 1 on Days 4-8 and Cycles 2-8 on Days 1-5. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000'}, {'value': '100.00', 'groupId': 'OG001'}, {'value': '100.00', 'groupId': 'OG002'}, {'value': '100.00', 'groupId': 'OG003'}, {'value': '99.0', 'groupId': 'OG004'}, {'value': '100.00', 'groupId': 'OG005'}, {'value': '100.00', 'groupId': 'OG006'}, {'value': '100.00', 'groupId': 'OG007'}, {'value': '100.00', 'groupId': 'OG008'}, {'value': '100.00', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to approximately 36 months', 'description': 'An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All patients who enrolled in the study and received any amount of venetoclax or R-CHOP/G-CHOP were included in the safety population for safety analyses'}, {'type': 'SECONDARY', 'title': 'Safety: Percentage of Participants Maintaining Relative Dose Intensity of CHOP Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax + R-CHOP Arm', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days.\n\nPhase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days.\n\nParticipants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG001', 'title': 'Venetoclax 600mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}], 'classes': [{'title': 'Cyclophosphamide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000'}, {'value': '77.4', 'groupId': 'OG001'}]}]}, {'title': 'Doxorubicin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000'}, {'value': '77.4', 'groupId': 'OG001'}]}]}, {'title': 'Vincristine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.6', 'groupId': 'OG000'}, {'value': '78.1', 'groupId': 'OG001'}]}]}, {'title': 'Prednisone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.4', 'groupId': 'OG000'}, {'value': '81.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Cycle 6 (cycle length = 21 days)', 'description': 'Maintenance of relative dose intensity was defined as a dose intensity of \\>/= 90%.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All patients who enrolled in the study and received any amount of venetoclax or R-CHOP/G-CHOP were included in the safety population for safety analyses. Overall R-CHOP and G-CHOP arms were analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Relative Dose Intensity of Venetoclax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '208', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Venetoclax 200 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG001', 'title': 'Venetoclax 400 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG002', 'title': 'Venetoclax 600 mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG003', 'title': 'Venetoclax 800mg + R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG004', 'title': 'Venetoclax + R-CHOP 800 mg Phase II', 'description': 'Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG005', 'title': 'Venetoclax 200mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG006', 'title': 'Venetoclax 400mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG007', 'title': 'Venetoclax 600mg + G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG008', 'title': 'Venetoclax + G-CHOP 800 mg', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'OG009', 'title': 'Venetoclax + G-CHOP 800mg B', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days.'}], 'classes': [{'title': '<80%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '204', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}, {'value': '0.00', 'groupId': 'OG003'}, {'value': '26.0', 'groupId': 'OG004'}, {'value': '100.00', 'groupId': 'OG005'}, {'value': '14.3', 'groupId': 'OG006'}, {'value': '50.0', 'groupId': 'OG007'}, {'value': '83.3', 'groupId': 'OG008'}, {'value': '100.0', 'groupId': 'OG009'}]}]}, {'title': '80-<85%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '204', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}, {'value': '0.00', 'groupId': 'OG003'}, {'value': '3.4', 'groupId': 'OG004'}, {'value': '0.00', 'groupId': 'OG005'}, {'value': '14.3', 'groupId': 'OG006'}, {'value': '16.7', 'groupId': 'OG007'}, {'value': '0.00', 'groupId': 'OG008'}, {'value': '0.00', 'groupId': 'OG009'}]}]}, {'title': '85-<90%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '204', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}, {'value': '0.00', 'groupId': 'OG003'}, {'value': '2.9', 'groupId': 'OG004'}, {'value': '0.00', 'groupId': 'OG005'}, {'value': '0.00', 'groupId': 'OG006'}, {'value': '0.00', 'groupId': 'OG007'}, {'value': '16.7', 'groupId': 'OG008'}, {'value': '0.00', 'groupId': 'OG009'}]}]}, {'title': '>=90%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '204', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '100.00', 'groupId': 'OG001'}, {'value': '62.5', 'groupId': 'OG002'}, {'value': '100.00', 'groupId': 'OG003'}, {'value': '67.6', 'groupId': 'OG004'}, {'value': '0.00', 'groupId': 'OG005'}, {'value': '71.4', 'groupId': 'OG006'}, {'value': '33.3', 'groupId': 'OG007'}, {'value': '0.00', 'groupId': 'OG008'}, {'value': '0.00', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Cycle 6 (cycle length = 21 days)', 'description': 'Dose intensity was categorized as \\< 80%, 80% to \\< 85%, 85% to \\< 90%, or \\>/= 90%.', 'unitOfMeasure': 'Percentage of Partcipants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All patients who enrolled in the study and received any amount of venetoclax or R-CHOP/G-CHOP were included in the safety population for safety analyses'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Venetoclax 200 mg +R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'FG001', 'title': 'Venetoclax 400 mg +R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'FG002', 'title': 'Venetoclax 600 mg +R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'FG003', 'title': 'Venetoclax 800 mg +R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'FG004', 'title': 'Venetoclax 800 mg +R-CHOP Phase II', 'description': 'Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'FG005', 'title': 'Venetoclax 200 mg +G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'FG006', 'title': 'Venetoclax 400 mg +G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'FG007', 'title': 'Venetoclax 600 mg +G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'FG008', 'title': 'Venetoclax 800 mg + G-CHOP A', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. In this arm venetoclax was administered as follows: Cycle 1 Days 4-10; Cycles 2-8 Days 1-10, Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'FG009', 'title': 'Venetoclax 800 mg +G-CHOP B', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. In this arm venetoclax was administered as follows: Cycle 1 Days 4-8; Cycles 2-8 Days 1-5. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}], 'periods': [{'title': 'Phase I: Dose-Finding', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}, {'title': 'Phase II: Expansion', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '208'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '159'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '49'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '33'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'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': '4'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'At start the trial had a randomised-controlled component, until July 2016 once the arm B (Gazyva) got closed following the publication of results of another trial. Since July 2016, the trial was single-arm, not randomised anymore, and kept including patients in only 1 arm (Arm A, rituximab).', 'preAssignmentDetails': 'The data reported for participant flow is based on safety population, which includes all participants who received at least one dose of study medication.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '208', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '264', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'Venetoclax 200 mg +R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'BG001', 'title': 'Venetoclax 400 mg +R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'BG002', 'title': 'Venetoclax 600 mg +R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'BG003', 'title': 'Venetoclax 800 mg +R-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'BG004', 'title': 'Venetoclax 800 mg +R-CHOP Phase II', 'description': 'Phase II: Participants received 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'BG005', 'title': 'Venetoclax 200 mg +G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'BG006', 'title': 'Venetoclax 400 mg +G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'BG007', 'title': 'Venetoclax 600 mg +G-CHOP', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'BG008', 'title': 'Venetoclax 800 mg + G-CHOP A', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. In this arm venetoclax was administered as follows: Cycle 1 Days 4-10; Cycles 2-8 Days 1-10, Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'BG009', 'title': 'Venetoclax 800 mg +G-CHOP B', 'description': 'Phase I: Participants received 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle consisted of 21 days. In this arm venetoclax was administered as follows: Cycle 1 Days 4-8; Cycles 2-8 Days 1-5. Participants who experienced ongoing response without excessive toxicity could receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.0', 'spread': '9.2', 'groupId': 'BG000'}, {'value': '61.0', 'spread': '13.1', 'groupId': 'BG001'}, {'value': '57.0', 'spread': '9.5', 'groupId': 'BG002'}, {'value': '56.3', 'spread': '11.9', 'groupId': 'BG003'}, {'value': '61.4', 'spread': '12.8', 'groupId': 'BG004'}, {'value': '52.1', 'spread': '16.2', 'groupId': 'BG005'}, {'value': '60.9', 'spread': '6.3', 'groupId': 'BG006'}, {'value': '66.7', 'spread': '4.2', 'groupId': 'BG007'}, {'value': '60.5', 'spread': '13.7', 'groupId': 'BG008'}, {'value': '66.8', 'spread': '6.7', 'groupId': 'BG009'}, {'value': '61.2', 'spread': '12.5', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '94', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '120', 'groupId': 'BG010'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '114', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '144', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '151', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '187', 'groupId': 'BG010'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '73', 'groupId': 'BG010'}]}]}], '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': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}]}, {'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': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '154', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '187', 'groupId': 'BG010'}]}, {'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'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '64', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-10', 'size': 2026114, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-01-22T11:37', 'hasProtocol': True}, {'date': '2017-01-24', 'size': 11173809, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-01-22T11:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 267}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-26', 'studyFirstSubmitDate': '2014-02-04', 'resultsFirstSubmitDate': '2018-06-26', 'studyFirstSubmitQcDate': '2014-02-04', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-19', 'studyFirstPostDateStruct': {'date': '2014-02-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: Number of Participants With Dose-Limiting Toxicities (DLTs)', 'timeFrame': 'Start of venetoclax administration (Cycle 1 Day 4 or 3 days after first CHOP dose) up to end of Cycle 2 (cycle length = 21 days)', 'description': 'DLTs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0). Decrease in B cells, lymphopenia, and leukopenia caused by lymphopenia were not considered DLTs but instead were expected outcomes of study treatment. Any Grade \\>/= 3 adverse event, that was attributed to having a reasonable possibility of being related to the combined administration of venetoclax plus R-CHOP or G-CHOP, that could not be attributed by the investigator to an alternative, clearly identifiable cause such as tumor progression, concurrent illness or medical condition, or concomitant medication and that occurred during the DLT observation period (start of venetoclax treatment through end of Cycle 2) was considered a DLT for dose-escalation purposes. Grade 3 or 4 neutropenia or thrombocytopenia identified on Day 1 of Cycle 2 or 3, resulting in dose delay were considered DLTs.'}, {'measure': 'Percentage of Previously Untreated DLBCL Participants With Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Scan Using the Modified Lugano Classification Assessed by Independent Review Committee (IRC)', 'timeFrame': 'Baseline up to end of treatment (up to approximately 6 months)', 'description': 'CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake \\</= mediastinum; 3) uptake \\< mediastinum but \\</= liver. No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy'}, {'measure': 'Percentage of Participants With CR Defined by PET/CT Scan in Previously Untreated DLBCL Co-Expressing Both Bcl-2 and c-Myc Proteins (DE-DLBCL) Participants Assessed by IRC', 'timeFrame': 'Baseline up to end of treatment (up to approximately 6 months)', 'description': 'CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake \\</= mediastinum; 3) uptake \\< mediastinum but \\</= liver. No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.'}], 'secondaryOutcomes': [{'measure': 'Venetoclax Plasma PK: Area Under the Plasma Concentration-Time Curve (AUC)', 'timeFrame': 'Predose (within 30 minutes) & 2, 4, 6, 8 hours (Hr) postdose on Cycle 1 Day 4 (cycle length = 21 days)', 'description': 'AUC was calculated based on measurement of venetoclax concentration in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.\n\nData are reported as hour\\*micrograms per milliliter (hr\\*mcg/mL)'}, {'measure': 'Venetoclax Plasma PK: Time to Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': 'Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)', 'description': 'Tmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.'}, {'measure': 'Venetoclax Plasma PK: Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)', 'description': 'Cmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.\n\nData are reported as micrograms per milliliter'}, {'measure': 'Venetoclax Plasma PK: Minimum Plasma Concentration (Cmin) Within the Dosing Interval', 'timeFrame': 'Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)', 'description': 'Cmin was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.'}, {'measure': 'Prednisone Plasma PK: AUC', 'timeFrame': 'Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)', 'description': 'AUC was determined based on measurement of Predisone concentrations in plasma over time.'}, {'measure': 'Prednisone Plasma PK: Tmax', 'timeFrame': 'Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)', 'description': 'Tmax was determined based on measurement of Predisone concentrations in plasma over time.'}, {'measure': 'Prednisone Plasma PK: Cmax', 'timeFrame': 'Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)', 'description': 'Cmax was determined based on measurement of Predisone concentrations in plasma over time.'}, {'measure': 'Rituximab PK: Cmax', 'timeFrame': 'End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)', 'description': 'Cmax was determined using the post-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1.'}, {'measure': 'Rituximab PK: Cmin Within the Dosing Interval', 'timeFrame': 'Pre-dose on Cycle 2 Day 1 (cycle length = 21 days)', 'description': 'Cmin was determined using the pre-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose on Day 1 of Cycle 2.'}, {'measure': 'Obinutuzumab PK: Cmax', 'timeFrame': 'End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)', 'description': 'Cmax was determined using the post-dose obinutuzumab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1.'}, {'measure': 'Cyclophosphamide PK: Cmax', 'timeFrame': 'End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)', 'description': 'Cmax was determined using the post-dose Cyclophosphamide plasma concentrations on Cycle 1 Day 1.'}, {'measure': 'Doxorubicin PK: Cmax', 'timeFrame': 'End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)', 'description': 'Cmax was determined using the post-dose Doxorubicin plasma concentrations.'}, {'measure': 'Vincristine PK: Cmax', 'timeFrame': 'End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)', 'description': 'Cmax was determined using the post-dose Vincristine plasma concentrations.'}, {'measure': 'Percentage of Participants With Objective Response Defined as Partial Response (PR) or Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Using the Modified Lugano Classification Assessed by IRC', 'timeFrame': 'Baseline to end of treatment (up to approximately 6 months)', 'description': 'Objective Response defined as PR (partial response) or CR (complete response) at end of treatment.\n\nCR: Lymph nodes and extra-lymphatic sites with score 1, 2 or 3 on a 5-point scale (with a higher score being a worse outcome). No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.\n\nPR: Lymph nodes and extralymphatic sites with score of 4 or 5 on the 5-point scale with reduced uptake compared with baseline and residual mass(es) of any size. CT-based response criteria for PR must also be met. No new lesions. In bone marrow residual uptake could be higher than in normal marrow but must be reduced compared with baseline; persistent focal changes in the marrow to be considered for further evaluation with magnetic resonance imaging (MRI) or biopsy or an interval scan. OR=PR+CR'}, {'measure': 'Percentage of Participants Who Are Alive and Without Disease Progression at Month 12', 'timeFrame': 'Month 12', 'description': 'Progressive disease (PD) was determined using the modified Lugano classification criteria. For PET-CT-based PD: Score 4 (uptake moderately \\> liver) or 5 (uptake markedly higher than liver and/or new lesions) with an increase in intensity of uptake from baseline in target nodes and nodal lesions, new FDG-uptake foci of extranodal lesions consistent with lymphoma at interim or end-of-treatment assessment, no non-measured lesions, new FDG-uptake foci consistent with lymphoma, new or recurrent FDG-uptake foci in bone marrow. For CT-based PD: \\>/= 50% decrease in SPD of up to 6 target measureable nodes and extranodal sites; non-measured lesion should be absent/normal, have regressed, but not increased; no new lesions.'}, {'measure': 'Percentage of Participants With CR Defined by Computed Tomography (CT) Scan Using the Modified Lugano Classification', 'timeFrame': 'Baseline up to end of treatment (approx. 6 months)', 'description': 'CR was defined as follows according to modified Lugano classification for CT-based response: Target nodes/nodal masses must have regressed to \\</= 1.5 cm in longest transverse diameter of a lesion (LDi), no extra-lymphatic sites of disease, absence of non-measured lesions, organ enlargement must have regressed to normal, no new lesions, and if the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.'}, {'measure': 'Safety: Percentage of Participants With Adverse Events', 'timeFrame': 'Baseline up to approximately 36 months', 'description': 'An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.'}, {'measure': 'Safety: Percentage of Participants Maintaining Relative Dose Intensity of CHOP Chemotherapy', 'timeFrame': 'Baseline up to Cycle 6 (cycle length = 21 days)', 'description': 'Maintenance of relative dose intensity was defined as a dose intensity of \\>/= 90%.'}, {'measure': 'Relative Dose Intensity of Venetoclax', 'timeFrame': 'Baseline up to Cycle 6 (cycle length = 21 days)', 'description': 'Dose intensity was categorized as \\< 80%, 80% to \\< 85%, 85% to \\< 90%, or \\>/= 90%.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphoma, Non-Hodgkin']}, 'referencesModule': {'references': [{'pmid': '30850381', 'type': 'RESULT', 'citation': 'Zelenetz AD, Salles G, Mason KD, Casulo C, Le Gouill S, Sehn LH, Tilly H, Cartron G, Chamuleau MED, Goy A, Tam CS, Lugtenburg PJ, Petrich AM, Sinha A, Samineni D, Herter S, Ingalla E, Szafer-Glusman E, Klein C, Sampath D, Kornacker M, Mobasher M, Morschhauser F. Venetoclax plus R- or G-CHOP in non-Hodgkin lymphoma: results from the CAVALLI phase 1b trial. Blood. 2019 May 2;133(18):1964-1976. doi: 10.1182/blood-2018-11-880526. Epub 2019 Mar 8.'}, {'pmid': '34822104', 'type': 'DERIVED', 'citation': 'Samineni D, Huang W, Gibiansky L, Ding H, Zhang R, Li C, Sinha A, Rajwanshi R, Humphrey K, Bazeos A, Salem AH, Miles D. Population Pharmacokinetics and Exposure-Response Analyses for Venetoclax in Combination with R-CHOP in Relapsed/Refractory and Previously Untreated Patients with Diffuse Large B Cell Lymphoma. Adv Ther. 2022 Jan;39(1):598-618. doi: 10.1007/s12325-021-01919-z. Epub 2021 Nov 25.'}, {'pmid': '33538797', 'type': 'DERIVED', 'citation': 'Morschhauser F, Feugier P, Flinn IW, Gasiorowski R, Greil R, Illes A, Johnson NA, Larouche JF, Lugtenburg PJ, Patti C, Salles GA, Trneny M, de Vos S, Mir F, Samineni D, Kim SY, Jiang Y, Punnoose E, Sinha A, Clark E, Spielewoy N, Humphrey K, Bazeos A, Zelenetz AD. A phase 2 study of venetoclax plus R-CHOP as first-line treatment for patients with diffuse large B-cell lymphoma. Blood. 2021 Feb 4;137(5):600-609. doi: 10.1182/blood.2020006578.'}]}, 'descriptionModule': {'briefSummary': "This is a multicenter, open-label, dose-finding study of venetoclax administered orally in combination with rituximab (R) or obinutuzumab (G) and standard doses of cyclophosphamide, doxorubicin, vincristine and oral prednisone (CHOP) in participants with Non-Hodgkin's Lymphoma (NHL). The study consisted of 2 stages: a dose-finding Phase Ib stage and a Phase II expansion stage. In the Phase I portion of the study, participants were randomized to one of 2 treatment arms venetoclax in combination with R-CHOP (Arm A) and venetoclax in combination with G-CHOP (Arm B) and explored the doses of venetoclax in combination with R-CHOP and G-CHOP. The maximum tolerated dose (MTD) of venetoclax in combination with R-CHOP and G-CHOP was determined during the dose-finding stage. For the Phase II portion of the study, the venetoclax dose for venetoclax + R-CHOP was on a non-continuous dosing schedule as determined by the Phase Ib portion of the study based on safety and tolerability observed in participants treated in the dose escalation portion of the study. On 17 July 2016, Roche/Genentech as the sponsor of Study BO21005 (Goya study), a Phase III study that evaluated G CHOP versus R-CHOP in 1L DLBCL, informed through a press release that the primary endpoint of investigator-assessed PFS was not met. Given these results, Arm B (venetoclax + G-CHOP) was not expanded in Phase II in patients who are first-line with DLBCL."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGeneral Inclusion Criteria:\n\n* At least one bi-dimensionally measurable lymphoma lesion on CT scan defined as \\> 1.5 cm in its longest dimension, which is also FDG avid by screening PET scan.\n* Confirmed availability of archival or freshly biopsied tumor tissue prior to study enrollment\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n* Adequate hematologic function\n* For female participants of childbearing potential, agreement to use highly effective forms of contraception\n\nDose-Escalation Portion of the Study:\n\n* Participants must have histologically confirmed B-cell NHL, except MCL or SLL\n* Participants must have never received previous R-CHOP treatment\n* Any relapsed/refractory participants that are enrolled during the dose escalation should have received only a single previous treatment regimen\n\nExpansion Portion of the Study:\n\n* Participants must have previously untreated CD20-positive DLBCL and IPI score must be 2-5\n\nExclusion Criteria:\n\nGeneral Exclusion Criteria:\n\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products\n* Contraindication to receive any of the individual components of CHOP, rituximab or obinutuzumab\n* Prior anthracycline therapy\n* Participants with ongoing corticosteroid use \\>30 mg per day of prednisone or equivalent\n* CNS lymphoma or primary mediastinal DLBCL\n* Vaccination with live vaccines within 28 days prior to randomization\n* Chemotherapy or other investigational therapy within 28 days prior to the start of Cycle 1\n* History of other malignancy that could affect compliance with the protocol or interpretation of results\n* Evidence of significant, uncontrolled concomitant disease\n* Significant cardiovascular disease or significant pulmonary disease\n* Left ventricular ejection fraction less than (\\<) 50% as defined by multiple-gated acquisition (MUGA)\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 (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1 Day 1\n* Received the following agents within 7 days prior to the first dose of venetoclax: steroid therapy for anti-neoplastic intent; strong and moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers; grapefruit/grapefruit products, seville oranges or star fruit within 3 days prior to the first dose of venetoclax\n* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis\n* Recent major surgery\n* Women who are pregnant or lactating\n\nDose-Escalation Portion of the Study:\n\n* Participants with confirmed mantle cell lymphoma (MCL) or small lymphocytic lymphoma (SLL)\n\nExpansion Portion of the Study:\n\n* Participants with transformed lymphoma (participants with discordant bone marrow involvement (i.e., low grade histology in bone marrow) may be considered after discussion with the Medical Monitor)\n* Prior therapy for NHL'}, 'identificationModule': {'nctId': 'NCT02055820', 'briefTitle': "A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax Combined With Chemotherapy in Participants With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL", 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': "A Phase Ib/II, Open-Label Study Evaluating the Safety, Efficacy and Pharmacokinetics of GDC-0199 (ABT-199) in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL", 'orgStudyIdInfo': {'id': 'GO27878'}, 'secondaryIdInfos': [{'id': '2013-003749-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Venetoclax + G-CHOP Arm', 'description': 'Phase I: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle will consist of 21 days. Phase II: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle will consist of 21 days. For both phase I and II, participants with ongoing response without excessive toxicity may receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.', 'interventionNames': ['Drug: Venetoclax', 'Drug: Cyclophosphamide', 'Drug: Obinutuzumab', 'Drug: Doxorubicin', 'Drug: Vincristine', 'Drug: Prednisone']}, {'type': 'EXPERIMENTAL', 'label': 'Venetoclax + R-CHOP Arm', 'description': 'Phase I: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle will consist of 21 days. Phase II: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle will consist of 21 days. For both phase I and II, participants with ongoing response without excessive toxicity may receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.', 'interventionNames': ['Drug: Venetoclax', 'Drug: Cyclophosphamide', 'Drug: Rituximab', 'Drug: Doxorubicin', 'Drug: Vincristine', 'Drug: Prednisone']}], 'interventions': [{'name': 'Venetoclax', 'type': 'DRUG', 'otherNames': ['GDC-0199, ABT-199'], 'description': 'Venetoclax 200 to 800 milligrams (mg) tablets will be administered orally once daily (QD) on Days 4-10 of Cycle 1 and Days 1-10 of Cycles 2-8 during Phase I and MTD will be administered according to the same schedule during Phase II.', 'armGroupLabels': ['Venetoclax + G-CHOP Arm', 'Venetoclax + R-CHOP Arm']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Cyclophosphamide 750 milligrams per square meter (mg/m\\^2) administered intravenously (IV) on Day 1 of each 21-day cycle up to Cycle 6.', 'armGroupLabels': ['Venetoclax + G-CHOP Arm', 'Venetoclax + R-CHOP Arm']}, {'name': 'Obinutuzumab', 'type': 'DRUG', 'description': 'Obinutuzumab will be administered by IV infusion as an absolute dose of 1000 mg on Days 1, 8, 15 of Cycle 1 and Day 1 of Cycles 2-8 (cycle length = 21 days).', 'armGroupLabels': ['Venetoclax + G-CHOP Arm']}, {'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['MabThera/Rituxan'], 'description': 'Rituximab 375 mg/m\\^2 dose will be administered IV on Day 1 of every 21-day cycle.', 'armGroupLabels': ['Venetoclax + R-CHOP Arm']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'description': 'Doxorubicin 50 mg/m\\^2 administered IV on Day 1 of each 21-day cycle up to Cycle 6.', 'armGroupLabels': ['Venetoclax + G-CHOP Arm', 'Venetoclax + R-CHOP Arm']}, {'name': 'Vincristine', 'type': 'DRUG', 'description': 'Vincristine 1.4 mg/m\\^2 (maximum 2 mg) administered IV on Day 1 of each 21-day cycle up to Cycle 6.', 'armGroupLabels': ['Venetoclax + G-CHOP Arm', 'Venetoclax + R-CHOP Arm']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': 'Prednisone 100 mg per day orally on Days 1-5 of each 21-day cycle up to Cycle 6.', 'armGroupLabels': ['Venetoclax + G-CHOP Arm', 'Venetoclax + R-CHOP Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'St. Jude Heritage Healthcare', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Jonsson Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93454', 'city': 'Santa Maria', 'state': 'California', 'country': 'United States', 'facility': 'Central Coast Medical Oncology', 'geoPoint': {'lat': 34.95303, 'lon': -120.43572}}, {'zip': '63129', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'The West Clinici', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center; 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