Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT03520920
Status:
COMPLETED
Last Update Posted:
2024-10-26
First Post:
2018-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
BTK Inhibitor BGB-3111 in Chinese Participants With Diffuse Large B-Cell Lymphoma (Non-GCB) and Indolent Lymphoma (FL and MZL)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'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': 'C000629551', 'term': 'zanubrutinib'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@beigene.com', 'phone': '+1-877-828-5568', 'title': 'Study Director', 'organization': 'BeiGene'}, 'certainAgreement': {'otherDetails': 'BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \\& may request a further delay to protect its IP rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 through approximately 2.5 years', 'description': 'Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma', 'description': 'Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 19, 'seriousNumAtRisk': 20, 'deathsNumAffected': 13, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Relapsed/Refractory Follicular Lymphoma', 'description': 'Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 16, 'seriousNumAtRisk': 16, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Relapsed/Refractory Marginal Zone Lymphoma', 'description': 'Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Haemoglobinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}], 'seriousEvents': [{'term': 'Lymph gland infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Lymphangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pulmonary mycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hypoproteinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Response Rate (ORR) As Measured By The Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma', 'description': 'Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\\^2 intravenously on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}, {'id': 'OG001', 'title': 'Relapsed/Refractory Follicular Lymphoma', 'description': 'Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\\^2 intravenously on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}, {'id': 'OG002', 'title': 'Relapsed/Refractory Marginal Zone Lymphoma', 'description': 'Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\\^2 intravenously on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '15.4', 'upperLimit': '59.2'}, {'value': '56.3', 'groupId': 'OG001', 'lowerLimit': '29.9', 'upperLimit': '80.2'}, {'value': '60.0', 'groupId': 'OG002', 'lowerLimit': '14.7', 'upperLimit': '94.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 2.5 years', 'description': 'The percentage of participants whose best overall response met partial response (PR) or complete response (CR) criteria among all participants. The 95% confidence interval (CI) was calculated with the Clopper-Pearson method.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab) on the study.'}, {'type': 'SECONDARY', 'title': 'Duration Of Response (DOR) As Determined By Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma', 'description': 'Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}, {'id': 'OG001', 'title': 'Relapsed/Refractory Follicular Lymphoma', 'description': 'Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}, {'id': 'OG002', 'title': 'Relapsed/Refractory Marginal Zone Lymphoma', 'description': 'Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.79', 'comment': 'NA = Not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '0.72', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Not estimable due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '5.45', 'upperLimit': 'NA'}, {'value': '22.18', 'comment': 'NA = Not estimable due to insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': '8.31', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 2.5 years', 'description': 'The DOR was defined as the time from the date that the response criteria were first met to the date that progressive disease (PD) was objectively documented or death, whichever occurred first. Medians were estimated by the Kaplan-Meier method with 95% CIs estimated using the Brookmeyer and Crowley method.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab) on the study. Duration of response was summarized for responders (participants with a best response of partial response or higher) only.'}, {'type': 'SECONDARY', 'title': 'DOR: Event-free Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma', 'description': 'Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}, {'id': 'OG001', 'title': 'Relapsed/Refractory Follicular Lymphoma', 'description': 'Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}, {'id': 'OG002', 'title': 'Relapsed/Refractory Marginal Zone Lymphoma', 'description': 'Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}], 'classes': [{'title': '6 months', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '80.4'}, {'value': '88.9', 'groupId': 'OG001', 'lowerLimit': '43.3', 'upperLimit': '98.4'}, {'value': '100.0', 'comment': 'NA = Not estimable due to insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '80.4'}, {'value': '77.8', 'groupId': 'OG001', 'lowerLimit': '36.5', 'upperLimit': '93.9'}, {'value': '66.7', 'groupId': 'OG002', 'lowerLimit': '5.4', 'upperLimit': '94.5'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '80.4'}, {'value': '64.8', 'groupId': 'OG001', 'lowerLimit': '25.3', 'upperLimit': '87.2'}, {'value': '66.7', 'groupId': 'OG002', 'lowerLimit': '5.4', 'upperLimit': '94.5'}]}]}, {'title': '15 months', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '67.6'}, {'value': '51.9', 'groupId': 'OG001', 'lowerLimit': '16.4', 'upperLimit': '78.8'}, {'value': '66.7', 'groupId': 'OG002', 'lowerLimit': '5.4', 'upperLimit': '94.5'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '67.6'}, {'value': '51.9', 'groupId': 'OG001', 'lowerLimit': '16.4', 'upperLimit': '78.8'}, {'value': '66.7', 'groupId': 'OG002', 'lowerLimit': '5.4', 'upperLimit': '94.5'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Not estimable due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '33.3', 'groupId': 'OG002', 'lowerLimit': '0.9', 'upperLimit': '77.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 2.5 years', 'description': "The DOR was defined as the time from the date that the response criteria were first met to the date that progressive disease (PD) was objectively documented or death, whichever occurred first. The event-free rate was estimated by the Kaplan-Meier method with 95% CIs estimated using Greenwood's formula.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab).'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS) As Determined By Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma', 'description': 'Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}, {'id': 'OG001', 'title': 'Relapsed/Refractory Follicular Lymphoma', 'description': 'Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}, {'id': 'OG002', 'title': 'Relapsed/Refractory Marginal Zone Lymphoma', 'description': 'Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.38', 'groupId': 'OG000', 'lowerLimit': '2.69', 'upperLimit': '5.49'}, {'value': '11.10', 'comment': 'NA = Not estimable due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '5.49', 'upperLimit': 'NA'}, {'value': '24.87', 'comment': 'NA = Not estimable due to insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': '11.01', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 2.5 years', 'description': 'The PFS was defined as time from first dose of study treatment until first documentation of progression, assessed per the Lugano Classification, or death, whichever occurred first. Medians were estimated by the Kaplan-Meier method with 95% CIs estimated using the Brookmeyer and Crowley method.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab).'}, {'type': 'SECONDARY', 'title': 'PFS: Event-free Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma', 'description': 'Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}, {'id': 'OG001', 'title': 'Relapsed/Refractory Follicular Lymphoma', 'description': 'Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}, {'id': 'OG002', 'title': 'Relapsed/Refractory Marginal Zone Lymphoma', 'description': 'Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}], 'classes': [{'title': '6 months', 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '37.7'}, {'value': '73.3', 'groupId': 'OG001', 'lowerLimit': '43.3', 'upperLimit': '89.1'}, {'value': '100.0', 'comment': 'NA = Not estimable due to insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '37.7'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '37.5', 'upperLimit': '84.6'}, {'value': '100.0', 'comment': 'NA = Not estimable due to insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '37.7'}, {'value': '46.7', 'groupId': 'OG001', 'lowerLimit': '21.2', 'upperLimit': '68.7'}, {'value': '80.0', 'groupId': 'OG002', 'lowerLimit': '20.4', 'upperLimit': '96.9'}]}]}, {'title': '15 months', 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '37.7'}, {'value': '46.7', 'groupId': 'OG001', 'lowerLimit': '21.2', 'upperLimit': '68.7'}, {'value': '60.0', 'groupId': 'OG002', 'lowerLimit': '12.6', 'upperLimit': '88.2'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '30.7'}, {'value': '40.0', 'groupId': 'OG001', 'lowerLimit': '16.5', 'upperLimit': '62.8'}, {'value': '60.0', 'groupId': 'OG002', 'lowerLimit': '12.6', 'upperLimit': '88.2'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '30.7'}, {'value': '40.0', 'groupId': 'OG001', 'lowerLimit': '16.5', 'upperLimit': '62.8'}, {'value': '60.0', 'groupId': 'OG002', 'lowerLimit': '12.6', 'upperLimit': '88.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 2.5 years', 'description': "The PFS was defined as time from first dose of study treatment until first documentation of progression, assessed per the Lugano Classification, or death, whichever occurred first. The event-free rate was estimated by the Kaplan-Meier method with 95% CIs estimated using Greenwood's formula.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab).'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma', 'description': 'Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance.'}, {'id': 'OG001', 'title': 'Relapsed/Refractory Follicular Lymphoma', 'description': 'Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}, {'id': 'OG002', 'title': 'Relapsed/Refractory Marginal Zone Lymphoma', 'description': 'Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.20', 'groupId': 'OG000', 'lowerLimit': '5.39', 'upperLimit': '24.44'}, {'value': 'NA', 'comment': 'NA = Not estimable due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Not estimable due to insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 2.5 years', 'description': 'The OS was defined as the time from the date of first dose of study treatment to the date of death due to any cause. Medians were estimated by the Kaplan-Meier method with 95% CIs estimated using the method of Brookmeyer and Crowley.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab).'}, {'type': 'SECONDARY', 'title': 'OS: Survival Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma', 'description': 'Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance.'}, {'id': 'OG001', 'title': 'Relapsed/Refractory Follicular Lymphoma', 'description': 'Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance.'}, {'id': 'OG002', 'title': 'Relapsed/Refractory Marginal Zone Lymphoma', 'description': 'Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}], 'classes': [{'title': '6 months', 'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000', 'lowerLimit': '46.3', 'upperLimit': '87.6'}, {'value': '93.3', 'groupId': 'OG001', 'lowerLimit': '61.3', 'upperLimit': '99.0'}, {'value': '100.0', 'comment': 'NA = Not estimable due to insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '55.9', 'groupId': 'OG000', 'lowerLimit': '30.8', 'upperLimit': '75.0'}, {'value': '93.3', 'groupId': 'OG001', 'lowerLimit': '61.3', 'upperLimit': '99.0'}, {'value': '100.0', 'comment': 'NA = Not estimable due to insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '44.7', 'groupId': 'OG000', 'lowerLimit': '21.8', 'upperLimit': '65.4'}, {'value': '93.3', 'groupId': 'OG001', 'lowerLimit': '61.3', 'upperLimit': '99.0'}, {'value': '100.0', 'comment': 'NA = Not estimable due to insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '15 months', 'categories': [{'measurements': [{'value': '33.6', 'groupId': 'OG000', 'lowerLimit': '13.8', 'upperLimit': '54.8'}, {'value': '93.3', 'groupId': 'OG001', 'lowerLimit': '61.3', 'upperLimit': '99.0'}, {'value': '100.0', 'comment': 'NA = Not estimable due to insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '33.6', 'groupId': 'OG000', 'lowerLimit': '13.8', 'upperLimit': '54.8'}, {'value': '93.3', 'groupId': 'OG001', 'lowerLimit': '61.3', 'upperLimit': '99.0'}, {'value': '100.0', 'comment': 'NA = Not estimable due to insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '33.6', 'groupId': 'OG000', 'lowerLimit': '13.8', 'upperLimit': '54.8'}, {'value': '93.3', 'groupId': 'OG001', 'lowerLimit': '61.3', 'upperLimit': '99.0'}, {'value': '100.0', 'comment': 'NA = Not estimable due to insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 2.5 years', 'description': "The OS was defined as the time from the date of first dose of study treatment to the date of death due to any cause. Survival rates were estimated by the Kaplan-Meier method with 95% CIs estimated using Greenwood's formula.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab).'}, {'type': 'SECONDARY', 'title': 'Time To Response (TTR) As Determined By The Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma', 'description': 'Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance.'}, {'id': 'OG001', 'title': 'Relapsed/Refractory Follicular Lymphoma', 'description': 'Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance.'}, {'id': 'OG002', 'title': 'Relapsed/Refractory Marginal Zone Lymphoma', 'description': 'Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.56', 'spread': '2.054', 'groupId': 'OG000'}, {'value': '6.15', 'spread': '3.867', 'groupId': 'OG001'}, {'value': '3.67', 'spread': '1.631', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to approximately 2.5 years', 'description': 'The TTR was defined as the time from the date of the first dose of study treatment to the date of the first qualifying response (partial response or better).', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab).'}, {'type': 'SECONDARY', 'title': 'Median TTR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma', 'description': 'Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance.'}, {'id': 'OG001', 'title': 'Relapsed/Refractory Follicular Lymphoma', 'description': 'Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance.'}, {'id': 'OG002', 'title': 'Relapsed/Refractory Marginal Zone Lymphoma', 'description': 'Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.79', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '8.2'}, {'value': '5.49', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '13.8'}, {'value': '2.73', 'groupId': 'OG002', 'lowerLimit': '2.7', 'upperLimit': '5.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 2.5 years', 'description': 'The TTR was defined as the time from the date of the first dose of study treatment to the date of the first qualifying response (partial response or better).', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab).'}, {'type': 'SECONDARY', 'title': 'Complete Response Rate As Determined By The Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma', 'description': 'Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance.'}, {'id': 'OG001', 'title': 'Relapsed/Refractory Follicular Lymphoma', 'description': 'Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance.'}, {'id': 'OG002', 'title': 'Relapsed/Refractory Marginal Zone Lymphoma', 'description': 'Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '31.7'}, {'value': '18.8', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '45.6'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '52.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 2.5 years', 'description': 'The percentage of participants whose best overall response met complete response or complete metabolic response criteria among all participants are reported. The 95% CI was calculated with Clopper-Pearson method.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab).'}, {'type': 'SECONDARY', 'title': 'Number Of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) And Serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma', 'description': 'Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance.'}, {'id': 'OG001', 'title': 'Relapsed/Refractory Follicular Lymphoma', 'description': 'Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance.'}, {'id': 'OG002', 'title': 'Relapsed/Refractory Marginal Zone Lymphoma', 'description': 'Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance.'}], 'classes': [{'title': 'Participants With at Least 1 TEAE', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 2.5 years', 'description': 'A treatment-emergent adverse event was defined as an adverse event with an onset or worsening (if present pretreatment) starting on or after the first dose of study drug up to 30 days after discontinuation of zanubrutinib or 90 days after discontinuation of rituximab, whichever occurred later; or initiation of new anticancer therapy if it occurred prior to the other 2 dates. Worsening of a treatment-emergent adverse event to Grade 5 beyond Day 30 after the last dose of zanubrutinib or Day 90 after the last dose rituximab was also considered a treatment-emergent adverse event if the event occurred prior to initiation of new anticancer therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma', 'description': 'Participants with relapsed/refractory (R/R) non-germinal center B-cell-like diffuse large B-cell lymphoma (non-GCB DLBCL) received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 milligrams (mg) orally (PO) twice daily (BID) continuously and rituximab 375 mg/meter squared (m\\^2) intravenously (IV) on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}, {'id': 'FG001', 'title': 'Relapsed/Refractory Follicular Lymphoma', 'description': 'Participants with R/R follicular lymphoma (FL) received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}, {'id': 'FG002', 'title': 'Relapsed/Refractory Marginal Zone Lymphoma', 'description': 'Participants with R/R marginal zone lymphoma (MZL) received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Study Terminated by the Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'This study was conducted at 4 study centers in China, all of which enrolled participants. The first enrolled participants received their first dose on 04 January 2018, and the last participant enrolled received their first dose on 20 December 2018. A total of 41 participants with non-Hodgkin lymphoma (NHL) were enrolled into the study, and all received ≥1 dose of study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma', 'description': 'Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}, {'id': 'BG001', 'title': 'Relapsed/Refractory Follicular Lymphoma', 'description': 'Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}, {'id': 'BG002', 'title': 'Relapsed/Refractory Marginal Zone Lymphoma', 'description': 'Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.2', 'spread': '15.00', 'groupId': 'BG000'}, {'value': '47.6', 'spread': '12.36', 'groupId': 'BG001'}, {'value': '61.2', 'spread': '8.87', 'groupId': 'BG002'}, {'value': '53.0', 'spread': '13.94', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '23.43', 'spread': '2.652', 'groupId': 'BG000'}, {'value': '25.04', 'spread': '5.079', 'groupId': 'BG001'}, {'value': '24.33', 'spread': '4.813', 'groupId': 'BG002'}, {'value': '24.17', 'spread': '3.989', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Surface Area', 'classes': [{'categories': [{'measurements': [{'value': '1.72', 'spread': '0.113', 'groupId': 'BG000'}, {'value': '1.77', 'spread': '0.295', 'groupId': 'BG001'}, {'value': '1.69', 'spread': '0.240', 'groupId': 'BG002'}, {'value': '1.74', 'spread': '0.213', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'm^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Eastern Cooperative Oncology Group Performance (ECOG)Status', 'classes': [{'title': 'Grade 0', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}, {'title': 'Grade 1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ECOG Performance Status - Grade 0 = Fully active, able to carry on all pre-disease performance without restriction; Grade 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg, light house work, office work; Grade 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours', 'unitOfMeasure': 'Participants'}, {'title': 'Hepatitis B Core Antibody', 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-28', 'size': 1227755, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-26T10:20', 'hasProtocol': True}, {'date': '2020-09-11', 'size': 613661, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-26T10:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2018-04-28', 'resultsFirstSubmitDate': '2021-08-26', 'studyFirstSubmitQcDate': '2018-04-28', 'lastUpdatePostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-26', 'studyFirstPostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR) As Measured By The Investigator', 'timeFrame': 'Up to approximately 2.5 years', 'description': 'The percentage of participants whose best overall response met partial response (PR) or complete response (CR) criteria among all participants. The 95% confidence interval (CI) was calculated with the Clopper-Pearson method.'}], 'secondaryOutcomes': [{'measure': 'Duration Of Response (DOR) As Determined By Investigator', 'timeFrame': 'Up to approximately 2.5 years', 'description': 'The DOR was defined as the time from the date that the response criteria were first met to the date that progressive disease (PD) was objectively documented or death, whichever occurred first. Medians were estimated by the Kaplan-Meier method with 95% CIs estimated using the Brookmeyer and Crowley method.'}, {'measure': 'DOR: Event-free Rate', 'timeFrame': 'Up to approximately 2.5 years', 'description': "The DOR was defined as the time from the date that the response criteria were first met to the date that progressive disease (PD) was objectively documented or death, whichever occurred first. The event-free rate was estimated by the Kaplan-Meier method with 95% CIs estimated using Greenwood's formula."}, {'measure': 'Progression-free Survival (PFS) As Determined By Investigator', 'timeFrame': 'Up to approximately 2.5 years', 'description': 'The PFS was defined as time from first dose of study treatment until first documentation of progression, assessed per the Lugano Classification, or death, whichever occurred first. Medians were estimated by the Kaplan-Meier method with 95% CIs estimated using the Brookmeyer and Crowley method.'}, {'measure': 'PFS: Event-free Rate', 'timeFrame': 'Up to approximately 2.5 years', 'description': "The PFS was defined as time from first dose of study treatment until first documentation of progression, assessed per the Lugano Classification, or death, whichever occurred first. The event-free rate was estimated by the Kaplan-Meier method with 95% CIs estimated using Greenwood's formula."}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 2.5 years', 'description': 'The OS was defined as the time from the date of first dose of study treatment to the date of death due to any cause. Medians were estimated by the Kaplan-Meier method with 95% CIs estimated using the method of Brookmeyer and Crowley.'}, {'measure': 'OS: Survival Rate', 'timeFrame': 'Up to approximately 2.5 years', 'description': "The OS was defined as the time from the date of first dose of study treatment to the date of death due to any cause. Survival rates were estimated by the Kaplan-Meier method with 95% CIs estimated using Greenwood's formula."}, {'measure': 'Time To Response (TTR) As Determined By The Investigator', 'timeFrame': 'Up to approximately 2.5 years', 'description': 'The TTR was defined as the time from the date of the first dose of study treatment to the date of the first qualifying response (partial response or better).'}, {'measure': 'Median TTR', 'timeFrame': 'Up to approximately 2.5 years', 'description': 'The TTR was defined as the time from the date of the first dose of study treatment to the date of the first qualifying response (partial response or better).'}, {'measure': 'Complete Response Rate As Determined By The Investigator', 'timeFrame': 'Up to approximately 2.5 years', 'description': 'The percentage of participants whose best overall response met complete response or complete metabolic response criteria among all participants are reported. The 95% CI was calculated with Clopper-Pearson method.'}, {'measure': 'Number Of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) And Serious TEAEs', 'timeFrame': 'Up to approximately 2.5 years', 'description': 'A treatment-emergent adverse event was defined as an adverse event with an onset or worsening (if present pretreatment) starting on or after the first dose of study drug up to 30 days after discontinuation of zanubrutinib or 90 days after discontinuation of rituximab, whichever occurred later; or initiation of new anticancer therapy if it occurred prior to the other 2 dates. Worsening of a treatment-emergent adverse event to Grade 5 beyond Day 30 after the last dose of zanubrutinib or Day 90 after the last dose rituximab was also considered a treatment-emergent adverse event if the event occurred prior to initiation of new anticancer therapy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Marginal Zone Lymphoma', 'Follicular Lymphoma', 'Diffuse Large B-Cell Lymphoma']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Qingyuan Zhang, Rong Tao, Zhenyu Li, et al. Zanubrutinib (BGB-3111) in combination with rituximab in patients with relapsed/refractory Non-Hodgkin Lymphoma [EHA-2188].'}]}, 'descriptionModule': {'briefSummary': 'This was a multicenter, open-label, phase 2 study to evaluate efficacy, safety, and tolerability of BGB-3111 (zanubrutinib) 160 milligrams (mg) twice daily (BID) in combination with rituximab in Chinese participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) (non-GCB \\[non-germinal center B-cell-like\\] subtype) and R/R indolent lymphoma (follicular lymphoma \\[FL\\] and marginal zone lymphoma \\[MZL\\]).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. ≥ Age 18 years at time of signing of informed consent.\n2. Measurable disease by computed tomography (CT) or positron emission tomography/CT or magnetic resonance imaging, defined as ≥1 nodal lesion that was \\>1.5 centimeters (cm) in the longest diameter, or ≥1 extra-nodal lesion (for example, hepatic nodules) that was \\>1 cm in the longest diameter.\n3. Availability of archival or fresh tumor tissue sample from an evaluable core or excisional biopsy.\n4. Participants meet the following criteria:\n\n 1. Cohort 1: R/R non-GCB DLBCL i. Histologically confirmed non-GCB DLBCL per Hans criteria with non-transformed disease; additional methodologies for confirming non-GCB DLBCL may have been considered in consultation with the medical monitor. ii. Relapsed disease (disease progression after most recent therapy for DLBCL occurring more than 6 months after the completion of last therapy) or refractory disease (failure to achieve complete response \\[CR\\] or partial response \\[PR\\] to therapy for non-GCB DLBCL or disease progression within 6 months after completion of the most recent therapy for non-GCB DLBCL). iii. Must have received at least one standard anthracycline ± rituximab-based treatment (for example, rituximab plus cyclophosphamide, doxorubicin \\[or epirubicin, hydroxydaunorubicin, or similar\\], vincristine, and prednisone) or cyclophosphamide, vincristine, and prednisone +/- rituximab for DLBCL.\n 2. Cohort 2: R/R FL or R/R MZL i. Histologically confirmed CD20+ FL (Grade 1, 2, or 3a) or MZL. ii. Relapsed disease (disease progression after most recent therapy for FL or MZL occurring more than 6 months after the completion of last therapy) or refractory disease (failure to achieve complete response (CR) or partial response (PR) to most recent therapy for FL or MZL, or disease progression within 6 months after completion of the most recent therapy for FL or MZL).\n5. Laboratory parameters as specified below:\n\n 1. Hematologic: Platelet count ≥75 x 10\\^9/liter (L) independent of growth factor or transfusion within 7 days of study entry; absolute neutrophil count (ANC) ≥1 x 10\\^9/L independent of growth factor within 7 days of study entry, hemoglobin \\>8 grams/deciliter within 7 days of study entry.\n 2. Hepatic: Total bilirubin ≤ 2x upper limit of normal (ULN) unless documented Gilbert's syndrome; aspartate aminotransferase/serum glutamic-oxaloacetic transaminase and alanine transaminase/serum glutamic-pyruvic transaminase ≤3x ULN.\n 3. Renal: Creatinine clearance ≥30 milliliters/minute (as estimated by the Cockcroft-Gault equation based on ideal body weight or as measured by nuclear medicine scan or 24-hour urine collection).\n 4. International normalized ratio and activated partial thromboplastin time ≤1.5x ULN. Participants with anti-phospholipid syndrome, acquired von Willebrand disease, factor inhibitors or on vitamin K antagonist may have been enrolled after discussion with the Medical Monitor.\n6. Left ventricular ejection fraction ≥50%.\n7. Life expectancy ≥6 months.\n8. Eastern Cooperative Oncology Group performance status of 0, 1, or 2.\n9. Female participants of childbearing potential must have practiced highly effective methods of contraception initiated prior to first dose of study drug, for the duration of the study, and for ≥90 days after the last dose of zanubrutinib, or 12 months after the last dose of rituximab, whichever is longer.\n10. Male participants were eligible if vasectomized or if they agreed to the use of barrier contraception in combination with other methods above during the study treatment period and for ≥90 days after the last dose of zanubrutinib.\n11. Able to provide written informed consent and could understand and comply with the requirements of the study.\n\nKey Exclusion Criteria:\n\n1. Known central nervous system lymphoma or leukemia.\n2. Histological confirmed gastric mucosa-associated lymphoid tissue type MZL.\n3. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.\n4. Clinically significant cardiovascular disease.\n5. History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention.\n6. History of stroke or intracranial hemorrhage within 6 months before first dose of study drug.\n7. Severe or debilitating pulmonary disease.\n8. Hypersensitivity reaction to zanubrutinib or rituximab or any of the other ingredients of the study drugs.\n9. Prior Bruton tyrosine kinase inhibitor treatment.\n10. Required ongoing treatment with a strong cytochrome P450 protein inhibitor or inducer.\n11. Vaccination with a live vaccine within 28 days of the first dose of study drug.\n12. Hematopoietic stem cell transplantation within 6 months of first dose of study drug.\n13. Receipt of the following treatment prior to first dose of study drug:\n\n 1. Corticosteroids at doses \\>20 mg/day prednisone equivalent or steroids given with anti-neoplastic intent within 7 days prior to first dose of study drug.\n 2. Chemotherapy or radiotherapy within 4 weeks.\n 3. Monoclonal antibody within 4 weeks.\n 4. Investigational therapy within 4 weeks.\n 5. Chinese patent medicine with anti-neoplastic intent within 4 weeks.\n14. Not recovered from toxicity of any prior anti-cancer therapy to ≤Grade 1, except for alopecia, ANC, hemoglobin (Hgb), and platelets. For ANC, Hgb and platelets, see inclusion criterion #5.\n15. Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast.\n16. Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, history of bariatric surgery, or partial or complete bowel obstruction.\n17. Major surgery within 4 weeks prior to first dose of study treatment.\n18. Active fungal, bacterial and/or viral infection requiring systemic therapy.\n19. Known infection with human immunodeficiency virus, or serologic status reflecting active hepatitis B or C infection as follows:\n\n 1. Presence of hepatitis B surface antigen (HBsAg) or anti-hepatitis B core antibody (anti-HBc). Participants with presence of anti-HBc, but absence of HBsAg, were eligible if hepatitis B virus (HBV) DNA was \\<500 international units (IU)/mL, anti-viral therapy started before the first dose of study treatment, and if they were willing to undergo monthly monitoring for HBV reactivation.\n 2. Presence of hepatitis C virus (HCV) antibody. Participants with presence of HCV antibody were eligible if HCV RNA was undetectable (\\<15 IU/mL).\n20. Pregnant or lactating women.\n21. Underlying medical conditions that, in the investigator's opinion, would have rendered the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events.\n22. Concurrent participation in another therapeutic clinical trial.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may have applied."}, 'identificationModule': {'nctId': 'NCT03520920', 'briefTitle': 'BTK Inhibitor BGB-3111 in Chinese Participants With Diffuse Large B-Cell Lymphoma (Non-GCB) and Indolent Lymphoma (FL and MZL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'BeiGene'}, 'officialTitle': 'A Phase 2 Study to Assess the Safety, Tolerability, and Activity of BGB-3111 in Combination With Rituximab in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (Non-GCB Subtype) and Relapsed/Refractory Indolent Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)', 'orgStudyIdInfo': {'id': 'BGB-3111-213'}, 'secondaryIdInfos': [{'id': 'CTR20170965', 'type': 'REGISTRY', 'domain': 'China Drug Trials (CDT)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'R/R Non-GCB DLBCL', 'description': 'Participants with non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance.', 'interventionNames': ['Drug: Zanubrutinib', 'Drug: Rituximab']}, {'type': 'EXPERIMENTAL', 'label': 'R/R FL or MZL', 'description': 'Participants with R/R FL or MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance.', 'interventionNames': ['Drug: Zanubrutinib', 'Drug: Rituximab']}], 'interventions': [{'name': 'Zanubrutinib', 'type': 'DRUG', 'otherNames': ['BGB-3111'], 'description': 'Administered zanubrutinib 160 mg orally (PO) BID continuously', 'armGroupLabels': ['R/R FL or MZL', 'R/R Non-GCB DLBCL']}, {'name': 'Rituximab', 'type': 'DRUG', 'description': 'Administered rituximab 375 mg/m\\^2 intravenously on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.', 'armGroupLabels': ['R/R FL or MZL', 'R/R Non-GCB DLBCL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '150000', 'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'Harbin Medical University Cancer Hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '221000', 'city': 'Xuzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The Affiliated Hospital of Xuzhou Medical University', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'zip': '200092', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BeiGene'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BeiGene', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}