Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-03-01 @ 3:52 PM
Study NCT ID:
NCT02343120
Status:
COMPLETED
Last Update Posted:
2022-04-28
First Post:
2015-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629551', 'term': 'zanubrutinib'}]}}, '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': 'Up to 6 years and 7 months', 'description': 'One participant in the 320 mg QD group discontinued the study for Other reasons, as shown in the participant flow section, and subsequently died after study discontinuation. That participant is counted under all-cause mortality in this section.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: 40 mg QD', 'description': 'Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Part 1: 80 mg QD', 'description': 'Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Part 1: 160 mg QD', 'description': 'Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 2, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Part 1 and Part 2: 160 mg BID', 'description': 'Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.', 'otherNumAtRisk': 278, 'deathsNumAtRisk': 278, 'otherNumAffected': 273, 'seriousNumAtRisk': 278, 'deathsNumAffected': 76, 'seriousNumAffected': 157}, {'id': 'EG004', 'title': 'Part 1 and Part 2: 320 mg QD', 'description': 'Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.', 'otherNumAtRisk': 95, 'deathsNumAtRisk': 95, 'otherNumAffected': 94, 'seriousNumAtRisk': 95, 'deathsNumAffected': 19, 'seriousNumAffected': 45}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 64, 'numAffected': 39}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 16, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Increased tendency to bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 107, 'numAffected': 44}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 29, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Spontaneous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 42, 'numAffected': 25}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 24, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 59, 'numAffected': 50}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 29, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 122, 'numAffected': 77}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 36, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 27, 'numAffected': 24}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Mouth haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Renal artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 0, 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Obstructive airways disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 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23.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 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'EG003', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 23.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1 and Part 2: Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '278', 'groupId': 'OG003'}, {'value': '95', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 40 mg QD', 'description': 'Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG001', 'title': 'Part 1: 80 mg QD', 'description': 'Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG002', 'title': 'Part 1: 160 mg QD', 'description': 'Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG003', 'title': 'Parts 1 and 2: 160 mg BID', 'description': 'Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}, {'id': 'OG004', 'title': 'Parts 1 and 2: 320 mg QD', 'description': 'Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}], 'classes': [{'title': 'At least one treatment-emergent adverse event', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '274', 'groupId': 'OG003'}, {'value': '94', 'groupId': 'OG004'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '157', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 6 years and 7 months', 'description': 'Number of participants with adverse events and serious adverse events, including clinically relevant physical examinations and laboratory measurements', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set included all participants who received ≥ 1 dose of study drug'}, {'type': 'PRIMARY', 'title': 'Part 1: Recommended Phase 2 Dose (RP2D) for Zanubrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Zanubrutinib', 'description': 'Five dose regimens of zanubrutinib (40 mg QD, 80 mg QD, 160 mg QD, 160 mg BID, and 320 mg QD) were evaluated.'}], 'classes': [{'categories': [{'measurements': [{'value': '320', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 9', 'description': 'RP2D for zanubrutinib was the maximum tolerated dose (MTD) or less, which was determined by testing increasing doses up to 320 mg QD', 'unitOfMeasure': 'milligrams', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set included all participants who received ≥ 1 dose of study drug'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Area Under the Curve From Time 0 to the Last Sampling Time Point Within the Dose Interval (AUClast) of Zanubrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 40 mg QD', 'description': 'Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG001', 'title': 'Part 1: 80 mg QD', 'description': 'Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG002', 'title': 'Part 1: 160 mg QD', 'description': 'Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG003', 'title': 'Parts 1 and 2: 160 mg BID', 'description': 'Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}, {'id': 'OG004', 'title': 'Parts 1 and 2: 320 mg QD', 'description': 'Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}], 'classes': [{'categories': [{'measurements': [{'value': '274.7', 'spread': '47.8', 'groupId': 'OG000'}, {'value': '436.8', 'spread': '103.5', 'groupId': 'OG001'}, {'value': '1480', 'spread': '53.0', 'groupId': 'OG002'}, {'value': '1132', 'spread': '61.1', 'groupId': 'OG003'}, {'value': '2281', 'spread': '60.5', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours', 'unitOfMeasure': 'nanograms/milliliters*hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Area Under the Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Zanubrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 40 mg QD', 'description': 'Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG001', 'title': 'Part 1: 80 mg QD', 'description': 'Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG002', 'title': 'Part 1: 160 mg QD', 'description': 'Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG003', 'title': 'Part 1 and Part 2: 160 mg BID', 'description': 'Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}, {'id': 'OG004', 'title': 'Part 1 and Part 2: 320 mg QD', 'description': 'Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}], 'classes': [{'categories': [{'measurements': [{'value': '301.1', 'spread': '51.5', 'groupId': 'OG000'}, {'value': '460.0', 'spread': '100.6', 'groupId': 'OG001'}, {'value': '1505', 'spread': '52.7', 'groupId': 'OG002'}, {'value': '1253', 'spread': '59.0', 'groupId': 'OG003'}, {'value': '2538', 'spread': '47.8', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours', 'unitOfMeasure': 'nanograms/milliliters*hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) After Administration of Zanubrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 40 mg QD', 'description': 'Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG001', 'title': 'Part 1: 80 mg QD', 'description': 'Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG002', 'title': 'Part 1: 160 mg QD', 'description': 'Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to'}, {'id': 'OG003', 'title': 'Part 1 and Part 2: 160 mg BID', 'description': 'Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}, {'id': 'OG004', 'title': 'Part 1 and Part 2: 320 mg QD', 'description': 'Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}], 'classes': [{'categories': [{'measurements': [{'value': '86.0', 'spread': '46.6', 'groupId': 'OG000'}, {'value': '125', 'spread': '77.6', 'groupId': 'OG001'}, {'value': '397', 'spread': '76.1', 'groupId': 'OG002'}, {'value': '304', 'spread': '63.8', 'groupId': 'OG003'}, {'value': '566', 'spread': '65.6', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours', 'unitOfMeasure': 'nanograms/milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) After Administration of Zanubrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 40 mg QD', 'description': 'Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG001', 'title': 'Part 1: 80 mg QD', 'description': 'Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG002', 'title': 'Part 1: 160 mg QD', 'description': 'Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG003', 'title': 'Part 1 and Part 2: 160 mg BID', 'description': 'Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}, {'id': 'OG004', 'title': 'Part 1 and Part 2: 320 mg QD', 'description': 'Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.7', 'spread': '36.2', 'groupId': 'OG000'}, {'value': '169', 'spread': '50.0', 'groupId': 'OG001'}, {'value': '387', 'spread': '60.7', 'groupId': 'OG002'}, {'value': '299', 'spread': '56.1', 'groupId': 'OG003'}, {'value': '533', 'spread': '55.0', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 2 Day 1 pre-dose and 24 hours', 'unitOfMeasure': 'nanograms/milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Time to Maximum Observed Plasma Concentration (Tmax) of Zanubrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 40 mg QD', 'description': 'Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG001', 'title': 'Part 1: 80 mg QD', 'description': 'Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG002', 'title': 'Part 1: 160 mg QD', 'description': 'Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG003', 'title': 'Part 1 and Part 2: 160 mg BID', 'description': 'Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}, {'id': 'OG004', 'title': 'Part 1 and Part 2: 320 mg QD', 'description': 'Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '1.98'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.17', 'upperLimit': '2.00'}, {'value': '1.92', 'groupId': 'OG002', 'lowerLimit': '0.93', 'upperLimit': '2.08'}, {'value': '2.00', 'groupId': 'OG003', 'lowerLimit': '0.83', 'upperLimit': '8.00'}, {'value': '2.00', 'groupId': 'OG004', 'lowerLimit': '0.72', 'upperLimit': '3.08'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Time to Maximum Observed Plasma Concentration (Tmax) of Zanubrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 40 mg QD', 'description': 'Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG001', 'title': 'Part 1: 80 mg QD', 'description': 'Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG002', 'title': 'Part 1: 160 mg QD', 'description': 'Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG003', 'title': 'Part 1 and Part 2: 160 mg BID', 'description': 'Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}, {'id': 'OG004', 'title': 'Part 1 and Part 2: 320 mg QD', 'description': 'Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '2.00'}, {'value': '2.50', 'groupId': 'OG001', 'lowerLimit': '1.08', 'upperLimit': '3.00'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '3.17'}, {'value': '2.00', 'groupId': 'OG003', 'lowerLimit': '0.53', 'upperLimit': '6.00'}, {'value': '2.00', 'groupId': 'OG004', 'lowerLimit': '0.33', 'upperLimit': '6.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 2 Day 1 pre-dose and 24 hours', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Apparent Terminal Half-life (t1/2) of Zanubrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 40 mg QD', 'description': 'Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG001', 'title': 'Part 1: 80 mg QD', 'description': 'Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG002', 'title': 'Part 1: 160 mg QD', 'description': 'Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG003', 'title': 'Part 1 and Part 2: 160 mg BID', 'description': 'Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}, {'id': 'OG004', 'title': 'Part 1 and Part 2: 320 mg QD', 'description': 'Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.94', 'spread': '28.5', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '29.8', 'groupId': 'OG001'}, {'value': '3.87', 'spread': '24.9', 'groupId': 'OG002'}, {'value': '2.73', 'spread': '60.2', 'groupId': 'OG003'}, {'value': '3.30', 'spread': '61.2', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours', 'unitOfMeasure': 'Hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Apparent Clearance (CL/F) of Zanubrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 40 mg QD', 'description': 'Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG001', 'title': 'Part 1: 80 mg QD', 'description': 'Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG002', 'title': 'Part 1: 160 mg QD', 'description': 'Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG003', 'title': 'Part 1 and Part 2: 160 mg BID', 'description': 'Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}, {'id': 'OG004', 'title': 'Part 1 and Part 2: 320 mg QD', 'description': 'Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}], 'classes': [{'categories': [{'measurements': [{'value': '133', 'spread': '51.5', 'groupId': 'OG000'}, {'value': '174', 'spread': '100.6', 'groupId': 'OG001'}, {'value': '106', 'spread': '52.7', 'groupId': 'OG002'}, {'value': '128', 'spread': '59.4', 'groupId': 'OG003'}, {'value': '126', 'spread': '47.8', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours', 'unitOfMeasure': 'Liters/hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Apparent Volume of Distribution of Zanubrutinib During the Terminal Phase (Vz/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 40 mg QD', 'description': 'Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG001', 'title': 'Part 1: 80 mg QD', 'description': 'Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG002', 'title': 'Part 1: 160 mg QD', 'description': 'Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG003', 'title': 'Part 1 and Part 2: 160 mg BID', 'description': 'Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}, {'id': 'OG004', 'title': 'Part 1 and Part 2: 320 mg QD', 'description': 'Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}], 'classes': [{'categories': [{'measurements': [{'value': '371', 'spread': '47.5', 'groupId': 'OG000'}, {'value': '494', 'spread': '78.9', 'groupId': 'OG001'}, {'value': '593', 'spread': '61.6', 'groupId': 'OG002'}, {'value': '530', 'spread': '70.0', 'groupId': 'OG003'}, {'value': '600', 'spread': '97.6', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours', 'unitOfMeasure': 'Liters', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 and Part 2: Overall', 'description': 'The dose regimens from Part 1 (40 mg, 80 mg, 160 mg QD, 160 mg BID and 320 mg QD) and Part 2 (160 mg BID and 320 mg QD) were evaluated in different disease types. Efficacy evaluations are reported by disease type for Parts 1 and 2 combined, as pre-specified in the statistical analysis plan.'}], 'classes': [{'title': 'CLL/SLL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.2', 'groupId': 'OG000', 'lowerLimit': '89.8', 'upperLimit': '98.2'}]}]}, {'title': 'WM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000', 'lowerLimit': '88.5', 'upperLimit': '99.1'}]}]}, {'title': 'MCL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.5', 'groupId': 'OG000', 'lowerLimit': '70.1', 'upperLimit': '91.3'}]}]}, {'title': 'MZL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.0', 'groupId': 'OG000', 'lowerLimit': '62.1', 'upperLimit': '96.8'}]}]}, {'title': 'FL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '20.4', 'upperLimit': '54.9'}]}]}, {'title': 'DLBCL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.2', 'groupId': 'OG000', 'lowerLimit': '27.7', 'upperLimit': '57.8'}]}]}, {'title': 'RT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000', 'lowerLimit': '31.6', 'upperLimit': '86.1'}]}]}, {'title': 'HCL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58.3', 'groupId': 'OG000', 'lowerLimit': '27.7', 'upperLimit': '84.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 years and 7 months', 'description': "ORR is defined as the percentage of participants with partial or complete response (CR), as assessed by the investigator. For CLL/SLL, ORR includes partial response (PR) with lymphocytosis (PR-L) or better (includes PR-L, PR, nodular PR or nPR and CR with incomplete marrow recovery or CRi) and for MW, ORR includes minor response or better. Efficacy results are reported for each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL).", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Evaluable Set consists of all participants who received at least one dose of zanubrutinib; for WM, participants also must have a baseline IgM (or M-protein) ≥ 5 g/L and no prior exposure to a BTK inhibitor.'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Complete Response Rate (CRR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 and Part 2: Overall', 'description': 'The dose regimens from Part 1 (40 mg, 80 mg, 160 mg QD, 160 mg BID and 320 mg QD) and Part 2 (160 mg BID and 320 mg QD) were evaluated in different disease types. Efficacy evaluations are reported by disease type for Parts 1 and 2 combined, as pre-specified in the statistical analysis plan.'}], 'classes': [{'title': 'CLL/SLL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '24.5'}]}]}, {'title': 'WM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.6', 'groupId': 'OG000', 'lowerLimit': '34.8', 'upperLimit': '58.6'}]}]}, {'title': 'MCL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.1', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': '41.5'}]}]}, {'title': 'MZL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '43.7'}]}]}, {'title': 'FL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '35.5'}]}]}, {'title': 'DLBCL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.4', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '39.5'}]}]}, {'title': 'RT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '45.4'}]}]}, {'title': 'HCL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '48.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 years and 7 months', 'description': "CRR is defined as the percentage of participants who achieve a complete response, as assessed by the investigator. For CLL/SLL, CRR includes CRi or better. For WM, CRR includes very good partial response (VGPR) or better. Efficacy results are reported for each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL).", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Evaluable Set consists of all participants who received at least one dose of zanubrutinib; for WM, participants also must have a baseline IgM (or M-protein) ≥ 5 g/L and no prior exposure to a BTK inhibitor.'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Partial Response (PR) or Better', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 and Part 2: Overall', 'description': 'The dose regimens from Part 1 (40 mg, 80 mg, 160 mg QD, 160 mg BID and 320 mg QD) and Part 2 (160 mg BID and 320 mg QD) were evaluated in different disease types. Efficacy evaluations are reported by disease type for Parts 1 and 2 combined, as pre-specified in the statistical analysis plan.'}], 'classes': [{'title': 'CLL/SLL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.0', 'groupId': 'OG000', 'lowerLimit': '85.8', 'upperLimit': '96.1'}]}]}, {'title': 'WM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.2', 'groupId': 'OG000', 'lowerLimit': '71.5', 'upperLimit': '90.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 years and 7 months', 'description': 'PR or better is defined as the percentage of participants who achieve a partial response or better, as assessed by the investigator. For CLL/SLL, includes PR, nPR, CRi, CR and for WM includes PR, VGPR, and CR. Efficacy results are reported for the B-cell malignancy subtypes chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and Waldenström macroglobulinemia (WM).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Evaluable Set consists of all participants who received at least one dose of zanubrutinib; for WM, participants also must have a baseline IgM (or M-protein) ≥ 5 g/L and no prior exposure to a BTK inhibitor.'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 and Part 2: Overall', 'description': 'The dose regimens from Part 1 (40 mg, 80 mg, 160 mg QD, 160 mg BID and 320 mg QD) and Part 2 (160 mg BID and 320 mg QD) were evaluated in different disease types. Efficacy evaluations are reported by disease type for Parts 1 and 2 combined, as pre-specified in the statistical analysis plan.'}], 'classes': [{'title': 'CLL/SLL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61.4', 'comment': 'Data not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '55.2', 'upperLimit': 'NA'}]}]}, {'title': 'WM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '48.9', 'upperLimit': 'NA'}]}]}, {'title': 'MCL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.6', 'groupId': 'OG000', 'lowerLimit': '15.4', 'upperLimit': '45.5'}]}]}, {'title': 'MZL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '17.1', 'upperLimit': 'NA'}]}]}, {'title': 'FL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '22.9'}]}]}, {'title': 'DLBCL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '5.6'}]}]}, {'title': 'RT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.3', 'comment': 'Data not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': 'NA'}]}]}, {'title': 'HCL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '28.7', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 6 years and 7 months', 'description': "PFS is defined as the time from the first dose date of study drug to the date of the earliest occurrence of progressive disease or death due to any cause, whichever occurs first. Efficacy results are reported for each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL).", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Evaluable Set consists of all participants who received at least one dose of zanubrutinib; for WM, participants also must have a baseline IgM (or M-protein) ≥ 5 g/L and no prior exposure to a BTK inhibitor.'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 and Part 2: Overall', 'description': 'The dose regimens from Part 1 (40 mg, 80 mg, 160 mg QD, 160 mg BID and 320 mg QD) and Part 2 (160 mg BID and 320 mg QD) were evaluated in different disease types. Efficacy evaluations are reported by disease type for Parts 1 and 2 combined, as pre-specified in the statistical analysis plan.'}], 'classes': [{'title': 'CLL/SLL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'WM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'MCL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '27.2', 'upperLimit': 'NA'}]}]}, {'title': 'MZL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '37.3', 'upperLimit': 'NA'}]}]}, {'title': 'DLBCL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '24.8'}]}]}, {'title': 'RT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.3', 'comment': 'Data not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': 'NA'}]}]}, {'title': 'HCL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '26.6', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 6 years and 7 months', 'description': "OS is defined as the time from the date of the first dose to death due to any cause. Efficacy results are reported for each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL).", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Evaluable Set consists of all participants who received at least one dose of zanubrutinib; for WM, participants also must have a baseline IgM (or M-protein) ≥ 5 g/L and no prior exposure to a BTK inhibitor.'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 and Part 2: Overall', 'description': 'The dose regimens from Part 1 (40 mg, 80 mg, 160 mg QD, 160 mg BID and 320 mg QD) and Part 2 (160 mg BID and 320 mg QD) were evaluated in different disease types. Efficacy evaluations are reported by disease type for Parts 1 and 2 combined, as pre-specified in the statistical analysis plan.'}], 'classes': [{'title': 'CLL/SLL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58.6', 'comment': 'Data not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '52.6', 'upperLimit': 'NA'}]}]}, {'title': 'WM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '31.34', 'upperLimit': 'NA'}]}]}, {'title': 'MCL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.2', 'comment': 'Data not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '16.2', 'upperLimit': 'NA'}]}]}, {'title': 'MZL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': 'NA'}]}]}, {'title': 'FL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': 'NA'}]}]}, {'title': 'DLBCL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.2', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '26.2'}]}]}, {'title': 'RT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.9', 'comment': 'Data not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': 'NA'}]}]}, {'title': 'HCL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 6 years and 7 months', 'description': "DOR for responders is defined as time from the date of the earliest qualifying response to the date of progressive disease or death for any cause, whichever occurs earlier. Efficacy results are reported for responders (defined as PR or better, except CLL/SLL and WM) in each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL; PR with lymphocytosis or better), Waldenstrom macroglobulinemia (WM; minor response or better), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL).", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Evaluable Set consists of all participants who received at least one dose of zanubrutinib; for WM, participants also must have a baseline IgM (or M-protein) ≥ 5 g/L and no prior exposure to a BTK inhibitor.'}, {'type': 'SECONDARY', 'title': "Number of Participants With Greater Than 75% Bruton's Tyrosine Kinase (BTK) Occupancy", 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 40 mg QD', 'description': 'Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG001', 'title': 'Part 1: 80 mg QD', 'description': 'Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG002', 'title': 'Part 1: 160 mg QD', 'description': 'Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'OG003', 'title': 'Part 1 and Part 2: 160 mg BID', 'description': 'Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up were evaluated. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}, {'id': 'OG004', 'title': 'Part 1 and Part 2: 320 mg QD', 'description': 'Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up were evaluated. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1 Day 1 (W1D1) predose, W1D1 4 hours, W1D2 24 hours, W1D3 predose, and W2D1 predose', 'description': 'Number of participants with greater than 75% BTK occupancy of zanubrutinib in peripheral blood mononuclear cells (PBMCs)', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic analysis set consisted of participants in which PBMCs were collected and evaluable samples were obtained.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: 40 mg QD', 'description': 'Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'FG001', 'title': 'Part 1: 80 mg QD', 'description': 'Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'FG002', 'title': 'Part 1: 160 mg QD', 'description': 'Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'FG003', 'title': 'Part 1 and Part 2: 160 mg BID', 'description': 'Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up were evaluated. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}, {'id': 'FG004', 'title': 'Part 1 and Part 2: 320 mg QD', 'description': 'Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up were evaluated. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}], 'periods': [{'title': 'Part 1: Dose Escalation', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Part 2: Expansion', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '274'}, {'groupId': 'FG004', 'numSubjects': '94'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '274'}, {'groupId': 'FG004', 'numSubjects': '94'}]}], 'dropWithdraws': [{'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '165'}, {'groupId': 'FG004', 'numSubjects': '67'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '74'}, {'groupId': 'FG004', 'numSubjects': '17'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '28'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted in 2 parts. The dose escalation part (Part 1) determined the recommended phase 2 dose (RP2D) and regimen and the dose expansion part (Part 2) further characterized the safety and efficacy at the RP2D.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '278', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}, {'value': '385', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: 40 mg QD', 'description': 'Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'BG001', 'title': 'Part 1: 80 mg QD', 'description': 'Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'BG002', 'title': 'Part 1: 160 mg QD', 'description': 'Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up'}, {'id': 'BG003', 'title': 'Part 1 and Part 2: 160 mg BID', 'description': 'Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up were evaluated. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}, {'id': 'BG004', 'title': 'Part 1 and Part 2: 320 mg QD', 'description': 'Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up were evaluated. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.7', 'spread': '9.45', 'groupId': 'BG000'}, {'value': '62.3', 'spread': '14.38', 'groupId': 'BG001'}, {'value': '72.6', 'spread': '8.88', 'groupId': 'BG002'}, {'value': '66.4', 'spread': '11.21', 'groupId': 'BG003'}, {'value': '65.8', 'spread': '11.24', 'groupId': 'BG004'}, {'value': '66.3', 'spread': '11.19', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '109', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '192', 'groupId': 'BG003'}, {'value': '75', 'groupId': 'BG004'}, {'value': '276', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}, {'value': '87', 'groupId': 'BG004'}, {'value': '303', 'groupId': 'BG005'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '53', 'groupId': 'BG005'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}]}, {'title': 'Native Hawaiians or other Pacific Islanders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Safety Analysis Set included all participants who received ≥ 1 dose of study drug'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-25', 'size': 1349537, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-03-30T15:57', 'hasProtocol': True}, {'date': '2018-10-19', 'size': 899544, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-03-30T15:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 385}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-26', 'studyFirstSubmitDate': '2015-01-09', 'resultsFirstSubmitDate': '2022-03-30', 'studyFirstSubmitQcDate': '2015-01-15', 'lastUpdatePostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-30', 'studyFirstPostDateStruct': {'date': '2015-01-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1 and Part 2: Number of Participants With Adverse Events', 'timeFrame': 'Up to approximately 6 years and 7 months', 'description': 'Number of participants with adverse events and serious adverse events, including clinically relevant physical examinations and laboratory measurements'}, {'measure': 'Part 1: Recommended Phase 2 Dose (RP2D) for Zanubrutinib', 'timeFrame': 'Month 9', 'description': 'RP2D for zanubrutinib was the maximum tolerated dose (MTD) or less, which was determined by testing increasing doses up to 320 mg QD'}], 'secondaryOutcomes': [{'measure': 'Part 1 and Part 2: Area Under the Curve From Time 0 to the Last Sampling Time Point Within the Dose Interval (AUClast) of Zanubrutinib', 'timeFrame': 'Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours'}, {'measure': 'Part 1 and Part 2: Area Under the Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Zanubrutinib', 'timeFrame': 'Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours'}, {'measure': 'Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) After Administration of Zanubrutinib', 'timeFrame': 'Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours'}, {'measure': 'Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) After Administration of Zanubrutinib', 'timeFrame': 'Week 2 Day 1 pre-dose and 24 hours'}, {'measure': 'Part 1 and Part 2: Time to Maximum Observed Plasma Concentration (Tmax) of Zanubrutinib', 'timeFrame': 'Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours'}, {'measure': 'Part 1 and Part 2: Time to Maximum Observed Plasma Concentration (Tmax) of Zanubrutinib', 'timeFrame': 'Week 2 Day 1 pre-dose and 24 hours'}, {'measure': 'Part 1 and Part 2: Apparent Terminal Half-life (t1/2) of Zanubrutinib', 'timeFrame': 'Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours'}, {'measure': 'Part 1 and Part 2: Apparent Clearance (CL/F) of Zanubrutinib', 'timeFrame': 'Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours'}, {'measure': 'Part 1 and Part 2: Apparent Volume of Distribution of Zanubrutinib During the Terminal Phase (Vz/F)', 'timeFrame': 'Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours'}, {'measure': 'Part 1 and Part 2: Overall Response Rate (ORR)', 'timeFrame': 'Up to 6 years and 7 months', 'description': "ORR is defined as the percentage of participants with partial or complete response (CR), as assessed by the investigator. For CLL/SLL, ORR includes partial response (PR) with lymphocytosis (PR-L) or better (includes PR-L, PR, nodular PR or nPR and CR with incomplete marrow recovery or CRi) and for MW, ORR includes minor response or better. Efficacy results are reported for each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL)."}, {'measure': 'Part 1 and Part 2: Complete Response Rate (CRR)', 'timeFrame': 'Up to 6 years and 7 months', 'description': "CRR is defined as the percentage of participants who achieve a complete response, as assessed by the investigator. For CLL/SLL, CRR includes CRi or better. For WM, CRR includes very good partial response (VGPR) or better. Efficacy results are reported for each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL)."}, {'measure': 'Part 1 and Part 2: Partial Response (PR) or Better', 'timeFrame': 'Up to 6 years and 7 months', 'description': 'PR or better is defined as the percentage of participants who achieve a partial response or better, as assessed by the investigator. For CLL/SLL, includes PR, nPR, CRi, CR and for WM includes PR, VGPR, and CR. Efficacy results are reported for the B-cell malignancy subtypes chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and Waldenström macroglobulinemia (WM).'}, {'measure': 'Part 1 and Part 2: Progression-free Survival (PFS)', 'timeFrame': 'Up to 6 years and 7 months', 'description': "PFS is defined as the time from the first dose date of study drug to the date of the earliest occurrence of progressive disease or death due to any cause, whichever occurs first. Efficacy results are reported for each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL)."}, {'measure': 'Part 1 and Part 2: Overall Survival (OS)', 'timeFrame': 'Up to 6 years and 7 months', 'description': "OS is defined as the time from the date of the first dose to death due to any cause. Efficacy results are reported for each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL)."}, {'measure': 'Part 1 and Part 2: Duration of Response (DOR)', 'timeFrame': 'Up to 6 years and 7 months', 'description': "DOR for responders is defined as time from the date of the earliest qualifying response to the date of progressive disease or death for any cause, whichever occurs earlier. Efficacy results are reported for responders (defined as PR or better, except CLL/SLL and WM) in each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL; PR with lymphocytosis or better), Waldenstrom macroglobulinemia (WM; minor response or better), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL)."}, {'measure': "Number of Participants With Greater Than 75% Bruton's Tyrosine Kinase (BTK) Occupancy", 'timeFrame': 'Week 1 Day 1 (W1D1) predose, W1D1 4 hours, W1D2 24 hours, W1D3 predose, and W2D1 predose', 'description': 'Number of participants with greater than 75% BTK occupancy of zanubrutinib in peripheral blood mononuclear cells (PBMCs)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['B-cell Malignancies']}, 'referencesModule': {'references': [{'pmid': '31340982', 'type': 'BACKGROUND', 'citation': 'Tam CS, Trotman J, Opat S, Burger JA, Cull G, Gottlieb D, Harrup R, Johnston PB, Marlton P, Munoz J, Seymour JF, Simpson D, Tedeschi A, Elstrom R, Yu Y, Tang Z, Han L, Huang J, Novotny W, Wang L, Roberts AW. Phase 1 study of the selective BTK inhibitor zanubrutinib in B-cell malignancies and safety and efficacy evaluation in CLL. Blood. 2019 Sep 12;134(11):851-859. doi: 10.1182/blood.2019001160. Epub 2019 Jul 24.'}, {'pmid': '32698195', 'type': 'BACKGROUND', 'citation': 'Trotman J, Opat S, Gottlieb D, Simpson D, Marlton P, Cull G, Munoz J, Tedeschi A, Roberts AW, Seymour JF, Atwal SK, Yu Y, Novotny W, Holmgren E, Tan Z, Hilger JD, Huang J, Tam CS. Zanubrutinib for the treatment of patients with Waldenstrom macroglobulinemia: 3 years of follow-up. Blood. 2020 Oct 29;136(18):2027-2037. doi: 10.1182/blood.2020006449.'}, {'type': 'BACKGROUND', 'citation': 'C.S. Tam M. Wang D. Simpson S. Opat G. Cull J. Munoz T.J. Phillips W. Kim S. Atwal R. Wei J. Huang R. Elstrom J. Trotman. UPDATED SAFETY AND EFFICACY DATA IN THE PHASE 1 TRIAL OF PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) TREATED WITH BRUTON TYROSINE KINASE (BTK) INHIBITOR ZANUBRUTINIB (BGB-3111). Hematological Oncology. 2019; 37(S2) DOI: https://doi.org/10.1002/hon.55_2630'}, {'pmid': '34915592', 'type': 'BACKGROUND', 'citation': 'Cull G, Burger JA, Opat S, Gottlieb D, Verner E, Trotman J, Marlton P, Munoz J, Johnston P, Simpson D, Stern JC, Prathikanti R, Wu K, Novotny W, Huang J, Tam CS. Zanubrutinib for treatment-naive and relapsed/refractory chronic lymphocytic leukaemia: long-term follow-up of the phase I/II AU-003 study. Br J Haematol. 2022 Mar;196(5):1209-1218. doi: 10.1111/bjh.17994. Epub 2021 Dec 16.'}, {'pmid': '39563886', 'type': 'DERIVED', 'citation': "Alfaifi A, Bahashwan S, Alsaadi M, Ageel AH, Ahmed HH, Fatima K, Malhan H, Qadri I, Almehdar H. Advancements in B-Cell Non-Hodgkin's Lymphoma: From Signaling Pathways to Targeted Therapies. Adv Hematol. 2024 Nov 12;2024:5948170. doi: 10.1155/2024/5948170. eCollection 2024."}, {'pmid': '38502198', 'type': 'DERIVED', 'citation': 'Moslehi JJ, Furman RR, Tam CS, Salem JE, Flowers CR, Cohen A, Zhang M, Zhang J, Chen L, Ma H, Brown JR. Cardiovascular events reported in patients with B-cell malignancies treated with zanubrutinib. Blood Adv. 2024 May 28;8(10):2478-2490. doi: 10.1182/bloodadvances.2023011641.'}, {'pmid': '35900694', 'type': 'DERIVED', 'citation': 'Xu W, Yang S, Tam CS, Seymour JF, Zhou K, Opat S, Qiu L, Sun M, Wang T, Trotman J, Pan L, Gao S, Zhou J, Zhou D, Zhu J, Song Y, Hu J, Feng R, Huang H, Su D, Shi M, Li J. Zanubrutinib Monotherapy for Naive and Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: A Pooled Analysis of Three Studies. Adv Ther. 2022 Sep;39(9):4250-4265. doi: 10.1007/s12325-022-02238-7. Epub 2022 Jul 28.'}, {'pmid': '35390135', 'type': 'DERIVED', 'citation': 'Phillips T, Chan H, Tam CS, Tedeschi A, Johnston P, Oh SY, Opat S, Eom HS, Allewelt H, Stern JC, Tan Z, Novotny W, Huang J, Trotman J. Zanubrutinib monotherapy in relapsed/refractory indolent non-Hodgkin lymphoma. Blood Adv. 2022 Jun 14;6(11):3472-3479. doi: 10.1182/bloodadvances.2021006083.'}, {'pmid': '34152395', 'type': 'DERIVED', 'citation': 'Tam CS, Opat S, Simpson D, Cull G, Munoz J, Phillips TJ, Kim WS, Rule S, Atwal SK, Wei R, Novotny W, Huang J, Wang M, Trotman J. Zanubrutinib for the treatment of relapsed or refractory mantle cell lymphoma. Blood Adv. 2021 Jun 22;5(12):2577-2585. doi: 10.1182/bloodadvances.2020004074.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluated the safety, tolerability, pharmacokinetic profile and efficacy of BGB-3111 in participants with B-cell lymphoid malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Aged ≥ 18 years, voluntarily consented to the study.\n2. WHO classification defined B-lymphoid malignancy, with the exception of Burkitt lymphoma/leukemia, plasma cell myeloma, acute lymphoblastic leukemia, lymphoblastic lymphoma, and plasmablastic lymphoma.\n3. Requirement for treatment in the opinion of the investigator.\n4. Disease which has relapsed, or is refractory, following at least one line of therapy, with no therapy of higher priority available.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n6. Adequate hematologic function, as defined by neutrophils ≥ 1.0 x 10\\^9/L and platelets ≥ 50 x 10\\^9/L; participants with neutrophils \\< 1.0 x 10\\^9/L due to marrow infiltration are allowed to receive growth factors to bring pre-treatment neutrophils to ≥ 1.0 x 10\\^9/L.\n7. Adequate renal function, as defined by creatinine clearance of ≥ 30 ml/min (as estimated by the Cockcroft-Gault equation or as measured by nuclear medicine scan or 24 hour urine collection).\n8. Adequate liver function, as defined by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN), and bilirubin ≤ 1.5 x ULN (unless documented Gilbert's syndrome).\n9. International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN.\n10. Female participants of childbearing potential and non-sterile males must practice at least one of the following methods of birth control with partner(s) throughout the study and for 90 days after discontinuing study drug: total abstinence from sexual intercourse, double-barrier contraception, IUD or hormonal contraceptive initiated at least 3 months prior to first dose of study drug.\n11. Male participants must not donate sperm from initial study drug administration, until 90 days after drug discontinuation.\n\nExclusion Criteria:\n\n1. Current central nervous system (CNS) involvement by disease\n2. Current histologically transformed disease.\n3. Prior Bruton's tyrosine kinase (BTK) inhibitor treatment.\n4. Allogeneic stem cell transplantation within 6 months, or has active graft-versus-host disease (GVHD) requiring ongoing immunosuppression.\n5. Receipt of the following treatment prior to first dose of zanubrutinib: corticosteroids given with anti-neoplastic intent within 7 days, chemotherapy or radiotherapy within 2 weeks, monoclonal antibody within 4 weeks.\n6. Not recovered from toxicity of any prior chemotherapy to grade ≤ 1.\n7. History of other active malignancies within 2 years of study entry, with exception of (1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or squamous cell carcinoma of skin; (3) previous malignancy confined and treated locally (surgery or other modality) with curative intent.\n8. Uncontrolled systemic infection requiring parenteral anti-microbial therapy.\n9. Major surgery in the past 4 weeks.\n10. Known HIV, or active hepatitis B or hepatitis C infection (detected positive by PCR).\n11. Cardiovascular disease resulting in New York Heart Association function status of ≥ 3.\n12. Significant active renal, neurologic, psychiatric, hepatic or endocrinologic disease that in the investigator's opinion would adversely impact on his/her participating in the study.\n13. Inability to comply with study procedures.\n14. On medications which are cytochrome P450 (CYP) 3A inhibitors."}, 'identificationModule': {'nctId': 'NCT02343120', 'briefTitle': 'Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'BeiGene'}, 'officialTitle': 'A Phase I/II, Open-Label, Multiple-Dose, Dose Escalation and Expansion Study to Investigate the Safety and Pharmacokinetics of the BTK Inhibitor BGB-3111 in Subjects With B-Cell Lymphoid Malignancies', 'orgStudyIdInfo': {'id': 'BGB-3111-AU-003'}, 'secondaryIdInfos': [{'id': '2016-003364-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zanubrutinib', 'description': 'Participants were administered up to 320 mg total daily dose of zanubrutinib until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up', 'interventionNames': ['Drug: Zanubrutinib']}], 'interventions': [{'name': 'Zanubrutinib', 'type': 'DRUG', 'otherNames': ['BGB-3111', 'Brukinsa'], 'description': 'Oral administration by capsule', 'armGroupLabels': ['Zanubrutinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner MD Anderson Cancer Centre', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55901', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M.D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Concord', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Concord Repatriation General Hospital', 'geoPoint': {'lat': -33.84722, 'lon': 151.10381}}, {'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'St George Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'city': 'Hobart', 'state': 'Tasmania', 'country': 'Australia', 'facility': 'Royal Hobart Hospital', 'geoPoint': {'lat': -42.87936, 'lon': 147.32941}}, {'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Health', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'city': 'Heidelberg', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Austin Health', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': "St Vincent's Hospital", 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3050', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre, East Melbourne', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Melbourne Health', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Sir Charles Gairdner Hospital', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'city': 'Bologna', 'country': 'Italy', 'facility': 'Policlinico S.Orsola Malpighi, AOU di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Milan', 'country': 'Italy', 'facility': "Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Auckland', 'country': 'New Zealand', 'facility': 'North Shore Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Dong-A University Medical Centre', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Goyang-si', 'country': 'South Korea', 'facility': 'National Cancer Center', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Plymouth', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'Derriford Hospital', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'BeiGene'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BeiGene', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}