Viewing Study NCT02457559

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Ignite Creation Date: 2025-12-24 @ 2:56 PM
Ignite Modification Date: 2026-04-22 @ 1:11 PM
Study NCT ID: NCT02457559
Status: COMPLETED
Last Update Posted: 2022-03-24
First Post: 2015-05-27
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Study to Assess the Long-term Safety and Efficacy of Tirabrutinib in Adults With Relapsed/Refractory B-cell Malignancies
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000608238', 'term': 'tirabrutinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GileadClinicalTrials@gilead.com', 'phone': '1-833-445-3230 (GILEAD-0)', 'title': 'Gilead Clinical Study Information Center', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-Cause Mortality: Enrollment up to 39 months in parent study and up to 61months in the rollover study Adverse Events (AE): First dose of tirabrutinib up to 36 months in the parent study and up to 61 months in the rollover study', 'description': 'All-Cause Mortality: All Enrolled Analysis Set:All participants enrolled in GS-US-401-1787.No participant in 40mg group.\n\nAE:Safety Analysis Set (SAS):All participants who took at least 1 dose of study drug in this study.For analyses based on SAS, participants were grouped according to actual treatment with longest exposure duration in parent and rollover study. 1 participant in 600mg arm (CLL), received 40mg dose for longer period of time in parent study and was included in 40mg group in SAS.', 'eventGroups': [{'id': 'EG000', 'title': 'Tirabrutinib 40 mg QD (CLL)', 'description': 'Participants with relapsed/refractory chronic lymphocytic leukemia (CLL) received tirabrutinib 40 mg once daily (QD) for up to 96 months from first dose in the parent study.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 0, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tirabrutinib 80 mg QD (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily for up to 96 months from first dose in the parent study.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Tirabrutinib 160 mg QD (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Tirabrutinib 320 mg QD (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'Tirabrutinib 400 mg QD (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily for up to 96 months from first dose in the parent study.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Tirabrutinib 500 mg QD (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily for up to 96 months from first dose in the parent study.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Tirabrutinib 600 mg QD (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'Tirabrutinib 300 mg BID (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily (BID) for up to 96 months from first dose in the parent study.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'Tirabrutinib 160 mg QD (NHL)', 'description': "Participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.", 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Tirabrutinib 320 mg QD (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG010', 'title': 'Tirabrutinib 480 mg QD (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily for up to 96 months from first dose in the parent study.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG011', 'title': 'Tirabrutinib 600 mg QD (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bone marrow oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lymphocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pernicious anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Spontaneous haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiac flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Deafness unilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ear pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 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0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 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and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Colorectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Scrotal swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirabrutinib 40 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 40 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG001', 'title': 'Tirabrutinib 80 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG002', 'title': 'Tirabrutinib 160 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG003', 'title': 'Tirabrutinib 320 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG004', 'title': 'Tirabrutinib 400 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG005', 'title': 'Tirabrutinib 500 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG006', 'title': 'Tirabrutinib 600 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG007', 'title': 'Tirabrutinib 300 mg Twice Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily (BID) for up to 96 months from first dose in the parent study.'}, {'id': 'OG008', 'title': 'Tirabrutinib 160 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG009', 'title': 'Tirabrutinib 320 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG010', 'title': 'Tirabrutinib 480 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG011', 'title': 'Tirabrutinib 600 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '100.0', 'groupId': 'OG005'}, {'value': '100.0', 'groupId': 'OG006'}, {'value': '100.0', 'groupId': 'OG007'}, {'value': '100.0', 'groupId': 'OG008'}, {'value': '100.0', 'groupId': 'OG009'}, {'value': '100.0', 'groupId': 'OG010'}, {'value': '100.0', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose of tirabrutinib up to 36 months in the parent study and up to 61 months in the rollover study', 'description': 'Treatment-emergent AEs were defined as one or both of the following:\n\n* Any AEs with an onset date on or after the study drug start date of parent study and no later than 30 days after permanent discontinuation of study drug in this rollover study;\n* Any AEs leading to premature discontinuation of study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who took at least 1 dose of study drug in the study. The data for this study are summarized by integrating the parent (NCT01659255) study data and rollover study data. One participant in 600 mg arm (CLL), received 40 mg dose for a longer period of time in parent study. Hence, this participant was included in 40 mg arm in safety analysis set.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced Treatment-Emergent Marked Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirabrutinib 40 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 40 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG001', 'title': 'Tirabrutinib 80 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG002', 'title': 'Tirabrutinib 160 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG003', 'title': 'Tirabrutinib 320 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG004', 'title': 'Tirabrutinib 400 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG005', 'title': 'Tirabrutinib 500 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG006', 'title': 'Tirabrutinib 600 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG007', 'title': 'Tirabrutinib 300 mg Twice Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG008', 'title': 'Tirabrutinib 160 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG009', 'title': 'Tirabrutinib 320 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG010', 'title': 'Tirabrutinib 480 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG011', 'title': 'Tirabrutinib 600 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}, {'value': '71.4', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '100.0', 'groupId': 'OG005'}, {'value': '100.0', 'groupId': 'OG006'}, {'value': '50.0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '33.3', 'groupId': 'OG009'}, {'value': '50.0', 'groupId': 'OG010'}, {'value': '50.0', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose of tirabrutinib up to 36 months in the parent study and up to 61 months in the rollover study', 'description': 'Treatment-emergent marked laboratory abnormalities were defined as values that increase from baseline by at least 3 toxicity grades at any postbaseline time point, up to and including the date of the last dose of study drug plus 30. If the relevant baseline laboratory value is missing, any Grade 3 or 4 values observed within the timeframe specified above will be considered treatment-emergent marked abnormalities. Laboratory assessments included tests for Chemistry, Hematology, Coagulation and Urinalysis.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set were analyzed. The data for this study are summarized by integrating the parent study (NCT01659255) data and rollover study data. One participant in 600 mg arm (CLL), received 40 mg dose for a longer period of time in parent study. Hence, this participant was included in 40 mg arm in safety analysis set.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirabrutinib 80 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG001', 'title': 'Tirabrutinib 160 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG002', 'title': 'Tirabrutinib 320 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG003', 'title': 'Tirabrutinib 400 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG004', 'title': 'Tirabrutinib 500 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG005', 'title': 'Tirabrutinib 600 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG006', 'title': 'Tirabrutinib 300 mg Twice Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG007', 'title': 'Tirabrutinib 160 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG008', 'title': 'Tirabrutinib 320 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG009', 'title': 'Tirabrutinib 480 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG010', 'title': 'Tirabrutinib 600 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '100'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '29.2', 'upperLimit': '100'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '59', 'upperLimit': '100'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '15.8', 'upperLimit': '100'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '100'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100'}, {'value': '100.0', 'groupId': 'OG006', 'lowerLimit': '15.8', 'upperLimit': '100'}, {'value': '100.0', 'groupId': 'OG007', 'lowerLimit': '2.5', 'upperLimit': '100'}, {'value': '100.0', 'groupId': 'OG008', 'lowerLimit': '29.2', 'upperLimit': '100'}, {'value': '100.0', 'groupId': 'OG009', 'lowerLimit': '39.8', 'upperLimit': '100'}, {'value': '50.0', 'groupId': 'OG010', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 39 months in parent study and up to 60 months in rollover study', 'description': 'ORR was defined per Modified International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria for CLL and Cheson, 2007 criteria for NHL as percentage of participants who achieve partial response (PR) or complete response (CR) in either parent or roll-over study. CLL:CR: lymphocytes (Ly) \\<4\\*10\\^9/L, no lymphadenopathy,normal spleen and liver size,absence of disease, absolute neutrophil count (ANC) \\>1.5\\*10\\^9/L,platelets ≥100\\*10\\^9/L, hemoglobin (Hb) \\>110 g/L,bone marrow at least normocellular for age; PR: ≥2 of these: ≥50% decrease in Ly, lymphadenopathy,size of liver and spleen, bone marrow infiltrates;and ≥1 of these: ANC \\>1500/μL, platelets ≥100,000/µL, Hb \\>11g/dL. NHL:CR: complete resolution of all disease-related radiological abnormalities; PR: ≥50% reduction in sum of products (SPD) of the longest diameters (LD) of all index lesions,no new lesions;no increase in size of liver or spleen;persistence of bone marrow involvement in participant who meets other criteria for CR.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set consisted of all enrolled participants who took at least 1 dose of study drug in the study. The data for this study are summarized by integrating the parent study (NCT01659255) data and rollover study data.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirabrutinib 80 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG001', 'title': 'Tirabrutinib 160 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG002', 'title': 'Tirabrutinib 320 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG003', 'title': 'Tirabrutinib 400 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG004', 'title': 'Tirabrutinib 500 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG005', 'title': 'Tirabrutinib 600 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG006', 'title': 'Tirabrutinib 300 mg Twice Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG007', 'title': 'Tirabrutinib 160 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG008', 'title': 'Tirabrutinib 320 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG009', 'title': 'Tirabrutinib 480 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG010', 'title': 'Tirabrutinib 600 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '61.7', 'upperLimit': 'NA'}, {'value': '27.0', 'groupId': 'OG001', 'lowerLimit': '26.3', 'upperLimit': '42.3'}, {'value': '57.7', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG002', 'lowerLimit': '39.8', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG003', 'lowerLimit': '76.6', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '33.6', 'groupId': 'OG005', 'lowerLimit': '25.7', 'upperLimit': '41.4'}, {'value': 'NA', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG006', 'lowerLimit': '33.6', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '63.2', 'groupId': 'OG008', 'lowerLimit': '23.9', 'upperLimit': '63.2'}, {'value': '71.4', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG009', 'lowerLimit': '53.6', 'upperLimit': 'NA'}, {'value': '37.0', 'groupId': 'OG010', 'lowerLimit': '37.0', 'upperLimit': '37.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first documentation of CR or PR to the first documentation of disease progression or death from any cause up to 39 months in parent study and up to 60 months in the rollover study', 'description': 'DOR was defined per IWCLL 2008 criteria for CLL and Cheson, 2007 criteria for NHL as the interval from first documentation of CR or PR to the earlier of the first documentation of definitive disease progression as assessed by the investigator, or death from any cause in subjects who achieve a response. CLL:CR: Ly \\<4\\*10\\^9/L, no lymphadenopathy, normal spleen and liver size, absence of disease, ANC \\>1.5\\*10\\^9/L, platelets ≥100\\*10\\^9/L, Hb \\>110 g/L, bone marrow at least normocellular for age; PR: ≥2 of these: ≥50% decrease in Ly, lymphadenopathy, size of liver and spleen, bone marrow infiltrates; and ≥1 of these: ANC \\>1500/μL, platelets ≥100,000/µL, Hb \\>11 g/dL. NHL:CR: complete resolution of all disease-related radiological abnormalities; PR: ≥50% reduction in SPD of the LD of all index lesions, no new lesions; no increase in size of liver or spleen; persistence of bone marrow involvement in participant who meets other criteria for CR.', 'unitOfMeasure': 'months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed. Participants who achieved a response are included in the analysis. The data for this study are summarized by integrating the parent study (NCT01659255) data and rollover study data.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirabrutinib 80 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG001', 'title': 'Tirabrutinib 160 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG002', 'title': 'Tirabrutinib 320 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG003', 'title': 'Tirabrutinib 400 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG004', 'title': 'Tirabrutinib 500 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG005', 'title': 'Tirabrutinib 600 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG006', 'title': 'Tirabrutinib 300 mg Twice Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG007', 'title': 'Tirabrutinib 160 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG008', 'title': 'Tirabrutinib 320 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG009', 'title': 'Tirabrutinib 480 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG010', 'title': 'Tirabrutinib 600 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '63.5', 'upperLimit': 'NA'}, {'value': '44.0', 'groupId': 'OG001', 'lowerLimit': '28.1', 'upperLimit': '44.1'}, {'value': '59.5', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG002', 'lowerLimit': '41.6', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG003', 'lowerLimit': '78.5', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '35.4', 'groupId': 'OG005', 'lowerLimit': '27.6', 'upperLimit': '43.3'}, {'value': 'NA', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG006', 'lowerLimit': '39.1', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '65.0', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG008', 'lowerLimit': '25.8', 'upperLimit': 'NA'}, {'value': '73.2', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG009', 'lowerLimit': '57.3', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG010', 'lowerLimit': '38.9', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of tirabrutinib in the parent study (NCT01659255) to the first documentation of disease progression or death from any cause up to 99 months', 'description': 'PFS was defined per IWCLL 2008 criteria for CLL and Cheson 2007 criteria for NHL as the interval from date of the first dose of tirabrutinib on the parent study to the earlier of the first documentation of definitive disease progression as assessed by the investigator, or death from any cause.\n\nProgressive disease (PD) in CLL: Lymphadenopathy, or appearance of any new lesion/organomegaly, \\> 50% increase in the size of the liver and/or spleen, Decrease in platelet count or hemoglobin attributable to CLL per IWCLL, Transformation to a more aggressive histology (eg, Richter syndrome).\n\nPD in NHL: Cheson, 2007: Appearance of new lesion or increase by \\>50% of previously involved sites from nadir, Transformation to a more aggressive NHL histology.', 'unitOfMeasure': 'months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed. The data for this study are summarized by integrating the parent study (NCT01659255) data and rollover study data.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Tirabrutinib 80 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG001', 'title': 'Tirabrutinib 160 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG002', 'title': 'Tirabrutinib 320 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG003', 'title': 'Tirabrutinib 400 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG004', 'title': 'Tirabrutinib 500 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG005', 'title': 'Tirabrutinib 600 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG006', 'title': 'Tirabrutinib 300 mg Twice Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG007', 'title': 'Tirabrutinib 160 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG008', 'title': 'Tirabrutinib 320 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG009', 'title': 'Tirabrutinib 480 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'OG010', 'title': 'Tirabrutinib 600 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '44.8', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG006', 'lowerLimit': '40.8', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG008', 'lowerLimit': '65.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG009', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not reached due to insufficient number of participants with events.', 'groupId': 'OG010', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of tirabrutinib in the parent study (NCT01659255) until death from any cause up to 99 months', 'description': 'OS is defined as the interval from date of the first dose of tirabrutinib on the parent study until death from any cause.', 'unitOfMeasure': 'months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed. The data for this study are summarized by integrating the parent (NCT01659255) study data and rollover study data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tirabrutinib 80 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory chronic lymphocytic leukemia (CLL) received tirabrutinib 80 mg once daily for up to 96 months from first dose in parent study.'}, {'id': 'FG001', 'title': 'Tirabrutinib 160 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'FG002', 'title': 'Tirabrutinib 320 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'FG003', 'title': 'Tirabrutinib 400 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'FG004', 'title': 'Tirabrutinib 500 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'FG005', 'title': 'Tirabrutinib 600 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'FG006', 'title': 'Tirabrutinib 300 mg Twice Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily for up to 96 months from first dose in the parent study.'}, {'id': 'FG007', 'title': 'Tirabrutinib 160 mg Once Daily (NHL)', 'description': "Participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study."}, {'id': 'FG008', 'title': 'Tirabrutinib 320 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'FG009', 'title': 'Tirabrutinib 480 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'FG010', 'title': 'Tirabrutinib 600 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '4'}, {'groupId': 'FG010', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '4'}, {'groupId': 'FG010', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}]}, {'type': "Investigator's Discretion", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in the United Kingdom and France. The first participant was screened on 10 September 2015. The last study visit occurred on 30 December 2020.', 'preAssignmentDetails': '102 participants were screened. Participants must have been enrolled in parent study ONO-4059POE001 (NCT01659255) to be eligible to receive continued access to tirabrutinib in this rollover study. The dosing regimen was based on the prior dosing regimen from the parent study. As pre-specified in the protocol, the data from both the parent and rollover studies were analyzed together for participants in this rollover study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '29', 'groupId': 'BG011'}]}], 'groups': [{'id': 'BG000', 'title': 'Tirabrutinib 80 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'BG001', 'title': 'Tirabrutinib 160 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'BG002', 'title': 'Tirabrutinib 320 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'BG003', 'title': 'Tirabrutinib 400 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'BG004', 'title': 'Tirabrutinib 500 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'BG005', 'title': 'Tirabrutinib 600 mg Once Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'BG006', 'title': 'Tirabrutinib 300 mg Twice Daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily for up to 96 months from first dose in the parent study.'}, {'id': 'BG007', 'title': 'Tirabrutinib 160 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study'}, {'id': 'BG008', 'title': 'Tirabrutinib 320 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'BG009', 'title': 'Tirabrutinib 480 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'BG010', 'title': 'Tirabrutinib 600 mg Once Daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.'}, {'id': 'BG011', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '11', 'groupId': 'BG011'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '18', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Age was calculated from the date of first study drug administration of the parent study NCT01659255.', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '23', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Gender was from the parent study NCT01659255.', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '25', 'groupId': 'BG011'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race was from the parent study NCT01659255.', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '29', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Ethnicity was from the parent study NCT01659255.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '20', 'groupId': 'BG011'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '9', 'groupId': 'BG011'}]}]}], 'paramType': 'NUMBER', 'description': 'All Enrolled Analysis Set included all participants enrolled into this study.', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Full Analysis Set included all enrolled participants who took at least 1 dose of study drug in the study. The data for this study are summarized by integrating the parent (NCT01659255) study data and rollover study data.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-29', 'size': 2502017, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-05T15:17', 'hasProtocol': True}, {'date': '2021-02-10', 'size': 1024907, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-10-05T15:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-23', 'studyFirstSubmitDate': '2015-05-27', 'resultsFirstSubmitDate': '2021-12-08', 'studyFirstSubmitQcDate': '2015-05-27', 'lastUpdatePostDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-23', 'studyFirstPostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs)', 'timeFrame': 'First dose of tirabrutinib up to 36 months in the parent study and up to 61 months in the rollover study', 'description': 'Treatment-emergent AEs were defined as one or both of the following:\n\n* Any AEs with an onset date on or after the study drug start date of parent study and no later than 30 days after permanent discontinuation of study drug in this rollover study;\n* Any AEs leading to premature discontinuation of study drug.'}, {'measure': 'Percentage of Participants Who Experienced Treatment-Emergent Marked Laboratory Abnormalities', 'timeFrame': 'First dose of tirabrutinib up to 36 months in the parent study and up to 61 months in the rollover study', 'description': 'Treatment-emergent marked laboratory abnormalities were defined as values that increase from baseline by at least 3 toxicity grades at any postbaseline time point, up to and including the date of the last dose of study drug plus 30. If the relevant baseline laboratory value is missing, any Grade 3 or 4 values observed within the timeframe specified above will be considered treatment-emergent marked abnormalities. Laboratory assessments included tests for Chemistry, Hematology, Coagulation and Urinalysis.'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Up to 39 months in parent study and up to 60 months in rollover study', 'description': 'ORR was defined per Modified International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria for CLL and Cheson, 2007 criteria for NHL as percentage of participants who achieve partial response (PR) or complete response (CR) in either parent or roll-over study. CLL:CR: lymphocytes (Ly) \\<4\\*10\\^9/L, no lymphadenopathy,normal spleen and liver size,absence of disease, absolute neutrophil count (ANC) \\>1.5\\*10\\^9/L,platelets ≥100\\*10\\^9/L, hemoglobin (Hb) \\>110 g/L,bone marrow at least normocellular for age; PR: ≥2 of these: ≥50% decrease in Ly, lymphadenopathy,size of liver and spleen, bone marrow infiltrates;and ≥1 of these: ANC \\>1500/μL, platelets ≥100,000/µL, Hb \\>11g/dL. NHL:CR: complete resolution of all disease-related radiological abnormalities; PR: ≥50% reduction in sum of products (SPD) of the longest diameters (LD) of all index lesions,no new lesions;no increase in size of liver or spleen;persistence of bone marrow involvement in participant who meets other criteria for CR.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'From first documentation of CR or PR to the first documentation of disease progression or death from any cause up to 39 months in parent study and up to 60 months in the rollover study', 'description': 'DOR was defined per IWCLL 2008 criteria for CLL and Cheson, 2007 criteria for NHL as the interval from first documentation of CR or PR to the earlier of the first documentation of definitive disease progression as assessed by the investigator, or death from any cause in subjects who achieve a response. CLL:CR: Ly \\<4\\*10\\^9/L, no lymphadenopathy, normal spleen and liver size, absence of disease, ANC \\>1.5\\*10\\^9/L, platelets ≥100\\*10\\^9/L, Hb \\>110 g/L, bone marrow at least normocellular for age; PR: ≥2 of these: ≥50% decrease in Ly, lymphadenopathy, size of liver and spleen, bone marrow infiltrates; and ≥1 of these: ANC \\>1500/μL, platelets ≥100,000/µL, Hb \\>11 g/dL. NHL:CR: complete resolution of all disease-related radiological abnormalities; PR: ≥50% reduction in SPD of the LD of all index lesions, no new lesions; no increase in size of liver or spleen; persistence of bone marrow involvement in participant who meets other criteria for CR.'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'From first dose of tirabrutinib in the parent study (NCT01659255) to the first documentation of disease progression or death from any cause up to 99 months', 'description': 'PFS was defined per IWCLL 2008 criteria for CLL and Cheson 2007 criteria for NHL as the interval from date of the first dose of tirabrutinib on the parent study to the earlier of the first documentation of definitive disease progression as assessed by the investigator, or death from any cause.\n\nProgressive disease (PD) in CLL: Lymphadenopathy, or appearance of any new lesion/organomegaly, \\> 50% increase in the size of the liver and/or spleen, Decrease in platelet count or hemoglobin attributable to CLL per IWCLL, Transformation to a more aggressive histology (eg, Richter syndrome).\n\nPD in NHL: Cheson, 2007: Appearance of new lesion or increase by \\>50% of previously involved sites from nadir, Transformation to a more aggressive NHL histology.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From first dose of tirabrutinib in the parent study (NCT01659255) until death from any cause up to 99 months', 'description': 'OS is defined as the interval from date of the first dose of tirabrutinib on the parent study until death from any cause.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed/Refractory B-cell Malignancies']}, 'referencesModule': {'references': [{'pmid': '30011241', 'type': 'BACKGROUND', 'citation': 'Yu H, Truong H, Mitchell SA, Liclican A, Gosink JJ, Li W, Lin J, Feng JY, Jurgensmeier JM, Billin A, Xu R, Patterson S, Pagratis N. Homogeneous BTK Occupancy Assay for Pharmacodynamic Assessment of Tirabrutinib (GS-4059/ONO-4059) Target Engagement. SLAS Discov. 2018 Oct;23(9):919-929. doi: 10.1177/2472555218786165. Epub 2018 Jul 16.'}, {'pmid': '31827243', 'type': 'RESULT', 'citation': "Rule SA, Cartron G, Fegan C, Morschhauser F, Han L, Mitra S, Salles G, Dyer MJS. Long-term follow-up of patients with mantle cell lymphoma (MCL) treated with the selective Bruton's tyrosine kinase inhibitor tirabrutinib (GS/ONO-4059). Leukemia. 2020 May;34(5):1458-1461. doi: 10.1038/s41375-019-0658-7. Epub 2019 Dec 11. No abstract available."}, {'pmid': '28377400', 'type': 'RESULT', 'citation': "Walter HS, Jayne S, Rule SA, Cartron G, Morschhauser F, Macip S, Karlin L, Jones C, Herbaux C, Quittet P, Shah N, Hutchinson CV, Fegan C, Yang Y, Mitra S, Salles G, Dyer MJS. Long-term follow-up of patients with CLL treated with the selective Bruton's tyrosine kinase inhibitor ONO/GS-4059. Blood. 2017 May 18;129(20):2808-2810. doi: 10.1182/blood-2017-02-765115. Epub 2017 Apr 4. No abstract available."}, {'pmid': '26542378', 'type': 'RESULT', 'citation': 'Walter HS, Rule SA, Dyer MJ, Karlin L, Jones C, Cazin B, Quittet P, Shah N, Hutchinson CV, Honda H, Duffy K, Birkett J, Jamieson V, Courtenay-Luck N, Yoshizawa T, Sharpe J, Ohno T, Abe S, Nishimura A, Cartron G, Morschhauser F, Fegan C, Salles G. A phase 1 clinical trial of the selective BTK inhibitor ONO/GS-4059 in relapsed and refractory mature B-cell malignancies. Blood. 2016 Jan 28;127(4):411-9. doi: 10.1182/blood-2015-08-664086. Epub 2015 Nov 5.'}, {'pmid': '27248633', 'type': 'RESULT', 'citation': 'Walter HS, Salles GA, Dyer MJ. New Agents to Treat Chronic Lymphocytic Leukemia. N Engl J Med. 2016 Jun 2;374(22):2185-6. doi: 10.1056/NEJMc1602674. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the long-term safety and tolerability of tirabrutinib in adults with relapsed/refractory B-cell malignancy who have tolerated and achieved stable disease or improved with tirabrutinib treatment while enrolled in a prior (parent study) tirabrutinib study (NCT01659255). The dosing regimen will be based on the prior dosing regimen from the parent study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Currently enrolled in a prior tirabrutinib study\n* Did not discontinue treatment with tirabrutinib for any reason other than to enroll in this study\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at enrollment in this study\n* Any Grade 3 or 4 non-hematologic toxicity that the investigator considers related to previous tirabrutinib use must have resolved, reverted to Grade 1, or reverted to the baseline of the prior study prior to Day 1 of this study\n* Negative serum and urine pregnancy test is required for female individuals (unless surgically sterile or greater than 2 years post menopausal)\n* Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the protocol\n* Lactating females must agree to discontinue nursing before the study drug is administered\n* Ability and agreement to attend protocol-specified visits at the study site\n* Able to comprehend and willing to sign the informed consent form\n\nKey Exclusion Criteria:\n\n* Known hypersensitivity to tirabrutinib, its metabolites, or formulation excipients\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02457559', 'briefTitle': 'Study to Assess the Long-term Safety and Efficacy of Tirabrutinib in Adults With Relapsed/Refractory B-cell Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'An Open-label Study to Assess the Long-term Safety and Efficacy of ONO/GS-4059 in Subjects With Relapsed/Refractory B-cell Malignancies', 'orgStudyIdInfo': {'id': 'GS-US-401-1787'}, 'secondaryIdInfos': [{'id': '2015-001404-58', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tirabrutinib 40 mg once daily (CLL)', 'description': 'Participants with relapsed/refractory chronic lymphocytic leukemia (CLL) received tirabrutinib 40 mg once daily for up to 96 months from first dose in the parent study.', 'interventionNames': ['Drug: Tirabrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Tirabrutinib 80 mg once daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily for up to 96 months from first dose in the parent study.', 'interventionNames': ['Drug: Tirabrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Tirabrutinib 160 mg once daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.', 'interventionNames': ['Drug: Tirabrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Tirabrutinib 320 mg once daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.', 'interventionNames': ['Drug: Tirabrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Tirabrutinib 400 mg once daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily for up to 96 months from first dose in the parent study.', 'interventionNames': ['Drug: Tirabrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Tirabrutinib 500 mg once daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily for up to 96 months from first dose in the parent study.', 'interventionNames': ['Drug: Tirabrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Tirabrutinib 600 mg once daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.', 'interventionNames': ['Drug: Tirabrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Tirabrutinib 300 mg twice daily (CLL)', 'description': 'Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily for up to 96 months from first dose in the parent study.', 'interventionNames': ['Drug: Tirabrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Tirabrutinib 160 mg once daily (NHL)', 'description': "Participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.", 'interventionNames': ['Drug: Tirabrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Tirabrutinib 320 mg once daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.', 'interventionNames': ['Drug: Tirabrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Tirabrutinib 480 mg once daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily for up to 96 months from first dose in the parent study.', 'interventionNames': ['Drug: Tirabrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Tirabrutinib 600 mg once daily (NHL)', 'description': 'Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.', 'interventionNames': ['Drug: Tirabrutinib']}], 'interventions': [{'name': 'Tirabrutinib', 'type': 'DRUG', 'otherNames': ['ONO/GS-4059'], 'description': 'Tablets or capsules administered orally', 'armGroupLabels': ['Tirabrutinib 160 mg once daily (CLL)', 'Tirabrutinib 160 mg once daily (NHL)', 'Tirabrutinib 300 mg twice daily (CLL)', 'Tirabrutinib 320 mg once daily (CLL)', 'Tirabrutinib 320 mg once daily (NHL)', 'Tirabrutinib 40 mg once daily (CLL)', 'Tirabrutinib 400 mg once daily (CLL)', 'Tirabrutinib 480 mg once daily (NHL)', 'Tirabrutinib 500 mg once daily (CLL)', 'Tirabrutinib 600 mg once daily (CLL)', 'Tirabrutinib 600 mg once daily (NHL)', 'Tirabrutinib 80 mg once daily (CLL)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'state': 'Nord', 'country': 'France', 'facility': 'CHRU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hopital Saint Eloi', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '69310', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': 'CF14 4XW', 'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'University Hospital of Wales', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'LE1 5WW', 'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Leicester Royal Infirmary', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'PL68DH', 'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Derriford Hospital', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}