Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-03-11 @ 11:02 AM
Study NCT ID:
NCT01607892
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2012-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced Hematological Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D008258', 'term': 'Waldenstrom Macroglobulinemia'}, {'id': 'D016411', 'term': 'Lymphoma, T-Cell, Peripheral'}, {'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C585161', 'term': 'selinexor'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jshah@karyopharm.com', 'phone': '(617) 658-0600', 'title': 'Jatin Shah, MD', 'organization': 'Karyopharm Therapeutics Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug administration to end of treatment (up to 27 months)', 'eventGroups': [{'id': 'EG000', 'title': 'Diffuse Large B-cell Lymphoma (DLBCL)', 'description': 'Participants with DLBCL received Selinexor in different Schedules; Schedule 1: \\<= 12 milligram per square meter (mg/m\\^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \\> 12 mg/m\\^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.', 'otherNumAtRisk': 58, 'otherNumAffected': 58, 'seriousNumAtRisk': 58, 'seriousNumAffected': 33}, {'id': 'EG001', 'title': 'Non-Hodgkin Lymphoma (NHL) Excluding DLBCL', 'description': 'Participants with NHL received Selinexor in different Schedules; Schedule 1: \\<= 12 mg/m\\^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \\> 12 mg/m\\^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly \\[1 Day between doses\\] during weeks 1 and 2; Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.', 'otherNumAtRisk': 27, 'otherNumAffected': 27, 'seriousNumAtRisk': 27, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Multiple Myeloma (MM)', 'description': 'Participants with MM received Selinexor in different Schedules; Schedule 1: \\<= 12 mg/m\\^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m\\^2 total) in the 1-week run-in period; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: \\>= 35 mg/m\\^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.', 'otherNumAtRisk': 81, 'otherNumAffected': 80, 'seriousNumAtRisk': 81, 'seriousNumAffected': 52}, {'id': 'EG003', 'title': 'Acute Myeloid Leukemia (AML)', 'description': 'Participants with AML received Selinexor in different Schedules; Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: \\>= 55 mg/m\\^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.', 'otherNumAtRisk': 95, 'otherNumAffected': 94, 'seriousNumAtRisk': 95, 'seriousNumAffected': 73}, {'id': 'EG004', 'title': 'Other Hematological Malignancies (ALL, CML and CLL)', 'description': 'Participants with other hematological malignancies (Acute lymphoblastic leukemia \\[ALL\\], Chronic myelogenous leukemia \\[CML\\] and chronic lymphocytic leukemia \\[CLL\\]) received Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly \\[1 day between doses\\]; Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.', 'otherNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 62}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 67}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 31}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 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(17.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '95', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Diffuse Large B-cell Lymphoma (DLBCL)', 'description': 'Participants with DLBCL received Selinexor in different Schedules; Schedule 1: \\<= 12 milligram per square meter (mg/m\\^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \\> 12 mg/m\\^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.'}, {'id': 'OG001', 'title': 'Non-Hodgkin Lymphoma (NHL) Excluding DLBCL', 'description': 'Participants with NHL received Selinexor in different Schedules; Schedule 1: \\<= 12 mg/m\\^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \\> 12 mg/m\\^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly \\[1 Day between doses\\] during weeks 1 and 2; Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.'}, {'id': 'OG002', 'title': 'Multiple Myeloma (MM)', 'description': 'Participants with MM received Selinexor in different Schedules; Schedule 1: \\<= 12 mg/m\\^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m\\^2 total) in the 1-week run-in period; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: \\>= 35 mg/m\\^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.'}, {'id': 'OG003', 'title': 'Acute Myeloid Leukemia (AML)', 'description': 'Participants with AML received Selinexor in different Schedules; Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: \\>= 55 mg/m\\^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.'}, {'id': 'OG004', 'title': 'Other Hematological Malignancies (ALL, CML and CLL)', 'description': 'Participants with other hematological malignancies (Acute lymphoblastic leukemia \\[ALL\\], Chronic myelogenous leukemia \\[CML\\] and chronic lymphocytic leukemia \\[CLL\\]) received Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly \\[1 day between doses\\]; Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.'}], 'classes': [{'title': 'At Least One TEAE', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '95', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}]}, {'title': 'At Least One Serious TEAE', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug administration to end of treatment (up to 27 months)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product during the course of a study and which does not necessarily have to have a causal relationship with this treatment. An Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death; life-threatening event; required or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. TEAEs are any untoward medical incidence in a participant during administered study treatment, whether or not these events were related to study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all participants who received at least 1 dose of selinexor.'}, {'type': 'PRIMARY', 'title': 'Recommended Phase 2 Dose (RP2D) of Selinexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced Hematological Malignancies.', 'description': 'Participants received selinexor doses of \\<= 12 mg/m\\^2, post oral for all cycles 3 times weekly for Weeks 1 and 3 in schedule 1; \\>12 mg/m\\^2 3 times weekly for Weeks 2 and 4 in schedule 2; \\>=30 mg/m\\^2 on Day 1 and 3 in schedule 3; \\>= 23 mg/m\\^2 on Day 1 and Day 2 for a 28-day cycle in schedule 4; \\>= 30 mg/m\\^2 on Day 1 and 4 in schedule 5; \\>= 35 mg/m\\^2 combined with dexamethasone 20 mg on Day 1 and 3 in schedule 6; \\>= 45 mg/m\\^2 once-weekly in schedule 7; \\>= 40 mg/m\\^2 twice-weekly for first 2 weeks on Days 1, 3, 8, and 10 followed by an 11-day treatment-free interval in schedule 8; \\>= 30 mg/m\\^2 twice weekly for 3 weeks in 28-day cycle followed by fixed dose of 375 mg/m\\^2 Rituximab in schedule 9; 55 mg/m\\^2 twice-weekly on Days 1, 3, 8, and 10 followed by 18-day treatment-free interval in schedule 10; 40, 60, 80 mg (group A, group B, group C) twice weekly during the first 3 weeks, on Days 1, 3, 8, 10, 15 and 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug administration to end of treatment (up to 27 months)', 'description': 'Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD was defined as the next lower dose level below the one in which \\> 1 of 3 participants or ≥ 2 of 6 participants experienced dose-limiting toxicity (DLT), provided that that dose level is ≤25% lower than the highest dose tested. If the projected MTD was \\>25% lower than the highest dose tested, then an additional cohort of ≥3 participants were added at a dose that was intermediate between the intolerable dose and the next lower dose.', 'unitOfMeasure': 'milligram per square meter (mg/m^2)', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set included all participants who had either completed 1 cycle of treatment or discontinued treatment prior to completing the first cycle due to documented progressive disease (PD), death related to disease, or treatment-related toxicity. Here, data was not planned and analyzed based on individual specific disease, hence overall data was analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Selinexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '8', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Selinexor (3 mg/m^2)', 'description': 'Participants received selinexor dose of 3 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG001', 'title': 'Selinexor (6 mg/m^2)', 'description': 'Participants received selinexor dose of 6 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG002', 'title': 'Selinexor (12 mg/m^2)', 'description': 'Participants received selinexor dose of 12 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG003', 'title': 'Selinexor (16.8 mg/m^2)', 'description': 'Participants received selinexor dose of 16.8 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 15, 17, 19, and 22 in schedule 2.'}, {'id': 'OG004', 'title': 'Selinexor (23 mg/m^2)', 'description': 'Participants received selinexor dose of 23 mg/m\\^2 orally at Cycle 1, on Day 1 and 2 of each week for a 28-day cycle in schedule 4.'}, {'id': 'OG005', 'title': 'Selinexor (30 mg/m^2)', 'description': 'Participants received selinexor dose of 30 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 4, 8, 10, 15 and 17 in schedule 3, 5 and 9.'}, {'id': 'OG006', 'title': 'Selinexor (35 mg/m^2)', 'description': 'Participants received selinexor dose of 35 mg/m\\^2 orally at Cycle 1, on Day 1 and 3 in schedule 6.'}, {'id': 'OG007', 'title': 'Selinexor (40 mg/m^2)', 'description': 'Participants received selinexor dose of 40 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 8 and 11.'}, {'id': 'OG008', 'title': 'Selinexor (46 mg/m^2)', 'description': 'Participants received selinexor dose of 46 mg/m\\^2 orally at Cycle 1, on Day 1 once-weekly in schedule 7.'}, {'id': 'OG009', 'title': 'Selinexor (55 mg/m^2)', 'description': 'Participants received selinexor dose of 55 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, and 10, followed by an 18-day treatment-free interval (Days 11 through 28) in schedule 10.'}, {'id': 'OG010', 'title': 'Selinexor (60 mg/m^2)', 'description': 'Participants received selinexor dose of 60 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}, {'id': 'OG011', 'title': 'Selinexor (70 mg/m^2)', 'description': 'Participants received selinexor dose of 70 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}, {'id': 'OG012', 'title': 'Selinexor (80 mg/m^2)', 'description': 'Participants received selinexor dose of 80 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.0', 'spread': 'NA', 'comment': 'Geometric coefficient of variation (CV) was not calculated as data were available for only two participants.', 'groupId': 'OG000'}, {'value': '50.0', 'spread': '61.1', 'groupId': 'OG001'}, {'value': '149', 'spread': '37.6', 'groupId': 'OG002'}, {'value': '205', 'spread': '46.8', 'groupId': 'OG003'}, {'value': '262', 'spread': '37.5', 'groupId': 'OG004'}, {'value': '387', 'spread': '37.1', 'groupId': 'OG005'}, {'value': '407', 'spread': '44.4', 'groupId': 'OG006'}, {'value': '416', 'spread': '36.6', 'groupId': 'OG007'}, {'value': '670', 'spread': '18.5', 'groupId': 'OG008'}, {'value': '583', 'spread': '41.4', 'groupId': 'OG009'}, {'value': '668', 'spread': '33.2', 'groupId': 'OG010'}, {'value': '800', 'spread': '32.4', 'groupId': 'OG011'}, {'value': '1068', 'spread': '49.3', 'groupId': 'OG012'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2', 'description': 'Cmax was defined as the maximum observed concentration, taken directly from the plasma concentration.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacokinetic (PK) analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for cycle 1 day1 (C1D1) could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Time to Maximum Observed Concentration (Tmax) of Selinexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '8', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Selinexor (3 mg/m^2)', 'description': 'Participants received selinexor dose of 3 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG001', 'title': 'Selinexor (6 mg/m^2)', 'description': 'Participants received selinexor dose of 6 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG002', 'title': 'Selinexor (12 mg/m^2)', 'description': 'Participants received selinexor dose of 12 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG003', 'title': 'Selinexor (16.8 mg/m^2)', 'description': 'Participants received selinexor dose of 16.8 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 15, 17, 19, and 22 in schedule 2.'}, {'id': 'OG004', 'title': 'Selinexor (23 mg/m^2)', 'description': 'Participants received selinexor dose of 23 mg/m\\^2 orally at Cycle 1, on Day 1 and 2 of each week for a 28-day cycle in schedule 4.'}, {'id': 'OG005', 'title': 'Selinexor (30 mg/m^2)', 'description': 'Participants received selinexor dose of 30 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 4, 8, 10, 15 and 17 in schedule 3, 5 and 9.'}, {'id': 'OG006', 'title': 'Selinexor (35 mg/m^2)', 'description': 'Participants received selinexor dose of 35 mg/m\\^2 orally at Cycle 1, on Day 1 and 3 in schedule 6.'}, {'id': 'OG007', 'title': 'Selinexor (40 mg/m^2)', 'description': 'Participants received selinexor dose of 40 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 8 and 11.'}, {'id': 'OG008', 'title': 'Selinexor (46 mg/m^2)', 'description': 'Participants received selinexor dose of 46 mg/m\\^2 orally at Cycle 1, on Day 1 once-weekly in schedule 7.'}, {'id': 'OG009', 'title': 'Selinexor (55 mg/m^2)', 'description': 'Participants received selinexor dose of 55 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, and 10, followed by an 18-day treatment-free interval (Days 11 through 28) in schedule 10.'}, {'id': 'OG010', 'title': 'Selinexor (60 mg/m^2)', 'description': 'Participants received selinexor dose of 60 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}, {'id': 'OG011', 'title': 'Selinexor (70 mg/m^2)', 'description': 'Participants received selinexor dose of 70 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}, {'id': 'OG012', 'title': 'Selinexor (80 mg/m^2)', 'description': 'Participants received selinexor dose of 80 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median value was not calculated due to insufficient PK samples required for calculation.', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '2.2'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '7.7'}, {'value': '3.0', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': '4.2'}, {'value': '2.08', 'groupId': 'OG003', 'lowerLimit': '0.92', 'upperLimit': '8.5'}, {'value': '2.0', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '7.8'}, {'value': '2.0', 'groupId': 'OG005', 'lowerLimit': '0.72', 'upperLimit': '4.4'}, {'value': '2.0', 'groupId': 'OG006', 'lowerLimit': '0.92', 'upperLimit': '4.1'}, {'value': '4.0', 'groupId': 'OG007', 'lowerLimit': '2.0', 'upperLimit': '7.5'}, {'value': '2.0', 'groupId': 'OG008', 'lowerLimit': '0.50', 'upperLimit': '4.2'}, {'value': '2.9', 'groupId': 'OG009', 'lowerLimit': '1.0', 'upperLimit': '8.0'}, {'value': '1.9', 'groupId': 'OG010', 'lowerLimit': '1.8', 'upperLimit': '2.0'}, {'value': '2.0', 'groupId': 'OG011', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG012', 'lowerLimit': '0.5', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2', 'description': 'Tmax was defined as time of first observation of Cmax, taken directly from the plasma concentration data.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for C1D1 could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Average Concentration From Time 0 to 24 Hours (Cavg0-24h) of Selinexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Selinexor (3 mg/m^2)', 'description': 'Participants received selinexor dose of 3 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG001', 'title': 'Selinexor (6 mg/m^2)', 'description': 'Participants received selinexor dose of 6 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG002', 'title': 'Selinexor (12 mg/m^2)', 'description': 'Participants received selinexor dose of 12 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG003', 'title': 'Selinexor (16.8 mg/m^2)', 'description': 'Participants received selinexor dose of 16.8 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 15, 17, 19, and 22 in schedule 2.'}, {'id': 'OG004', 'title': 'Selinexor (23 mg/m^2)', 'description': 'Participants received selinexor dose of 23 mg/m\\^2 orally at Cycle 1, on Day 1 and 2 of each week for a 28-day cycle in schedule 4.'}, {'id': 'OG005', 'title': 'Selinexor (30 mg/m^2)', 'description': 'Participants received selinexor dose of 30 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 4, 8, 10, 15 and 17 in schedule 3, 5 and 9.'}, {'id': 'OG006', 'title': 'Selinexor (35 mg/m^2)', 'description': 'Participants received selinexor dose of 35 mg/m\\^2 orally at Cycle 1, on Day 1 and 3 in schedule 6.'}, {'id': 'OG007', 'title': 'Selinexor (40 mg/m^2)', 'description': 'Participants received selinexor dose of 40 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 8 and 11.'}, {'id': 'OG008', 'title': 'Selinexor (46 mg/m^2)', 'description': 'Participants received selinexor dose of 46 mg/m\\^2 orally at Cycle 1, on Day 1 once-weekly in schedule 7.'}, {'id': 'OG009', 'title': 'Selinexor (55 mg/m^2)', 'description': 'Participants received selinexor dose of 55 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, and 10, followed by an 18-day treatment-free interval (Days 11 through 28) in schedule 10.'}, {'id': 'OG010', 'title': 'Selinexor (60 mg/m^2)', 'description': 'Participants received selinexor dose of 60 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}, {'id': 'OG011', 'title': 'Selinexor (70 mg/m^2)', 'description': 'Participants received selinexor dose of 70 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}, {'id': 'OG012', 'title': 'Selinexor (80 mg/m^2)', 'description': 'Participants received selinexor dose of 80 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.0', 'spread': 'NA', 'comment': 'Geometric CV was not calculated as data were available for only two participants.', 'groupId': 'OG000'}, {'value': '20.3', 'spread': '94.8', 'groupId': 'OG001'}, {'value': '61.8', 'spread': '39.9', 'groupId': 'OG002'}, {'value': '79.0', 'spread': '61.8', 'groupId': 'OG003'}, {'value': '108', 'spread': '46.8', 'groupId': 'OG004'}, {'value': '160', 'spread': '38.0', 'groupId': 'OG005'}, {'value': '168', 'spread': '54.0', 'groupId': 'OG006'}, {'value': '163', 'spread': '29.2', 'groupId': 'OG007'}, {'value': '297', 'spread': '26.3', 'groupId': 'OG008'}, {'value': '208', 'spread': '19.1', 'groupId': 'OG009'}, {'value': '337', 'spread': '4.2', 'groupId': 'OG010'}, {'value': '353', 'spread': '26.2', 'groupId': 'OG011'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and CV were not calculated as data were available for only one participant.', 'groupId': 'OG012'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2', 'description': 'Cavg0-24h was defined as average concentration from time 0 to 24 hours.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for C1D1 could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-Time Curve From Time 0 to t (AUC0-t) of Selinexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '8', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Selinexor (3 mg/m^2)', 'description': 'Participants received selinexor dose of 3 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG001', 'title': 'Selinexor (6 mg/m^2)', 'description': 'Participants received selinexor dose of 6 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG002', 'title': 'Selinexor (12 mg/m^2)', 'description': 'Participants received selinexor dose of 12 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG003', 'title': 'Selinexor (16.8 mg/m^2)', 'description': 'Participants received selinexor dose of 16.8 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 15, 17, 19, and 22 in schedule 2.'}, {'id': 'OG004', 'title': 'Selinexor (23 mg/m^2)', 'description': 'Participants received selinexor dose of 23 mg/m\\^2 orally at Cycle 1, on Day 1 and 2 of each week for a 28-day cycle in schedule 4.'}, {'id': 'OG005', 'title': 'Selinexor (30 mg/m^2)', 'description': 'Participants received selinexor dose of 30 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 4, 8, 10, 15 and 17 in schedule 3, 5 and 9.'}, {'id': 'OG006', 'title': 'Selinexor (35 mg/m^2)', 'description': 'Participants received selinexor dose of 35 mg/m\\^2 orally at Cycle 1, on Day 1 and 3 in schedule 6.'}, {'id': 'OG007', 'title': 'Selinexor (40 mg/m^2)', 'description': 'Participants received selinexor dose of 40 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 8 and 11.'}, {'id': 'OG008', 'title': 'Selinexor (46 mg/m^2)', 'description': 'Participants received selinexor dose of 46 mg/m\\^2 orally at Cycle 1, on Day 1 once-weekly in schedule 7.'}, {'id': 'OG009', 'title': 'Selinexor (55 mg/m^2)', 'description': 'Participants received selinexor dose of 55 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, and 10, followed by an 18-day treatment-free interval (Days 11 through 28) in schedule 10.'}, {'id': 'OG010', 'title': 'Selinexor (60 mg/m^2)', 'description': 'Participants received selinexor dose of 60 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}, {'id': 'OG011', 'title': 'Selinexor (70 mg/m^2)', 'description': 'Participants received selinexor dose of 70 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}, {'id': 'OG012', 'title': 'Selinexor (80 mg/m^2)', 'description': 'Participants received selinexor dose of 80 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}], 'classes': [{'categories': [{'measurements': [{'value': '331', 'spread': 'NA', 'comment': 'Geometric CV was not calculated as data were available for only two participants.', 'groupId': 'OG000'}, {'value': '564', 'spread': '41.9', 'groupId': 'OG001'}, {'value': '1459', 'spread': '20.5', 'groupId': 'OG002'}, {'value': '1829', 'spread': '23.3', 'groupId': 'OG003'}, {'value': '2774', 'spread': '36.7', 'groupId': 'OG004'}, {'value': '3461', 'spread': '26.9', 'groupId': 'OG005'}, {'value': '3901', 'spread': '29.2', 'groupId': 'OG006'}, {'value': '4481', 'spread': '23.8', 'groupId': 'OG007'}, {'value': '5228', 'spread': '21.6', 'groupId': 'OG008'}, {'value': '5601', 'spread': '36.2', 'groupId': 'OG009'}, {'value': '5282', 'spread': '57.9', 'groupId': 'OG010'}, {'value': '5466', 'spread': '45.7', 'groupId': 'OG011'}, {'value': '5544', 'spread': '33.2', 'groupId': 'OG012'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2', 'description': 'AUC0-t was defined as area under the concentration-time curve from time zero to the last non-zero concentration.', 'unitOfMeasure': 'nanogram* hours per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for C1D1 could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selinexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Selinexor (3 mg/m^2)', 'description': 'Participants received selinexor dose of 3 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG001', 'title': 'Selinexor (6 mg/m^2)', 'description': 'Participants received selinexor dose of 6 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG002', 'title': 'Selinexor (12 mg/m^2)', 'description': 'Participants received selinexor dose of 12 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG003', 'title': 'Selinexor (16.8 mg/m^2)', 'description': 'Participants received selinexor dose of 16.8 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 15, 17, 19, and 22 in schedule 2.'}, {'id': 'OG004', 'title': 'Selinexor (23 mg/m^2)', 'description': 'Participants received selinexor dose of 23 mg/m\\^2 orally at Cycle 1, on Day 1 and 2 of each week for a 28-day cycle in schedule 4.'}, {'id': 'OG005', 'title': 'Selinexor (30 mg/m^2)', 'description': 'Participants received selinexor dose of 30 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 4, 8, 10, 15 and 17 in schedule 3, 5 and 9.'}, {'id': 'OG006', 'title': 'Selinexor (35 mg/m^2)', 'description': 'Participants received selinexor dose of 35 mg/m\\^2 orally at Cycle 1, on Day 1 and 3 in schedule 6.'}, {'id': 'OG007', 'title': 'Selinexor (40 mg/m^2)', 'description': 'Participants received selinexor dose of 40 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 8 and 11.'}, {'id': 'OG008', 'title': 'Selinexor (46 mg/m^2)', 'description': 'Participants received selinexor dose of 46 mg/m\\^2 orally at Cycle 1, on Day 1 once-weekly in schedule 7.'}, {'id': 'OG009', 'title': 'Selinexor (55 mg/m^2)', 'description': 'Participants received selinexor dose of 55 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, and 10, followed by an 18-day treatment-free interval (Days 11 through 28) in schedule 10.'}, {'id': 'OG010', 'title': 'Selinexor (60 mg/m^2)', 'description': 'Participants received selinexor dose of 60 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}, {'id': 'OG011', 'title': 'Selinexor (70 mg/m^2)', 'description': 'Participants received selinexor dose of 70 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}, {'id': 'OG012', 'title': 'Selinexor (80 mg/m^2)', 'description': 'Participants received selinexor dose of 80 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}], 'classes': [{'categories': [{'measurements': [{'value': '348', 'spread': 'NA', 'comment': 'Geometric CV was not calculated as data were available for only two participants.', 'groupId': 'OG000'}, {'value': '733', 'spread': 'NA', 'comment': 'Geometric CV was not calculated as data were available for only two participants.', 'groupId': 'OG001'}, {'value': '1529', 'spread': '18.7', 'groupId': 'OG002'}, {'value': '1867', 'spread': '23.6', 'groupId': 'OG003'}, {'value': '2645', 'spread': '1111', 'groupId': 'OG004'}, {'value': '3513', 'spread': '26.0', 'groupId': 'OG005'}, {'value': '3948', 'spread': '28.6', 'groupId': 'OG006'}, {'value': '4552', 'spread': '23.7', 'groupId': 'OG007'}, {'value': '5284', 'spread': '21.0', 'groupId': 'OG008'}, {'value': '6089', 'spread': '32.3', 'groupId': 'OG009'}, {'value': '6964', 'spread': '12.2', 'groupId': 'OG010'}, {'value': '7803', 'spread': '8.5', 'groupId': 'OG011'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and CV were not calculated as data were available for only one participant.', 'groupId': 'OG012'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2', 'description': 'AUC0-inf was defined as the area under the concentration-time curve from time zero to infinity (extrapolated).', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for C1D1 could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution Uncorrected for Fraction Absorbed (Vd/F) of Selinexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Selinexor (3 mg/m^2)', 'description': 'Participants received selinexor dose of 3 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG001', 'title': 'Selinexor (6 mg/m^2)', 'description': 'Participants received selinexor dose of 6 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG002', 'title': 'Selinexor (12 mg/m^2)', 'description': 'Participants received selinexor dose of 12 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG003', 'title': 'Selinexor (16.8 mg/m^2)', 'description': 'Participants received selinexor dose of 16.8 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 15, 17, 19, and 22 in schedule 2.'}, {'id': 'OG004', 'title': 'Selinexor (23 mg/m^2)', 'description': 'Participants received selinexor dose of 23 mg/m\\^2 orally at Cycle 1, on Day 1 and 2 of each week for a 28-day cycle in schedule 4.'}, {'id': 'OG005', 'title': 'Selinexor (30 mg/m^2)', 'description': 'Participants received selinexor dose of 30 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 4, 8, 10, 15 and 17 in schedule 3, 5 and 9.'}, {'id': 'OG006', 'title': 'Selinexor (35 mg/m^2)', 'description': 'Participants received selinexor dose of 35 mg/m\\^2 orally at Cycle 1, on Day 1 and 3 in schedule 6.'}, {'id': 'OG007', 'title': 'Selinexor (40 mg/m^2)', 'description': 'Participants received selinexor dose of 40 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 8 and 11.'}, {'id': 'OG008', 'title': 'Selinexor (46 mg/m^2)', 'description': 'Participants received selinexor dose of 46 mg/m\\^2 orally at Cycle 1, on Day 1 once-weekly in schedule 7.'}, {'id': 'OG009', 'title': 'Selinexor (55 mg/m^2)', 'description': 'Participants received selinexor dose of 55 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, and 10, followed by an 18-day treatment-free interval (Days 11 through 28) in schedule 10.'}, {'id': 'OG010', 'title': 'Selinexor (60 mg/m^2)', 'description': 'Participants received selinexor dose of 60 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}, {'id': 'OG011', 'title': 'Selinexor (70 mg/m^2)', 'description': 'Participants received selinexor dose of 70 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}, {'id': 'OG012', 'title': 'Selinexor (80 mg/m^2)', 'description': 'Participants received selinexor dose of 80 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': 'NA', 'comment': 'Geometric CV was not calculated as data were available for only two participants.', 'groupId': 'OG000'}, {'value': '1.5', 'spread': 'NA', 'comment': 'Geometric CV was not calculated as data were available for only two participants.', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '21.2', 'groupId': 'OG002'}, {'value': '1.9', 'spread': '29.9', 'groupId': 'OG003'}, {'value': '1.9', 'spread': '34.1', 'groupId': 'OG004'}, {'value': '1.7', 'spread': '24.1', 'groupId': 'OG005'}, {'value': '2.0', 'spread': '30.3', 'groupId': 'OG006'}, {'value': '1.7', 'spread': '29.1', 'groupId': 'OG007'}, {'value': '1.8', 'spread': '12.9', 'groupId': 'OG008'}, {'value': '1.9', 'spread': '27.9', 'groupId': 'OG009'}, {'value': '1.6', 'spread': '23.0', 'groupId': 'OG010'}, {'value': '1.7', 'spread': '13.4', 'groupId': 'OG011'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and CV were not calculated as data were available for only one participant.', 'groupId': 'OG012'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2', 'description': 'Apparent volume of distribution was calculated as Dose/ (kel \\*AUC0-inf), uncorrected for fraction absorbed, reported normalized by participant body weight (kilogram \\[kg\\]).', 'unitOfMeasure': 'Liter per kilogram (L/kg)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for C1D1 could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Apparent Total Body Clearance, Uncorrected for Fraction Absorbed (Cl/F) of Selinexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Selinexor (3 mg/m^2)', 'description': 'Participants received selinexor dose of 3 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG001', 'title': 'Selinexor (6 mg/m^2)', 'description': 'Participants received selinexor dose of 6 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG002', 'title': 'Selinexor (12 mg/m^2)', 'description': 'Participants received selinexor dose of 12 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG003', 'title': 'Selinexor (16.8 mg/m^2)', 'description': 'Participants received selinexor dose of 16.8 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 15, 17, 19, and 22 in schedule 2.'}, {'id': 'OG004', 'title': 'Selinexor (23 mg/m^2)', 'description': 'Participants received selinexor dose of 23 mg/m\\^2 orally at Cycle 1, on Day 1 and 2 of each week for a 28-day cycle in schedule 4.'}, {'id': 'OG005', 'title': 'Selinexor (30 mg/m^2)', 'description': 'Participants received selinexor dose of 30 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 4, 8, 10, 15 and 17 in schedule 3, 5 and 9.'}, {'id': 'OG006', 'title': 'Selinexor (35 mg/m^2)', 'description': 'Participants received selinexor dose of 35 mg/m\\^2 orally at Cycle 1, on Day 1 and 3 in schedule 6.'}, {'id': 'OG007', 'title': 'Selinexor (40 mg/m^2)', 'description': 'Participants received selinexor dose of 40 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 8 and 11.'}, {'id': 'OG008', 'title': 'Selinexor (46 mg/m^2)', 'description': 'Participants received selinexor dose of 46 mg/m\\^2 orally at Cycle 1, on Day 1 once-weekly in schedule 7.'}, {'id': 'OG009', 'title': 'Selinexor (55 mg/m^2)', 'description': 'Participants received selinexor dose of 55 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, and 10, followed by an 18-day treatment-free interval (Days 11 through 28) in schedule 10.'}, {'id': 'OG010', 'title': 'Selinexor (60 mg/m^2)', 'description': 'Participants received selinexor dose of 60 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}, {'id': 'OG011', 'title': 'Selinexor (70 mg/m^2)', 'description': 'Participants received selinexor dose of 70 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}, {'id': 'OG012', 'title': 'Selinexor (80 mg/m^2)', 'description': 'Participants received selinexor dose of 80 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.19', 'spread': 'NA', 'comment': 'Geometric CV was not calculated as data were available for only two participants.', 'groupId': 'OG000'}, {'value': '0.21', 'spread': 'NA', 'comment': 'Geometric CV was not calculated as data were available for only two participants.', 'groupId': 'OG001'}, {'value': '0.21', 'spread': '26.6', 'groupId': 'OG002'}, {'value': '0.22', 'spread': '22.8', 'groupId': 'OG003'}, {'value': '0.20', 'spread': '54.9', 'groupId': 'OG004'}, {'value': '0.21', 'spread': '25.3', 'groupId': 'OG005'}, {'value': '0.22', 'spread': '25.9', 'groupId': 'OG006'}, {'value': '0.23', 'spread': '26.2', 'groupId': 'OG007'}, {'value': '0.22', 'spread': '12.9', 'groupId': 'OG008'}, {'value': '0.20', 'spread': '24.6', 'groupId': 'OG009'}, {'value': '0.19', 'spread': '27.5', 'groupId': 'OG010'}, {'value': '0.22', 'spread': '7.8', 'groupId': 'OG011'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and CV were not calculated as data were available for only one participant.', 'groupId': 'OG012'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2', 'description': 'Cl/F was calculated as Dose/AUC0-inf, uncorrected for fraction absorbed, reported normalized by participant body weight (kg).', 'unitOfMeasure': 'Liter per hour per kilogram (L/h/kg)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for C1D1 could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Terminal Half-Life (t½) of Selinexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Selinexor (3 mg/m^2)', 'description': 'Participants received selinexor dose of 3 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG001', 'title': 'Selinexor (6 mg/m^2)', 'description': 'Participants received selinexor dose of 6 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG002', 'title': 'Selinexor (12 mg/m^2)', 'description': 'Participants received selinexor dose of 12 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.'}, {'id': 'OG003', 'title': 'Selinexor (16.8 mg/m^2)', 'description': 'Participants received selinexor dose of 16.8 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 15, 17, 19, and 22 in schedule 2.'}, {'id': 'OG004', 'title': 'Selinexor (23 mg/m^2)', 'description': 'Participants received selinexor dose of 23 mg/m\\^2 orally at Cycle 1, on Day 1 and 2 of each week for a 28-day cycle in schedule 4.'}, {'id': 'OG005', 'title': 'Selinexor (30 mg/m^2)', 'description': 'Participants received selinexor dose of 30 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 4, 8, 10, 15 and 17 in schedule 3, 5 and 9.'}, {'id': 'OG006', 'title': 'Selinexor (35 mg/m^2)', 'description': 'Participants received selinexor dose of 35 mg/m\\^2 orally at Cycle 1, on Day 1 and 3 in schedule 6.'}, {'id': 'OG007', 'title': 'Selinexor (40 mg/m^2)', 'description': 'Participants received selinexor dose of 40 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 8 and 11.'}, {'id': 'OG008', 'title': 'Selinexor (46 mg/m^2)', 'description': 'Participants received selinexor dose of 46 mg/m\\^2 orally at Cycle 1, on Day 1 once-weekly in schedule 7.'}, {'id': 'OG009', 'title': 'Selinexor (55 mg/m^2)', 'description': 'Participants received selinexor dose of 55 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, and 10, followed by an 18-day treatment-free interval (Days 11 through 28) in schedule 10.'}, {'id': 'OG010', 'title': 'Selinexor (60 mg/m^2)', 'description': 'Participants received selinexor dose of 60 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}, {'id': 'OG011', 'title': 'Selinexor (70 mg/m^2)', 'description': 'Participants received selinexor dose of 70 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}, {'id': 'OG012', 'title': 'Selinexor (80 mg/m^2)', 'description': 'Participants received selinexor dose of 80 mg/m\\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median value was not calculated due to insufficient PK samples required for calculation.', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '6.1'}, {'value': 'NA', 'comment': 'Median value was not calculated due to insufficient PK samples required for calculation.', 'groupId': 'OG001', 'lowerLimit': '4.4', 'upperLimit': '5.1'}, {'value': '6.2', 'groupId': 'OG002', 'lowerLimit': '4.2', 'upperLimit': '7.8'}, {'value': '6.1', 'groupId': 'OG003', 'lowerLimit': '3.1', 'upperLimit': '8.7'}, {'value': '6.9', 'groupId': 'OG004', 'lowerLimit': '3.5', 'upperLimit': '12.0'}, {'value': '5.8', 'groupId': 'OG005', 'lowerLimit': '3.9', 'upperLimit': '8.4'}, {'value': '6.2', 'groupId': 'OG006', 'lowerLimit': '4.6', 'upperLimit': '10.4'}, {'value': '4.8', 'groupId': 'OG007', 'lowerLimit': '2.7', 'upperLimit': '9.8'}, {'value': '5.7', 'groupId': 'OG008', 'lowerLimit': '4.1', 'upperLimit': '6.8'}, {'value': '6.6', 'groupId': 'OG009', 'lowerLimit': '5.4', 'upperLimit': '10.1'}, {'value': '5.9', 'groupId': 'OG010', 'lowerLimit': '4.3', 'upperLimit': '5.9'}, {'value': '5.2', 'groupId': 'OG011', 'lowerLimit': '5.0', 'upperLimit': '6.0'}, {'value': 'NA', 'comment': 'Median value was not calculated due to insufficient PK samples required for calculation.', 'groupId': 'OG012', 'lowerLimit': '5.5', 'upperLimit': '5.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2', 'description': 't½ was, calculated as ln(2)/kel, where kel is elimination rate constant, calculated using linear regression on the terminal portion of the log-linear concentration versus time curve.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for C1D1 could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Overall Response of Selinexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '95', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Diffuse Large B-cell Lymphoma (DLBCL)', 'description': 'Participants with DLBCL received Selinexor in different Schedules; Schedule 1: \\<= 12 milligram per square meter (mg/m\\^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \\> 12 mg/m\\^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.'}, {'id': 'OG001', 'title': 'Non-Hodgkin Lymphoma (NHL) Excluding DLBCL', 'description': 'Participants with NHL received Selinexor in different Schedules; Schedule 1: \\<= 12 mg/m\\^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \\> 12 mg/m\\^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly \\[1 Day between doses\\] during weeks 1 and 2; Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.'}, {'id': 'OG002', 'title': 'Multiple Myeloma (MM)', 'description': 'Participants with MM received Selinexor in different Schedules; Schedule 1: \\<= 12 mg/m\\^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m\\^2 total) in the 1-week run-in period; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: \\>= 35 mg/m\\^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.'}, {'id': 'OG003', 'title': 'Acute Myeloid Leukemia (AML)', 'description': 'Participants with AML received Selinexor in different Schedules; Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: \\>= 55 mg/m\\^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.'}, {'id': 'OG004', 'title': 'Other Hematological Malignancies (ALL, CML and CLL)', 'description': 'Participants with other hematological malignancies (Acute lymphoblastic leukemia \\[ALL\\], Chronic myelogenous leukemia \\[CML\\] and chronic lymphocytic leukemia \\[CLL\\]) received Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly \\[1 day between doses\\]; Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.'}], 'classes': [{'title': 'Complete response', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Partial response', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Morphologic complete remission', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Partial remission', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Complete cytogenetic response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Complete hematological response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug administration to end of treatment (up to 27 months)', 'description': 'Objective response for each malignancy was defined using the disease response criteria by malignancy; For NHL (including DLBCL, PTCL, and CTCL), objective response included complete response (CR) and partial response (PR). For MM, objective response included stringent complete response (sCR), CR, very good partial response (VGPR), and PR. For WM, objective response included CR, VGPR, and PR. For CLL, ALL, and AML, objective response included complete remission and Partial remission. For CML, objective response includes complete cytogenic response, and complete hematologic response (CHR).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis included all participants registered to the study who had either completed 1 cycle of treatment or discontinued treatment prior to completing the first cycle due to documented disease progression, death related to disease, or treatment-related toxicity.'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Diffuse Large B-cell Lymphoma (DLBCL)', 'description': 'Participants with DLBCL received Selinexor in different Schedules; Schedule 1: \\<= 12 milligram per square meter (mg/m\\^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \\> 12 mg/m\\^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.'}, {'id': 'OG001', 'title': 'Non-Hodgkin Lymphoma (NHL) Excluding DLBCL', 'description': 'Participants with NHL received Selinexor in different Schedules; Schedule 1: \\<= 12 mg/m\\^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \\> 12 mg/m\\^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly \\[1 Day between doses\\] during weeks 1 and 2; Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.'}, {'id': 'OG002', 'title': 'Multiple Myeloma (MM)', 'description': 'Participants with MM received Selinexor in different Schedules; Schedule 1: \\<= 12 mg/m\\^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m\\^2 total) in the 1-week run-in period; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: \\>= 35 mg/m\\^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.'}, {'id': 'OG003', 'title': 'Acute Myeloid Leukemia (AML)', 'description': 'Participants with AML received Selinexor in different Schedules; Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: \\>= 55 mg/m\\^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.'}, {'id': 'OG004', 'title': 'Other Hematological Malignancies (ALL, CML and CLL)', 'description': 'Participants with other hematological malignancies (Acute lymphoblastic leukemia \\[ALL\\], Chronic myelogenous leukemia \\[CML\\] and chronic lymphocytic leukemia \\[CLL\\]) received Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly \\[1 day between doses\\]; Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '335.5', 'comment': 'Upper limit of 95% Confidence Interval (CI) was not estimable due to less than 50% death events.', 'groupId': 'OG000', 'lowerLimit': '48', 'upperLimit': 'NA'}, {'value': '251', 'comment': 'Upper limit of 95% CI was not estimable due to less than 50% death events.', 'groupId': 'OG001', 'lowerLimit': '36', 'upperLimit': 'NA'}, {'value': '180', 'comment': 'Upper limit of 95% CI was not estimable due to less than 50% death events.', 'groupId': 'OG002', 'lowerLimit': '57', 'upperLimit': 'NA'}, {'value': '76', 'comment': 'Upper limit of 95% CI was not estimable due to less than 50% death events.', 'groupId': 'OG003', 'lowerLimit': '29', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and limits of 95% CI were not estimable due to less than 50% death events.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug administration to end of treatment (up to 27 months)', 'description': 'Duration of response was defined as the time from the first occurrence of objective response to first documented evidence of disease recurrence or progression. Participants without evidence of progression were censored at time of last evaluable disease assessment. Objective response was defined as any response of partial response/remission or better for all malignancies; for AML, a response of morphologic leukemia-free state is also included for ORR. Duration of response was calculated by Kaplan-Meier method.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy analysis included all participants who had either completed 1 cycle of treatment or discontinued treatment prior to completing the first cycle due to documented disease progression, death related to disease, or treatment-related toxicity. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '95', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Diffuse Large B-cell Lymphoma (DLBCL)', 'description': 'Participants with DLBCL received Selinexor in different Schedules; Schedule 1: \\<= 12 milligram per square meter (mg/m\\^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \\> 12 mg/m\\^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.'}, {'id': 'OG001', 'title': 'Non-Hodgkin Lymphoma (NHL) Excluding DLBCL', 'description': 'Participants with NHL received Selinexor in different Schedules; Schedule 1: \\<= 12 mg/m\\^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \\> 12 mg/m\\^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly \\[1 Day between doses\\] during weeks 1 and 2; Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.'}, {'id': 'OG002', 'title': 'Multiple Myeloma (MM)', 'description': 'Participants with MM received Selinexor in different Schedules; Schedule 1: \\<= 12 mg/m\\^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m\\^2 total) in the 1-week run-in period; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: \\>= 35 mg/m\\^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.'}, {'id': 'OG003', 'title': 'Acute Myeloid Leukemia (AML)', 'description': 'Participants with AML received Selinexor in different Schedules; Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: \\>= 55 mg/m\\^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.'}, {'id': 'OG004', 'title': 'Other Hematological Malignancies (ALL, CML and CLL)', 'description': 'Participants with other hematological malignancies (Acute lymphoblastic leukemia \\[ALL\\], Chronic myelogenous leukemia \\[CML\\] and chronic lymphocytic leukemia \\[CLL\\]) received Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly \\[1 day between doses\\]; Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '31', 'upperLimit': '56'}, {'value': '110', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '274'}, {'value': '57', 'groupId': 'OG002', 'lowerLimit': '36', 'upperLimit': '88'}, {'value': '44', 'groupId': 'OG003', 'lowerLimit': '36', 'upperLimit': '52'}, {'value': '57', 'groupId': 'OG004', 'lowerLimit': '24', 'upperLimit': '222'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 1 to End of Treatment (up to 27 months)', 'description': 'Progression-free survival (PFS) was calculated from the date of first dose of study drug to first documented evidence of disease recurrence or progression or death due to any cause. Participants who were last known to be alive and without evidence of progression were censored at time of last evaluable disease assessment. If date of progression or death occurred after more than 1 missed disease assessment interval, participants were censored at the time of last evaluable disease assessment prior to the missed assessment.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis included all participants registered to the study who had either completed 1 cycle of treatment or discontinued treatment prior to completing the first cycle due to documented disease progression, death related to disease, or treatment-related toxicity.'}, {'type': 'SECONDARY', 'title': 'Duration of at Least Stable Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '95', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Diffuse Large B-cell Lymphoma (DLBCL)', 'description': 'Participants with DLBCL received Selinexor in different Schedules; Schedule 1: \\<= 12 milligram per square meter (mg/m\\^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \\> 12 mg/m\\^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.'}, {'id': 'OG001', 'title': 'Non-Hodgkin Lymphoma (NHL) Excluding DLBCL', 'description': 'Participants with NHL received Selinexor in different Schedules; Schedule 1: \\<= 12 mg/m\\^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \\> 12 mg/m\\^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly \\[1 Day between doses\\] during weeks 1 and 2; Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.'}, {'id': 'OG002', 'title': 'Multiple Myeloma (MM)', 'description': 'Participants with MM received Selinexor in different Schedules; Schedule 1: \\<= 12 mg/m\\^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m\\^2 total) in the 1-week run-in period; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: \\>= 35 mg/m\\^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.'}, {'id': 'OG003', 'title': 'Acute Myeloid Leukemia (AML)', 'description': 'Participants with AML received Selinexor in different Schedules; Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: \\>= 55 mg/m\\^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.'}, {'id': 'OG004', 'title': 'Other Hematological Malignancies (ALL, CML and CLL)', 'description': 'Participants with other hematological malignancies (Acute lymphoblastic leukemia \\[ALL\\], Chronic myelogenous leukemia \\[CML\\] and chronic lymphocytic leukemia \\[CLL\\]) received Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly \\[1 day between doses\\]; Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '79'}, {'value': '114', 'groupId': 'OG001', 'lowerLimit': '43', 'upperLimit': '415'}, {'value': '57', 'groupId': 'OG002', 'lowerLimit': '43', 'upperLimit': '100'}, {'value': '80', 'groupId': 'OG003', 'lowerLimit': '52', 'upperLimit': '101'}, {'value': '64', 'groupId': 'OG004', 'lowerLimit': '21', 'upperLimit': '283'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 1 to End of Treatment (up to 27 months)', 'description': 'Duration of at least stable disease was defined as the time from the date of first dose of study drug to first documented evidence of disease recurrence or progression. Participants without evidence of progression were censored at time of last evaluable disease assessment.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis included all participants registered to the study who had either completed 1 cycle of treatment or discontinued treatment prior to completing the first cycle due to documented disease progression, death related to disease, or treatment-related toxicity.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '95', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Diffuse Large B-cell Lymphoma (DLBCL)', 'description': 'Participants with DLBCL received Selinexor in different Schedules; Schedule 1: \\<= 12 milligram per square meter (mg/m\\^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \\> 12 mg/m\\^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.'}, {'id': 'OG001', 'title': 'Non-Hodgkin Lymphoma (NHL) Excluding DLBCL', 'description': 'Participants with NHL received Selinexor in different Schedules; Schedule 1: \\<= 12 mg/m\\^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \\> 12 mg/m\\^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly \\[1 Day between doses\\] during weeks 1 and 2; Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.'}, {'id': 'OG002', 'title': 'Multiple Myeloma (MM)', 'description': 'Participants with MM received Selinexor in different Schedules; Schedule 1: \\<= 12 mg/m\\^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m\\^2 total) in the 1-week run-in period; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: \\>= 35 mg/m\\^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.'}, {'id': 'OG003', 'title': 'Acute Myeloid Leukemia (AML)', 'description': 'Participants with AML received Selinexor in different Schedules; Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: \\>= 55 mg/m\\^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.'}, {'id': 'OG004', 'title': 'Other Hematological Malignancies (ALL, CML and CLL)', 'description': 'Participants with other hematological malignancies (Acute lymphoblastic leukemia \\[ALL\\], Chronic myelogenous leukemia \\[CML\\] and chronic lymphocytic leukemia \\[CLL\\]) received Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly \\[1 day between doses\\]; Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '138', 'comment': 'Upper limit of 95% CI was not estimable due to less than 50% death events.', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': 'NA'}, {'value': '423', 'comment': 'Upper limit of 95% CI was not estimable due to less than 50% death events.', 'groupId': 'OG001', 'lowerLimit': '423', 'upperLimit': 'NA'}, {'value': '366', 'comment': 'Upper limit of 95% CI was not estimable due to less than 50% death events.', 'groupId': 'OG002', 'lowerLimit': '126', 'upperLimit': 'NA'}, {'value': '76', 'groupId': 'OG003', 'lowerLimit': '48', 'upperLimit': '114'}, {'value': '82', 'comment': 'Upper limit of 95% CI was not estimable due to less than 50% death events.', 'groupId': 'OG004', 'lowerLimit': '50', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 1 to End of Treatment (up to 27 months)', 'description': 'Overall Survival was calculated from the date of first dose of study drug to date of death due to any cause. Participants who were last known to be alive were censored at time of last contact. Overall survival was calculated by Kaplan-Meier method.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis included all participants registered to the study who had either completed 1 cycle of treatment or discontinued treatment prior to completing the first cycle due to documented disease progression, death related to disease, or treatment-related toxicity.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diffuse Large B-cell Lymphoma (DLBCL)', 'description': 'Participants with DLBCL received Selinexor in different Schedules; Schedule 1: \\<= 12 milligram per square meter (mg/m\\^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \\> 12 mg/m\\^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.'}, {'id': 'FG001', 'title': 'Non-Hodgkin Lymphoma (NHL) Excluding DLBCL', 'description': 'Participants with NHL received Selinexor in different Schedules; Schedule 1: \\<= 12 mg/m\\^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \\> 12 mg/m\\^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly \\[1 Day between doses\\] during weeks 1 and 2; Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.'}, {'id': 'FG002', 'title': 'Multiple Myeloma (MM)', 'description': 'Participants with MM received Selinexor in different Schedules; Schedule 1: \\<= 12 mg/m\\^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m\\^2 total) in the 1-week run-in period; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: \\>= 35 mg/m\\^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.'}, {'id': 'FG003', 'title': 'Acute Myeloid Leukemia (AML)', 'description': 'Participants with AML received Selinexor in different Schedules; Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: \\>= 55 mg/m\\^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.'}, {'id': 'FG004', 'title': 'Other Hematological Malignancies (ALL, CML and CLL)', 'description': 'Participants with other hematological malignancies (Acute lymphoblastic leukemia \\[ALL\\], Chronic myelogenous leukemia \\[CML\\] and chronic lymphocytic leukemia \\[CLL\\]) received Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly \\[1 day between doses\\]; Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '81'}, {'groupId': 'FG003', 'numSubjects': '95'}, {'groupId': 'FG004', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '81'}, {'groupId': 'FG003', 'numSubjects': '95'}, {'groupId': 'FG004', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Need of treatment not allowed per protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Investigator discretion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other treatments became available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Intercurrent illness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Non-Compliance with study procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Consent withdrawn by participant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '57'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'Incidence or severity of Adverse events', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'The study was conducted at 12 sites in United States, Canada and Europe between 23 July 2012 (first participant treated) and 13 October 2015 (last participant completed).', 'preAssignmentDetails': 'A total of 286 participants were enrolled out of which 1 participants with MM never treated due to disease progression prior to dose initiation and 285 participants received treatment in 11 different schedules. The schedules were either 28 days (Schedules 1-7, 9-11) or 21 days (Schedule 8) per cycle and participants were treated once weekly (Schedule 7), twice weekly (Schedules 3-6, 8-11) or three times weekly alternating with 2 times weekly (Schedules 1, 2).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '285', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Diffuse Large B-cell Lymphoma (DLBCL)', 'description': 'Participants with DLBCL received Selinexor in different Schedules; Schedule 1: \\<= 12 milligram per square meter (mg/m\\^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \\> 12 mg/m\\^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.'}, {'id': 'BG001', 'title': 'Non-Hodgkin Lymphoma (NHL) Excluding DLBCL', 'description': 'Participants with NHL received Selinexor in different Schedules; Schedule 1: \\<= 12 mg/m\\^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \\> 12 mg/m\\^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly \\[1 Day between doses\\] during weeks 1 and 2; Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.'}, {'id': 'BG002', 'title': 'Multiple Myeloma (MM)', 'description': 'Participants with MM received Selinexor in different Schedules; Schedule 1: \\<= 12 mg/m\\^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m\\^2 total) in the 1-week run-in period; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: \\>= 35 mg/m\\^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.'}, {'id': 'BG003', 'title': 'Acute Myeloid Leukemia (AML)', 'description': 'Participants with AML received Selinexor in different Schedules; Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly (1 day between doses); Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \\>=40 mg/m\\^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: \\>= 55 mg/m\\^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.'}, {'id': 'BG004', 'title': 'Other Hematological Malignancies (ALL, CML and CLL)', 'description': 'Participants with other hematological malignancies (Acute lymphoblastic leukemia \\[ALL\\], Chronic myelogenous leukemia \\[CML\\] and chronic lymphocytic leukemia \\[CLL\\]) received Schedule 2: \\> 12 mg/m\\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \\>=30 mg/m\\^2 PO twice weekly \\[1 day between doses\\]; Schedule 4: \\>=23 mg/m\\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \\>=30 mg/m\\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: \\>=45 mg/m\\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: \\>=45 mg/m\\^2 PO twice weekly in combination with 375 mg/m\\^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.8', 'spread': '14.00', 'groupId': 'BG000'}, {'value': '58.0', 'spread': '15.90', 'groupId': 'BG001'}, {'value': '62.1', 'spread': '8.76', 'groupId': 'BG002'}, {'value': '65.6', 'spread': '15.33', 'groupId': 'BG003'}, {'value': '60.9', 'spread': '15.23', 'groupId': 'BG004'}, {'value': '61.9', 'spread': '13.79', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '123', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '162', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '258', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '248', 'groupId': 'BG005'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'categories': [{'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'}]}]}, {'title': 'American Indian or Alaskan Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}, {'title': 'Unknown/Not Reported', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population consisted of all participants who received at least 1 dose of selinexor.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 286}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2015-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-24', 'studyFirstSubmitDate': '2012-05-16', 'resultsFirstSubmitDate': '2021-02-01', 'studyFirstSubmitQcDate': '2012-05-25', 'lastUpdatePostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-05', 'studyFirstPostDateStruct': {'date': '2012-05-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From first dose of study drug administration to end of treatment (up to 27 months)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product during the course of a study and which does not necessarily have to have a causal relationship with this treatment. An Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death; life-threatening event; required or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. TEAEs are any untoward medical incidence in a participant during administered study treatment, whether or not these events were related to study treatment.'}, {'measure': 'Recommended Phase 2 Dose (RP2D) of Selinexor', 'timeFrame': 'From first dose of study drug administration to end of treatment (up to 27 months)', 'description': 'Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD was defined as the next lower dose level below the one in which \\> 1 of 3 participants or ≥ 2 of 6 participants experienced dose-limiting toxicity (DLT), provided that that dose level is ≤25% lower than the highest dose tested. If the projected MTD was \\>25% lower than the highest dose tested, then an additional cohort of ≥3 participants were added at a dose that was intermediate between the intolerable dose and the next lower dose.'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) of Selinexor', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2', 'description': 'Cmax was defined as the maximum observed concentration, taken directly from the plasma concentration.'}, {'measure': 'Time to Maximum Observed Concentration (Tmax) of Selinexor', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2', 'description': 'Tmax was defined as time of first observation of Cmax, taken directly from the plasma concentration data.'}, {'measure': 'Average Concentration From Time 0 to 24 Hours (Cavg0-24h) of Selinexor', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2', 'description': 'Cavg0-24h was defined as average concentration from time 0 to 24 hours.'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 to t (AUC0-t) of Selinexor', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2', 'description': 'AUC0-t was defined as area under the concentration-time curve from time zero to the last non-zero concentration.'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selinexor', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2', 'description': 'AUC0-inf was defined as the area under the concentration-time curve from time zero to infinity (extrapolated).'}, {'measure': 'Apparent Volume of Distribution Uncorrected for Fraction Absorbed (Vd/F) of Selinexor', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2', 'description': 'Apparent volume of distribution was calculated as Dose/ (kel \\*AUC0-inf), uncorrected for fraction absorbed, reported normalized by participant body weight (kilogram \\[kg\\]).'}, {'measure': 'Apparent Total Body Clearance, Uncorrected for Fraction Absorbed (Cl/F) of Selinexor', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2', 'description': 'Cl/F was calculated as Dose/AUC0-inf, uncorrected for fraction absorbed, reported normalized by participant body weight (kg).'}, {'measure': 'Terminal Half-Life (t½) of Selinexor', 'timeFrame': '0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2', 'description': 't½ was, calculated as ln(2)/kel, where kel is elimination rate constant, calculated using linear regression on the terminal portion of the log-linear concentration versus time curve.'}, {'measure': 'Number of Participants With Overall Response of Selinexor', 'timeFrame': 'From first dose of study drug administration to end of treatment (up to 27 months)', 'description': 'Objective response for each malignancy was defined using the disease response criteria by malignancy; For NHL (including DLBCL, PTCL, and CTCL), objective response included complete response (CR) and partial response (PR). For MM, objective response included stringent complete response (sCR), CR, very good partial response (VGPR), and PR. For WM, objective response included CR, VGPR, and PR. For CLL, ALL, and AML, objective response included complete remission and Partial remission. For CML, objective response includes complete cytogenic response, and complete hematologic response (CHR).'}, {'measure': 'Duration of Response', 'timeFrame': 'From first dose of study drug administration to end of treatment (up to 27 months)', 'description': 'Duration of response was defined as the time from the first occurrence of objective response to first documented evidence of disease recurrence or progression. Participants without evidence of progression were censored at time of last evaluable disease assessment. Objective response was defined as any response of partial response/remission or better for all malignancies; for AML, a response of morphologic leukemia-free state is also included for ORR. Duration of response was calculated by Kaplan-Meier method.'}, {'measure': 'Progression-free Survival', 'timeFrame': 'Cycle 1 Day 1 to End of Treatment (up to 27 months)', 'description': 'Progression-free survival (PFS) was calculated from the date of first dose of study drug to first documented evidence of disease recurrence or progression or death due to any cause. Participants who were last known to be alive and without evidence of progression were censored at time of last evaluable disease assessment. If date of progression or death occurred after more than 1 missed disease assessment interval, participants were censored at the time of last evaluable disease assessment prior to the missed assessment.'}, {'measure': 'Duration of at Least Stable Disease', 'timeFrame': 'Cycle 1 Day 1 to End of Treatment (up to 27 months)', 'description': 'Duration of at least stable disease was defined as the time from the date of first dose of study drug to first documented evidence of disease recurrence or progression. Participants without evidence of progression were censored at time of last evaluable disease assessment.'}, {'measure': 'Overall Survival', 'timeFrame': 'Cycle 1 Day 1 to End of Treatment (up to 27 months)', 'description': 'Overall Survival was calculated from the date of first dose of study drug to date of death due to any cause. Participants who were last known to be alive were censored at time of last contact. Overall survival was calculated by Kaplan-Meier method.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Selinexor', 'KPT-330', 'Multiple Myeloma', 'non-Hodgkin Lymphoma', 'Chronic Lymphocytic Leukemia', "Waldenström's macroglobulinemia", 'Peripheral T-Cell Lymphoma', 'Cutaneous T-Cell Lymphoma', 'Chronic Myelocytic Leukemia', 'Acute Lymphoblastic Leukemia'], 'conditions': ['Hematological Malignancies']}, 'referencesModule': {'references': [{'pmid': '29203585', 'type': 'DERIVED', 'citation': 'Chen C, Siegel D, Gutierrez M, Jacoby M, Hofmeister CC, Gabrail N, Baz R, Mau-Sorensen M, Berdeja JG, Savona M, Savoie L, Trudel S, Areethamsirikul N, Unger TJ, Rashal T, Hanke T, Kauffman M, Shacham S, Reece D. Safety and efficacy of selinexor in relapsed or refractory multiple myeloma and Waldenstrom macroglobulinemia. Blood. 2018 Feb 22;131(8):855-863. doi: 10.1182/blood-2017-08-797886. Epub 2017 Dec 4.'}, {'pmid': '28468797', 'type': 'DERIVED', 'citation': 'Kuruvilla J, Savona M, Baz R, Mau-Sorensen PM, Gabrail N, Garzon R, Stone R, Wang M, Savoie L, Martin P, Flinn I, Jacoby M, Unger TJ, Saint-Martin JR, Rashal T, Friedlander S, Carlson R, Kauffman M, Shacham S, Gutierrez M. Selective inhibition of nuclear export with selinexor in patients with non-Hodgkin lymphoma. Blood. 2017 Jun 15;129(24):3175-3183. doi: 10.1182/blood-2016-11-750174. Epub 2017 May 3.'}, {'pmid': '28336527', 'type': 'DERIVED', 'citation': 'Garzon R, Savona M, Baz R, Andreeff M, Gabrail N, Gutierrez M, Savoie L, Mau-Sorensen PM, Wagner-Johnston N, Yee K, Unger TJ, Saint-Martin JR, Carlson R, Rashal T, Kashyap T, Klebanov B, Shacham S, Kauffman M, Stone R. A phase 1 clinical trial of single-agent selinexor in acute myeloid leukemia. Blood. 2017 Jun 15;129(24):3165-3174. doi: 10.1182/blood-2016-11-750158. Epub 2017 Mar 23.'}, {'pmid': '23752175', 'type': 'DERIVED', 'citation': 'Schmidt J, Braggio E, Kortuem KM, Egan JB, Zhu YX, Xin CS, Tiedemann RE, Palmer SE, Garbitt VM, McCauley D, Kauffman M, Shacham S, Chesi M, Bergsagel PL, Stewart AK. Genome-wide studies in multiple myeloma identify XPO1/CRM1 as a critical target validated using the selective nuclear export inhibitor KPT-276. Leukemia. 2013 Dec;27(12):2357-65. doi: 10.1038/leu.2013.172. Epub 2013 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to find out more information relating to the highest dose of KCP-330 that can be given safely and side effects it may cause, to examine how the body affects KCP-330 concentrations in the blood (pharmacokinetics or PK), to examine the effects of KCP-330 on the body (pharmacodynamics or PDn) and to obtain information on its effectiveness in treating cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Malignancies that are refractory to or intolerant of established therapy known to provide clinical benefit. Patients must not be candidates for anti-tumor regimes known to provide clinical benefit.\n2. All patients must have evidence of progressive disease on study entry. Previously untreated patients who are not chemotherapy candidates on Arm 2 may have advanced disease (without clear progression). There is no upper limit on the number of prior treatments provided that all inclusion criteria are met, and exclusion criteria are not met.\n\nExclusion Criteria\n\n1. Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤2 weeks prior to cycle 1 day 1 and mitomycin C and radioimmunotherapy 6 weeks prior to cycle 1 day 1.\n2. Patients with active graft versus host disease after allogeneic stem cell transplantation. At least 3 months must have elapsed since completion of allogeneic stem cell transplantation except for patients with AML, where at least 2 months must have elapsed;\n3. Known active hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen);\n4. Patients with active CNS malignancy. Asymptomatic small lesions are not considered active. Treated lesions may be considered inactive if they are stable for at least 3 months. Patient with malignant cells in their cerebrospinal fluid (CSF) without CNS symptom may be included.\n5. Significantly diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea.\n6. Grade ≥2 peripheral neuropathy at baseline (within 14 days prior to cycle 1 day 1).\n7. Macular degeneration, uncontrolled glaucoma, or markedly decreased visual acuity.\n8. In the opinion of the investigator, patients who are significantly below their ideal body weight.'}, 'identificationModule': {'nctId': 'NCT01607892', 'briefTitle': 'Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced Hematological Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Karyopharm Therapeutics Inc'}, 'officialTitle': 'A Phase I Study of the Safety, Pharmacokinetics and Pharmacodynamics of Escalating Doses of the Selective Inhibitor of Nuclear Export/SINE™ Compound KPT-330 in Patients With Advanced Hematological Malignancies', 'orgStudyIdInfo': {'id': 'KCP-330-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'selinexor', 'interventionNames': ['Drug: KPT-330']}], 'interventions': [{'name': 'KPT-330', 'type': 'DRUG', 'otherNames': ['Selinexor'], 'armGroupLabels': ['selinexor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Gabrail Cancer Center Research', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'T2W 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'M5T 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karyopharm Therapeutics Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}