Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2026-03-02 @ 8:02 PM
Study NCT ID:
NCT01896505
Status:
COMPLETED
Last Update Posted:
2024-01-08
First Post:
2013-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D001859', 'term': 'Bone Neoplasms'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal 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': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From screening up to 30 days post last study drug dose (up to 39 months)', 'description': 'Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 milligrams per meter square (mg/m\\^2) orally twice weekly in treatment sequence ABCD (Treatment A: fasted, tablet formulation on Day 1 of Week 1; Treatment B: high-fat meal, tablet formulation on Day 1 of Week 2; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 3; Treatment D: low-fat meal, capsule formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 2, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Arm 2:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 2, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Arm 3:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 17, 'seriousNumAtRisk': 17, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'Arm 4:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\\^2 orally in treatment sequence ABC (Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 1; Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 2; Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 3, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Arm 5:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\\^2 orally in treatment sequence CAB (Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 1; Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 2; Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 3, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Arm 6:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\\^2 orally in treatment sequence BCA (Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 1; Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 2; Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 2, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Left atrial enlargement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Periorbital oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Blepharospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vitreous detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 6, 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haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From the Time Zero to the Last Non-zero Concentration (AUC0-t) of Selinexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arms 1 and 2: Treatment A: Fasted, Tablet Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \\[Week 1\\] in Arm 1 and Day 1 \\[Week 2\\] in Arm 2).'}, {'id': 'OG001', 'title': 'Arms 1 and 2: Treatment B: High-Fat Meal, Tablet Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment B: high-fat meal, tablet formulation on Day 1 \\[Week 2\\] in Arm 1 and Day 1 \\[Week 1\\] in Arm 2).'}, {'id': 'OG002', 'title': 'Arms 1 and 2: Treatment C: Low-Fat Meal, Tablet Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment C: low-fat meal, tablet formulation on Day 1 \\[Week 3\\] in Arm 1 and Day 1 \\[Week 4\\] in Arm 2).'}, {'id': 'OG003', 'title': 'Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \\[Week 4\\] in Arm 1 and Day 1 \\[Week 3\\] in Arm 2).'}, {'id': 'OG004', 'title': 'Arms 4, 5, and 6: Treatment A: First Generation Tablet', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\\^2 orally in randomized treatment sequence (i.e. Treatment A: current \\[1st generation\\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).'}, {'id': 'OG005', 'title': 'Arms 4, 5, and 6: Treatment B: Second Generation Tablet', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\\^2 orally in randomized treatment sequence (i.e. Treatment B: new \\[2nd generation\\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).'}, {'id': 'OG006', 'title': 'Arms 4, 5, and 6: Treatment C: Oral Suspension', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).'}], 'classes': [{'categories': [{'measurements': [{'value': '2752', 'spread': '37.5', 'groupId': 'OG000'}, {'value': '3175', 'spread': '25.3', 'groupId': 'OG001'}, {'value': '3280', 'spread': '19.3', 'groupId': 'OG002'}, {'value': '3342', 'spread': '21.4', 'groupId': 'OG003'}, {'value': '4086', 'spread': '22.3', 'groupId': 'OG004'}, {'value': '4220', 'spread': '22.0', 'groupId': 'OG005'}, {'value': '3955', 'spread': '21.2', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10,18, 24, and 48 hours post-dose', 'description': 'AUC0-t was defined as area under the concentration-time curve from time zero to the last non-zero concentration.', 'unitOfMeasure': 'Nanograms*hour per milliliter (ng*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacokinetic (PK) population included all participants in Arms 1, 2 and Arms 4, 5, and 6 who received selinexor, and for whom the PK profile for all treatments could be adequately characterized. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. As pre-specified in SAP and protocol Arm 3 was a non-PK group assessment, so data was not collected and analyzed for this PK outcome."}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration Time Curve From the Time Zero to Extrapolated to Infinity (AUC0-inf) of Selinexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arms 1 and 2: Treatment A: Fasted, Tablet Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \\[Week 1\\] in Arm 1 and Day 1 \\[Week 2\\] in Arm 2).'}, {'id': 'OG001', 'title': 'Arms 1 and 2: Treatment B: High-Fat Meal, Tablet Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment B: high-fat meal, tablet formulation on Day 1 \\[Week 2\\] in Arm 1 and Day 1 \\[Week 1\\] in Arm 2).'}, {'id': 'OG002', 'title': 'Arms 1 and 2: Treatment C: Low-Fat Meal, Tablet Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment C: low-fat meal, tablet formulation on Day 1 \\[Week 3\\] in Arm 1 and Day 1 \\[Week 4\\] in Arm 2).'}, {'id': 'OG003', 'title': 'Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \\[Week 4\\] in Arm 1 and Day 1 \\[Week 3\\] in Arm 2).'}, {'id': 'OG004', 'title': 'Arms 4, 5, and 6: Treatment A: First Generation Tablet', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\\^2 orally in randomized treatment sequence (i.e. Treatment A: current \\[1st generation\\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).'}, {'id': 'OG005', 'title': 'Arms 4, 5, and 6: Treatment B: Second Generation Tablet', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\\^2 orally in randomized treatment sequence (i.e. Treatment B: new \\[2nd generation\\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).'}, {'id': 'OG006', 'title': 'Arms 4, 5, and 6: Treatment C: Oral Suspension', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).'}], 'classes': [{'categories': [{'measurements': [{'value': '2969', 'spread': '34.1', 'groupId': 'OG000'}, {'value': '3412', 'spread': '23.8', 'groupId': 'OG001'}, {'value': '3483', 'spread': '18.1', 'groupId': 'OG002'}, {'value': '3561', 'spread': '20.6', 'groupId': 'OG003'}, {'value': '4117', 'spread': '22.4', 'groupId': 'OG004'}, {'value': '4250', 'spread': '21.8', 'groupId': 'OG005'}, {'value': '4002', 'spread': '21.1', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose', 'description': 'AUC0-inf was defined as area under the concentration-time curve from time zero to infinity (extrapolated), AUC0-inf was calculated as AUC0-t + Ct/ elimination rate constant (kel), where: Ct = the last observed non- zero concentration.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population included all participants in Arms 1, 2 and Arms 4, 5, and 6 who received selinexor, and for whom the PK profile for all treatments could be adequately characterized. Here 'overall number of participants analyzed' signifies participants who are evaluable for this outcome measure. As pre-specified in SAP and protocol Arm 3 was a non-PK group assessment, so data was not collected and analyzed for this PK outcome."}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Selinexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arms 1 and 2: Treatment A: Fasted, Tablet Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \\[Week 1\\] in Arm 1 and Day 1 \\[Week 2\\] in Arm 2).'}, {'id': 'OG001', 'title': 'Arms 1 and 2: Treatment B: High-Fat Meal, Tablet Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment B: high-fat meal, tablet formulation on Day 1 \\[Week 2\\] in Arm 1 and Day 1 \\[Week 1\\] in Arm 2).'}, {'id': 'OG002', 'title': 'Arms 1 and 2: Treatment C: Low-Fat Meal, Tablet Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment C: low-fat meal, tablet formulation on Day 1 \\[Week 3\\] in Arm 1 and Day 1 \\[Week 4\\] in Arm 2).'}, {'id': 'OG003', 'title': 'Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \\[Week 4\\] in Arm 1 and Day 1 \\[Week 3\\] in Arm 2).'}, {'id': 'OG004', 'title': 'Arms 4, 5, and 6: Treatment A: First Generation Tablet', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\\^2 orally in randomized treatment sequence (i.e. Treatment A: current \\[1st generation\\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).'}, {'id': 'OG005', 'title': 'Arms 4, 5, and 6: Treatment B: Second Generation Tablet', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\\^2 orally in randomized treatment sequence (i.e. Treatment B: new \\[2nd generation\\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).'}, {'id': 'OG006', 'title': 'Arms 4, 5, and 6: Treatment C: Oral Suspension', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).'}], 'classes': [{'categories': [{'measurements': [{'value': '355', 'spread': '52.6', 'groupId': 'OG000'}, {'value': '404', 'spread': '39.1', 'groupId': 'OG001'}, {'value': '436', 'spread': '21.9', 'groupId': 'OG002'}, {'value': '429', 'spread': '29.1', 'groupId': 'OG003'}, {'value': '519', 'spread': '34.4', 'groupId': 'OG004'}, {'value': '527', 'spread': '30.7', 'groupId': 'OG005'}, {'value': '450', 'spread': '52.8', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose', 'description': 'Cmax was defined as maximum observed concentration, taken directly from the plasma concentration data.', 'unitOfMeasure': 'Nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population included all participants in Arms 1, 2 and Arms 4, 5, and 6 who received selinexor, and for whom the PK profile for all treatments could be adequately characterized. Here 'overall number of participants analyzed' signifies participants who are evaluable for this outcome measure. As pre-specified in SAP and protocol Arm 3 was a non-PK group assessment, so data was not collected and analyzed for this PK outcome."}, {'type': 'PRIMARY', 'title': 'Time of First Maximum Observed Concentration (Tmax) of Selinexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arms 1 and 2: Treatment A: Fasted, Tablet Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. (i.e. Treatment A: fasted, tablet formulation on Day 1 \\[Week 1\\] in Arm 1 and Day 1 \\[Week 2\\] in Arm 2).'}, {'id': 'OG001', 'title': 'Arms 1 and 2: Treatment B: High-Fat Meal, Tablet Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment B: high-fat meal, tablet formulation on Day 1 \\[Week 2\\] in Arm 1 and Day 1 \\[Week 1\\] in Arm 2).'}, {'id': 'OG002', 'title': 'Arms 1 and 2: Treatment C: Low-Fat Meal, Tablet Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment C: low-fat meal, tablet formulation on Day 1 \\[Week 3\\] in Arm 1 and Day 1 \\[Week 4\\] in Arm 2).'}, {'id': 'OG003', 'title': 'Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \\[Week 4\\] in Arm 1 and Day 1 \\[Week 3\\] in Arm 2).'}, {'id': 'OG004', 'title': 'Arms 4, 5, and 6: Treatment A: First Generation Tablet', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\\^2 orally in randomized treatment sequence (i.e. Treatment A: current \\[1st generation\\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).'}, {'id': 'OG005', 'title': 'Arms 4, 5, and 6: Treatment B: Second Generation Tablet', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\\^2 orally in randomized treatment sequence (i.e. Treatment B: new \\[2nd generation\\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).'}, {'id': 'OG006', 'title': 'Arms 4, 5, and 6: Treatment C: Oral Suspension', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '6.1'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '8.0'}, {'value': '3.4', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '6.1'}, {'value': '3.8', 'groupId': 'OG003', 'lowerLimit': '1.5', 'upperLimit': '5.0'}, {'value': '2.1', 'groupId': 'OG004', 'lowerLimit': '0.6', 'upperLimit': '5.1'}, {'value': '3.0', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '4.2'}, {'value': '1.6', 'groupId': 'OG006', 'lowerLimit': '1.0', 'upperLimit': '9.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose', '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 population included all participants in Arms 1, 2 and Arms 4, 5, and 6 who received selinexor, and for whom the PK profile for all treatments could be adequately characterized. Here 'overall number of participants analyzed' signifies participants who are evaluable for this outcome measure. As pre-specified in SAP and protocol Arm 3 was a non-PK group assessment, so data was not collected and analyzed for this PK outcome."}, {'type': 'PRIMARY', 'title': 'Terminal Phase Half-Life (t1/2) of Selinexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arms 1 and 2: Treatment A: Fasted, Tablet Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. (i.e. Treatment A: fasted, tablet formulation on Day 1 \\[Week 1\\] in Arm 1 and Day 1 \\[Week 2\\] in Arm 2).'}, {'id': 'OG001', 'title': 'Arms 1 and 2: Treatment B: High-Fat Meal, Tablet Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment B: high-fat meal, tablet formulation on Day 1 \\[Week 2\\] in Arm 1 and Day 1 \\[Week 1\\] in Arm 2).'}, {'id': 'OG002', 'title': 'Arms 1 and 2: Treatment C: Low-Fat Meal, Tablet Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment C: low-fat meal, tablet formulation on Day 1 \\[Week 3\\] in Arm 1 and Day 1 \\[Week 4\\] in Arm 2).'}, {'id': 'OG003', 'title': 'Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \\[Week 4\\] in Arm 1 and Day 1 \\[Week 3\\] in Arm 2).'}, {'id': 'OG004', 'title': 'Arms 4, 5, and 6: Treatment A: First Generation Tablet', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in randomized treatment sequence (i.e. Treatment A: current \\[1st generation\\] tablets on Day 1 and 3 \\[Week 1 and 3\\] in Arm 4 and 6 and Day 1 \\[Week 2\\] in Arm 2 for one cycle (Weeks 1 to 3).'}, {'id': 'OG005', 'title': 'Arms 4, 5, and 6: Treatment B: Second Generation Tablet', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\\^2 orally in randomized treatment sequence (i.e. Treatment B: new \\[2nd generation\\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).'}, {'id': 'OG006', 'title': 'Arms 4, 5, and 6: Treatment C: Oral Suspension', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '1.36', 'groupId': 'OG001'}, {'value': '5.6', 'spread': '1.00', 'groupId': 'OG002'}, {'value': '5.7', 'spread': '1.06', 'groupId': 'OG003'}, {'value': '6.7', 'spread': '1.34', 'groupId': 'OG004'}, {'value': '6.6', 'spread': '1.14', 'groupId': 'OG005'}, {'value': '6.5', 'spread': '1.51', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose', 'description': 't1/2 was the terminal phase half-life, it was calculated as ln(2)/kel.', 'unitOfMeasure': 'Hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population included all participants in Arms 1, 2 and Arms 4, 5, and 6 who received selinexor, and for whom the PK profile for all treatments could be adequately characterized. Here 'overall number of participants analyzed' signifies participants who are evaluable for this outcome measure. As pre-specified in SAP and protocol Arm 3 was a non-PK group assessment, so data was not collected and analyzed for this PK outcome."}, {'type': 'PRIMARY', 'title': 'Apparent Total Body Clearance (CL/F) of Selinexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arms 1 and 2: Treatment A: Fasted, Tablet Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \\[Week 1\\] in Arm 1 and Day 1 \\[Week 2\\] in Arm 2).'}, {'id': 'OG001', 'title': 'Arms 1 and 2: Treatment B: High-Fat Meal, Tablet Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment B: high-fat meal, tablet formulation on Day 1 \\[Week 2\\] in Arm 1 and Day 1 \\[Week 1\\] in Arm 2).'}, {'id': 'OG002', 'title': 'Arms 1 and 2: Treatment C: Low-Fat Meal, Tablet Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment C: low-fat meal, tablet formulation on Day 1 \\[Week 3\\] in Arm 1 and Day 1 \\[Week 4\\] in Arm 2).'}, {'id': 'OG003', 'title': 'Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \\[Week 4\\] in Arm 1 and Day 1 \\[Week 3\\] in Arm 2).'}, {'id': 'OG004', 'title': 'Arms 4, 5, and 6: Treatment A: First Generation Tablet', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\\^2 orally in randomized treatment sequence (i.e. Treatment A: current \\[1st generation\\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).'}, {'id': 'OG005', 'title': 'Arms 4, 5, and 6: Treatment B: Second Generation Tablet', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\\^2 orally in randomized treatment sequence (i.e. Treatment B: new \\[2nd generation\\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).'}, {'id': 'OG006', 'title': 'Arms 4, 5, and 6: Treatment C: Oral Suspension', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '32.1', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '21.3', 'groupId': 'OG001'}, {'value': '0.22', 'spread': '16.3', 'groupId': 'OG002'}, {'value': '0.21', 'spread': '18.7', 'groupId': 'OG003'}, {'value': '0.21', 'spread': '20.6', 'groupId': 'OG004'}, {'value': '0.20', 'spread': '16.6', 'groupId': 'OG005'}, {'value': '0.21', 'spread': '14.2', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose', 'description': 'Apparent total body clearance was calculated as Dose/AUC0-inf, uncorrected for fraction absorbed; reported normalized by participant body weight (kilogram \\[kg\\]).', 'unitOfMeasure': 'Liter per hour per kilogram (L/h/kg)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population included all participants in Arms 1, 2 and Arms 4, 5, and 6 who received selinexor, and for whom the PK profile for all treatments could be adequately characterized. Here 'overall number of participants analyzed' signifies participants who are evaluable for this outcome measure. As pre-specified in SAP and protocol Arm 3 was a non-PK group assessment, so data was not collected and analyzed for this PK outcome."}, {'type': 'PRIMARY', 'title': 'Apparent Volume of Distribution (Vd/F) of Selinexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arms 1 and 2: Treatment A: Fasted, Tablet Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \\[Week 1\\] in Arm 1 and Day 1 \\[Week 2\\] in Arm 2).'}, {'id': 'OG001', 'title': 'Arms 1 and 2: Treatment B: High-Fat Meal, Tablet Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment B: high-fat meal, tablet formulation on Day 1 \\[Week 2\\] in Arm 1 and Day 1 \\[Week 1\\] in Arm 2).'}, {'id': 'OG002', 'title': 'Arms 1 and 2: Treatment C: Low-Fat Meal, Tablet Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment C: low-fat meal, tablet formulation on Day 1 \\[Week 3\\] in Arm 1 and Day 1 \\[Week 4\\] in Arm 2).'}, {'id': 'OG003', 'title': 'Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \\[Week 4\\] in Arm 1 and Day 1 \\[Week 3\\] in Arm 2).'}, {'id': 'OG004', 'title': 'Arms 4, 5, and 6: Treatment A: First Generation Tablet', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\\^2 orally in randomized treatment sequence (i.e. Treatment A: current \\[1st generation\\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).'}, {'id': 'OG005', 'title': 'Arms 4, 5, and 6: Treatment B: Second Generation Tablet', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\\^2 orally in randomized treatment sequence (i.e. Treatment B: new \\[2nd generation\\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).'}, {'id': 'OG006', 'title': 'Arms 4, 5, and 6: Treatment C: Oral Suspension', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '49.5', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '32.3', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '26.1', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '26.6', 'groupId': 'OG003'}, {'value': '2.0', 'spread': '16.9', 'groupId': 'OG004'}, {'value': '1.9', 'spread': '18.3', 'groupId': 'OG005'}, {'value': '1.9', 'spread': '18.2', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose', 'description': 'Vd/F was calculated as Dose/ (kel \\*AUC0-inf), uncorrected for fraction absorbed; reported normalized by participant body weight (kg).', 'unitOfMeasure': 'Liter per kilogram (L/kg)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population included all participants in Arms 1, 2 and Arms 4, 5, and 6 who received selinexor, and for whom the PK profile for all treatments could be adequately characterized. Here 'overall number of participants analyzed' signifies participants who are evaluable for this outcome measure. As pre-specified in SAP and protocol Arm 3 was a non-PK group assessment, so data was not collected and analyzed for this PK outcome."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Best Overall Response According to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposarcoma', 'description': 'Participants with liposarcoma received selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (A, B, C, D) in Arm 1 and 2 for one cycle (Weeks 1 to 4); 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 in Arm 3; 60 mg/m\\^2 orally in randomized treatment sequence (A, B, C) on Day 1 and 3 for 1st generation tablets and Day 1 for 2nd generation tablets for one cycle (Weeks 1 to 3).'}, {'id': 'OG001', 'title': 'Leiomyosarcoma', 'description': 'Participants with leiomyosarcoma received selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (A, B, C, D) in Arm 1 and 2 for one cycle (Weeks 1 to 4); 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 in Arm 3; 60 mg/m\\^2 orally in randomized treatment sequence (A, B, C) on Day 1 and 3 for 1st generation tablets and Day 1 for 2nd generation tablets for one cycle (Weeks 1 to 3).'}, {'id': 'OG002', 'title': 'Other Sarcoma', 'description': 'Participants with Other sarcoma received selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (A, B, C, D) in Arm 1 and 2 for one cycle (Weeks 1 to 4); 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 in Arm 3; 60 mg/m\\^2 orally in randomized treatment sequence (A, B, C) on Day 1 and 3 for 1st generation tablets and Day 1 for 2nd generation tablets for one cycle (Weeks 1 to 3).'}], 'classes': [{'title': 'Complete Response (CR)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Partial Response (PR)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of first documented response until the date of documented progression or last disease assessment (up to 39 months)', 'description': 'Best overall response rate was defined as the percentage of participants who achieved complete response (CR), and partial response (PR), as assessed by the RECIST v1.1 criteria. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non target) must have reduction in the short axis to less than (\\<) 10 millimeter (mm). PR was defined as At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameter (LD).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all participants who received at least one dose of selinexor. Data for this outcome measure analysis was planned to be analyzed as per disease specific sarcoma.'}, {'type': 'SECONDARY', 'title': 'Duration of Stable Disease as Per RECIST v1.1 Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposarcoma', 'description': 'Participants with liposarcoma received selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (A, B, C, D) in Arm 1 and 2 for one cycle (Weeks 1 to 4); 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 in Arm 3; 60 mg/m\\^2 orally in randomized treatment sequence (A, B, C) on Day 1 and 3 for 1st generation tablets and Day 1 for 2nd generation tablets for one cycle (Weeks 1 to 3).'}, {'id': 'OG001', 'title': 'Leiomyosarcoma', 'description': 'Participants with leiomyosarcoma received selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (A, B, C, D) in Arm 1 and 2 for one cycle (Weeks 1 to 4); 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 in Arm 3; 60 mg/m\\^2 orally in randomized treatment sequence (A, B, C) on Day 1 and 3 for 1st generation tablets and Day 1 for 2nd generation tablets for one cycle (Weeks 1 to 3).'}, {'id': 'OG002', 'title': 'Other Sarcoma', 'description': 'Participants with Other sarcoma received selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (A, B, C, D) in Arm 1 and 2 for one cycle (Weeks 1 to 4); 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 in Arm 3; 60 mg/m\\^2 orally in randomized treatment sequence (A, B, C) on Day 1 and 3 for 1st generation tablets and Day 1 for 2nd generation tablets for one cycle (Weeks 1 to 3).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.49', 'comment': 'Data could not be estimated due to higher number (\\>50%) of censored participants.', 'groupId': 'OG000', 'lowerLimit': '3.55', 'upperLimit': 'NA'}, {'value': '3.94', 'groupId': 'OG001', 'lowerLimit': '1.64', 'upperLimit': '5.55'}, {'value': '8.34', 'comment': 'Data could not be estimated due to higher number (\\>50%) of censored participants.', 'groupId': 'OG002', 'lowerLimit': '3.09', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first dose of study treatment to first documented radiologic evidence of disease recurrence or progression, censored date (up to 39 months)', 'description': 'Duration of at least stable disease was defined as the time from the date of first dose of study treatment to first documented radiologic evidence of disease recurrence or progression as per RECIST v1.1 Criteria. Participants without evidence of progression were censored at time of last disease assessment. Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded since the treatment started. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions also constituted progressive disease.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all participants who received at least one dose of selinexor. Data for this outcome measure was planned to be analyzed as per disease specific sarcoma.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) as Per RECIST v1.1 Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposarcoma', 'description': 'Participants with liposarcoma received selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (A, B, C, D) in Arm 1 and 2 for one cycle (Weeks 1 to 4); 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 in Arm 3; 60 mg/m\\^2 orally in randomized treatment sequence (A, B, C) on Day 1 and 3 for 1st generation tablets and Day 1 for 2nd generation tablets for one cycle (Weeks 1 to 3).'}, {'id': 'OG001', 'title': 'Leiomyosarcoma', 'description': 'Participants with leiomyosarcoma received selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (A, B, C, D) in Arm 1 and 2 for one cycle (Weeks 1 to 4); 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 in Arm 3; 60 mg/m\\^2 orally in randomized treatment sequence (A, B, C) on Day 1 and 3 for 1st generation tablets and Day 1 for 2nd generation tablets for one cycle (Weeks 1 to 3).'}, {'id': 'OG002', 'title': 'Other Sarcoma', 'description': 'Participants with Other sarcoma received selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (A, B, C, D) in Arm 1 and 2 for one cycle (Weeks 1 to 4); 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 in Arm 3; 60 mg/m\\^2 orally in randomized treatment sequence (A, B, C) on Day 1 and 3 for 1st generation tablets and Day 1 for 2nd generation tablets for one cycle (Weeks 1 to 3).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.44', 'groupId': 'OG000', 'lowerLimit': '2.07', 'upperLimit': '7.49'}, {'value': '3.52', 'groupId': 'OG001', 'lowerLimit': '1.48', 'upperLimit': '5.55'}, {'value': '1.84', 'groupId': 'OG002', 'lowerLimit': '1.02', 'upperLimit': '3.58'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study treatment to time of disease progression or death, censored date (up to 39 months)', 'description': 'PFS was defined as the time from the date of randomization until the first date of Independent Review Committee (IRC)-confirmed PD per RECIST v1.1, or death due to any cause. PD was defined as at least a 20% increase in the sum of the longest diameter (SLD), taking as reference the smallest sum of the longest diameter (SLD) recorded from baseline or the appearance of 1 or more new lesions. Participants who were last known to be alive and without evidence of progression were censored at time of last disease assessment. If date of progression or death occurred after more than 1 missed disease assessment interval, or 30 days after end of treatment, participants were censored at the time of last evaluable disease assessment prior to the missed assessment.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all participants who received at least one dose of selinexor. Data for this outcome measure was planned to be analyzed as per disease specific sarcoma.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposarcoma', 'description': 'Participants with liposarcoma received selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (A, B, C, D) in Arm 1 and 2 for one cycle (Weeks 1 to 4); 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 in Arm 3; 60 mg/m\\^2 orally in randomized treatment sequence (A, B, C) on Day 1 and 3 for 1st generation tablets and Day 1 for 2nd generation tablets for one cycle (Weeks 1 to 3).'}, {'id': 'OG001', 'title': 'Leiomyosarcoma', 'description': 'Participants with leiomyosarcoma received selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (A, B, C, D) in Arm 1 and 2 for one cycle (Weeks 1 to 4); 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 in Arm 3; 60 mg/m\\^2 orally in randomized treatment sequence (A, B, C) on Day 1 and 3 for 1st generation tablets and Day 1 for 2nd generation tablets for one cycle (Weeks 1 to 3).'}, {'id': 'OG002', 'title': 'Other Sarcoma', 'description': 'Participants with Other sarcoma received selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (A, B, C, D) in Arm 1 and 2 for one cycle (Weeks 1 to 4); 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 in Arm 3; 60 mg/m\\^2 orally in randomized treatment sequence (A, B, C) on Day 1 and 3 for 1st generation tablets and Day 1 for 2nd generation tablets for one cycle (Weeks 1 to 3).'}], 'classes': [{'categories': [{'measurements': [{'value': '9.00', 'comment': 'Data could not be estimated due to higher number (\\>50%) of censored participants.', 'groupId': 'OG000', 'lowerLimit': '4.76', 'upperLimit': 'NA'}, {'value': '7.03', 'comment': 'Data could not be estimated due to higher number (\\>50%) of censored participants.', 'groupId': 'OG001', 'lowerLimit': '5.75', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data could not be estimated due to higher number (\\>50%) of censored participants.', 'groupId': 'OG002', 'lowerLimit': '3.38', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study treatment to death, censored date (up to 39 months)', 'description': 'OS was defined as the time from date first dose of study treatment to the date of death. Participants who were still alive prior to the data cutoff for final efficacy analysis, or who dropped out prior to study end, were censored at the day they were last known to be alive.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all participants who received at least one dose of selinexor. Data for this outcome measure was planned to be analyzed as per disease specific sarcoma.'}, {'type': 'SECONDARY', 'title': 'Time to Progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposarcoma', 'description': 'Participants with liposarcoma received selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (A, B, C, D) in Arm 1 and 2 for one cycle (Weeks 1 to 4); 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 in Arm 3; 60 mg/m\\^2 orally in randomized treatment sequence (A, B, C) on Day 1 and 3 for 1st generation tablets and Day 1 for 2nd generation tablets for one cycle (Weeks 1 to 3).'}, {'id': 'OG001', 'title': 'Leiomyosarcoma', 'description': 'Participants with leiomyosarcoma received selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (A, B, C, D) in Arm 1 and 2 for one cycle (Weeks 1 to 4); 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 in Arm 3; 60 mg/m\\^2 orally in randomized treatment sequence (A, B, C) on Day 1 and 3 for 1st generation tablets and Day 1 for 2nd generation tablets for one cycle (Weeks 1 to 3).'}, {'id': 'OG002', 'title': 'Other Sarcoma', 'description': 'Participants with Other sarcoma received selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (A, B, C, D) in Arm 1 and 2 for one cycle (Weeks 1 to 4); 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 in Arm 3; 60 mg/m\\^2 orally in randomized treatment sequence (A, B, C) on Day 1 and 3 for 1st generation tablets and Day 1 for 2nd generation tablets for one cycle (Weeks 1 to 3).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.44', 'comment': 'Data could not be estimated due to higher number (\\>50%) of censored participants.', 'groupId': 'OG000', 'lowerLimit': '2.07', 'upperLimit': 'NA'}, {'value': '3.52', 'groupId': 'OG001', 'lowerLimit': '1.48', 'upperLimit': '5.55'}, {'value': '1.74', 'groupId': 'OG002', 'lowerLimit': '1.02', 'upperLimit': '5.55'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study treatment to first documented evidence of disease recurrence or progression, or death, censored date (up to 39 months)', 'description': 'TTP was defined as the time from date of first dose of study treatment to first documented evidence of disease recurrence or progression, or death due to disease progression, whichever occurred first. Participants without evidence of progression were censored at time of last evaluable disease assessment.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all participants who received at least one dose of selinexor. Data for this outcome measure was planned to be analyzed as per disease specific sarcoma.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Growth Modulation Index (GMI) Less Than or Equal to (<=) 1.33 and Greater Than (>) 1.33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposarcoma', 'description': 'Participants with liposarcoma received selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (A, B, C, D) in Arm 1 and 2 for one cycle (Weeks 1 to 4); 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 in Arm 3; 60 mg/m\\^2 orally in randomized treatment sequence (A, B, C) on Day 1 and 3 for 1st generation tablets and Day 1 for 2nd generation tablets for one cycle (Weeks 1 to 3).'}, {'id': 'OG001', 'title': 'Leiomyosarcoma', 'description': 'Participants with leiomyosarcoma received selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (A, B, C, D) in Arm 1 and 2 for one cycle (Weeks 1 to 4); 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 in Arm 3; 60 mg/m\\^2 orally in randomized treatment sequence (A, B, C) on Day 1 and 3 for 1st generation tablets and Day 1 for 2nd generation tablets for one cycle (Weeks 1 to 3).'}, {'id': 'OG002', 'title': 'Other Sarcoma', 'description': 'Participants with Other sarcoma received selinexor 30 mg/m\\^2 orally twice weekly in randomized treatment sequence (A, B, C, D) in Arm 1 and 2 for one cycle (Weeks 1 to 4); 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 in Arm 3; 60 mg/m\\^2 orally in randomized treatment sequence (A, B, C) on Day 1 and 3 for 1st generation tablets and Day 1 for 2nd generation tablets for one cycle (Weeks 1 to 3).'}], 'classes': [{'title': 'GMI <= 1.33', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'GMI > 1.33', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 39 months', 'description': 'GMI was defined as the ratio between the TTP with selinexor and the TTP with the most recent prior treatment. GMI was calculated, using a previously described threshold of 1.3 or greater as a sign of potential drug activity and improved overall survival.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population consisted of all participants who received at least one dose of selinexor. Data for this outcome measure was planned to be analyzed as per disease specific sarcoma. Here 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 milligrams per meter square (mg/m\\^2) orally twice weekly in treatment sequence ABCD (Treatment A: fasted, tablet formulation on Day 1 of Week 1; Treatment B: high-fat meal, tablet formulation on Day 1 of Week 2; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 3; Treatment D: low-fat meal, capsule formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).'}, {'id': 'OG001', 'title': 'Arm 2:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: lowfat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).'}, {'id': 'OG002', 'title': 'Arm 3:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.'}, {'id': 'OG003', 'title': 'Arm 4:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in treatment sequence ABC (Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 1; Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 2; Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.'}, {'id': 'OG004', 'title': 'Arm 5:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in treatment sequence CAB (Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 1; Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 2; Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.'}, {'id': 'OG005', 'title': 'Arm 6:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in treatment sequence BCA (Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 1; Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 2; Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.'}], 'classes': [{'title': 'Participants with TEAEs', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}, {'title': 'Participants with Serious TEAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From screening up to 30 days post last study drug dose (up to 39 months)', 'description': 'An AE was any untoward medical occurrence in a 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. SAE defined as any AE, occurring at any dose (including after the informed consent form was signed and prior to dosing) that and regardless of causality that: results in death, is life-threatening (participant was at immediate risk of death from event as it occurred), requires in-patient hospitalization (formal admission to a hospital for medical reasons) or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect. TEAE was defined as any AE with onset or worsening of a pre-existing condition on or after the first administration of study treatment through 30 days following last dose or any event considered drug-related by the investigator through the end of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 milligrams per meter square (mg/m\\^2) orally twice weekly in treatment sequence ABCD (Treatment A: fasted, tablet formulation on Day 1 of Week 1; Treatment B: high-fat meal, tablet formulation on Day 1 of Week 2; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 3; Treatment D: low-fat meal, capsule formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).'}, {'id': 'OG001', 'title': 'Arm 2:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).'}, {'id': 'OG002', 'title': 'Arm 3:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.'}, {'id': 'OG003', 'title': 'Arm 4:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in treatment sequence ABC (Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 1; Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 2; Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.'}, {'id': 'OG004', 'title': 'Arm 5:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in treatment sequence CAB (Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 1; Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 2; Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.'}, {'id': 'OG005', 'title': 'Arm 6:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in treatment sequence BCA (Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 1; Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 2; Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.'}], 'classes': [{'categories': [{'title': 'Grade 1: Mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'Grade 2: Moderate', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': 'Grade 3: Severe', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'Grade 4: Life Threatening', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': 'Grade 5: Fatal', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From screening up to 30 days post last study drug dose (up to 39 months)', 'description': "AE was defined as the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition that occur after participant's signed informed consent obtained. TEAE was defined as any AE with onset or worsening of a pre-existing condition on or after the first administration of study treatment through 28 days following last dose or any event considered drug-related by the investigator through the end of the study. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 milligrams per meter square (mg/m\\^2) orally twice weekly in treatment sequence ABCD (Treatment A: fasted, tablet formulation on Day 1 of Week 1; Treatment B: high-fat meal, tablet formulation on Day 1 of Week 2; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 3; Treatment D: low-fat meal, capsule formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).'}, {'id': 'OG001', 'title': 'Arm 2:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).'}, {'id': 'OG002', 'title': 'Arm 3:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and other sarcoma) received selinexor 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.'}, {'id': 'OG003', 'title': 'Arm 4:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in treatment sequence ABC (Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 1; Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 2; Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.'}, {'id': 'OG004', 'title': 'Arm 5:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in treatment sequence CAB (Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 1; Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 2; Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.'}, {'id': 'OG005', 'title': 'Arm 6:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in treatment sequence BCA (Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 1; Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 2; Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.'}], 'classes': [{'title': 'Hematology', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Clinical Chemistry', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Coagulation: Prothrombin intl. normalized ratio', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Urinalysis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From screening up to 30 days post last study drug dose (up to 39 months)', 'description': 'Number of participants with clinically significant laboratory abnormalities including clinical chemistry, hematology, coagulation and urinalysis. Number of participants with clinically significant laboratory abnormalities which were deemed clinically significant by the investigator were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Changes in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 milligrams per meter square (mg/m\\^2) orally twice weekly in treatment sequence ABCD (Treatment A: fasted, tablet formulation on Day 1 of Week 1; Treatment B: high-fat meal, tablet formulation on Day 1 of Week 2; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 3; Treatment D: low-fat meal, capsule formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).'}, {'id': 'OG001', 'title': 'Arm 2:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).'}, {'id': 'OG002', 'title': 'Arm 3:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.'}, {'id': 'OG003', 'title': 'Arm 4:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in treatment sequence ABC (Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 1; Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 2; Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.'}, {'id': 'OG004', 'title': 'Arm 5:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in treatment sequence CAB (Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 1; Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 2; Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.'}, {'id': 'OG005', 'title': 'Arm 6:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in treatment sequence BCA (Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 1; Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 2; Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.'}], 'classes': [{'title': 'Systolic Blood Pressure: < 100 mmHg (Yes)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Systolic Blood Pressure: > 10 mmHg decrease from baseline (Yes)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}, {'title': 'Systolic Blood Pressure: > 20 mmHg decrease from baseline (Yes)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Systolic Blood Pressure: < 100 mmHg and > 10 mmHg decrease from baseline (Yes)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Systolic Blood Pressure: < 100 mmHg and > 20 mmHg decrease from baseline (Yes)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Diastolic Blood Pressure: < 60 mmHg (Yes)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Diastolic Blood Pressure: > 5 mmHg decrease from baseline (Yes)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}, {'title': 'Diastolic Blood Pressure: > 10 mmHg decrease from baseline (Yes)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Diastolic Blood Pressure: < 60 mmHg and > 5 mmHg decrease from baseline (Yes)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Diastolic Blood Pressure: < 60 mmHg and > 10 mmHg decrease from baseline (Yes)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Systolic Blood Pressure : > 140 mmHg (Yes)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Systolic Blood Pressure: > 160 mmHg (Yes)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Systolic Blood Pressure: > 10 mmHg increase from baseline (Yes)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}, {'title': 'Systolic Blood Pressure: > 20 mmHg increase from baseline (Yes)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Systolic Blood Pressure: > 160 mmHg and > 10 mmHg increase from baseline (Yes)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Systolic Blood Pressure: > 160 mmHg and > 20 mmHg increase from baseline (Yes)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Diastolic Blood Pressure: > 90 mmHg (Yes)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Diastolic Blood Pressure: > 100 mmHg (Yes)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Diastolic Blood Pressure: > 5 mmHg increase from baseline (Yes)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}, {'title': 'Diastolic Blood Pressure: > 10 mmHg increase from baseline (Yes)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Diastolic Blood Pressure: > 100 mmHg and > 5 mmHg increase from baseline (Yes)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Diastolic Blood Pressure: > 100 mmHg and > 10 mmHg increase from baseline (Yes)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From screening up to 30 days post last study drug dose (up to 39 months)', 'description': 'Vital signs included blood pressure (systolic blood pressure and diastolic blood pressure). Measurements were made after the participant had been resting supine for a minimum of 5 minutes. Clinically significant findings were defined as such in the opinion of the investigator occurring at any time on treatment from normal pre-dose based on the condition met (Yes/No). Number of participants with clinically significant changes in vital signs with condition (Yes) were only reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 milligrams per meter square (mg/m\\^2) orally twice weekly in treatment sequence ABCD (Treatment A: fasted, tablet formulation on Day 1 of Week 1; Treatment B: high-fat meal, tablet formulation on Day 1 of Week 2; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 3; Treatment D: low-fat meal, capsule formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).'}, {'id': 'OG001', 'title': 'Arm 2:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).'}, {'id': 'OG002', 'title': 'Arm 3:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.'}, {'id': 'OG003', 'title': 'Arm 4:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\\^2 orally in treatment sequence ABC (Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 1; Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 2; Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.'}, {'id': 'OG004', 'title': 'Arm 5:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\\^2 orally in treatment sequence CAB (Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 1; Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 2; Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.'}, {'id': 'OG005', 'title': 'Arm 6:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\\^2 orally in treatment sequence BCA (Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 1; Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 2; Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From screening up to 30 days post last study drug dose', 'description': 'Twelve lead ECGs were obtained after the participant has rested in a supine position for at least 5 minutes. Clinically significant findings were defined as such in the opinion of the investigator or designated physician occurring at any time on treatment from normal pre-dose.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 milligrams per meter square (mg/m\\^2) orally twice weekly in treatment sequence ABCD (Treatment A: fasted, tablet formulation on Day 1 of Week 1; Treatment B: high-fat meal, tablet formulation on Day 1 of Week 2; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 3; Treatment D: low-fat meal, capsule formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).'}, {'id': 'FG001', 'title': 'Arm 2:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low-fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).'}, {'id': 'FG002', 'title': 'Arm 3:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.'}, {'id': 'FG003', 'title': 'Arm 4:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in treatment sequence ABC (Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 1; Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 2; Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.'}, {'id': 'FG004', 'title': 'Arm 5:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in treatment sequence CAB (Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 1; Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 2; Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.'}, {'id': 'FG005', 'title': 'Arm 6:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in treatment sequence BCA (Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 1; Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 2; Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'Need of treatment not allowed per protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Intercurrent illness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted at 2 sites in United States and Canada from 30 July 2013 to 21 October 2016.', 'preAssignmentDetails': 'A total of 54 participants were enrolled and randomized to study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '54', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\\^2 orally twice weekly in treatment sequence ABCD (Treatment A: fasted, tablet formulation on Day 1 of Week 1; Treatment B: high-fat meal, tablet formulation on Day 1 of Week 2; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 3; Treatment D: low-fat meal, capsule formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).'}, {'id': 'BG001', 'title': 'Arm 2:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low-fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).'}, {'id': 'BG002', 'title': 'Arm 3:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.'}, {'id': 'BG003', 'title': 'Arm 4:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in treatment sequence ABC (Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 1; Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 2; Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.'}, {'id': 'BG004', 'title': 'Arm 5:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in treatment sequence CAB (Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 1; Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 2; Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.'}, {'id': 'BG005', 'title': 'Arm 6:', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\\^2 orally in treatment sequence BCA (Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 1; Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 2; Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.7', 'spread': '12.72', 'groupId': 'BG000'}, {'value': '57.6', 'spread': '17.18', 'groupId': 'BG001'}, {'value': '59.9', 'spread': '13.90', 'groupId': 'BG002'}, {'value': '53.4', 'spread': '8.10', 'groupId': 'BG003'}, {'value': '43.6', 'spread': '19.32', 'groupId': 'BG004'}, {'value': '53.8', 'spread': '11.62', 'groupId': 'BG005'}, {'value': '55.0', 'spread': '14.22', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '31', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '49', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', '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'}, {'value': '0', 'groupId': 'BG006'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}]}, {'title': 'Native Hawaiian or Other 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'}, {'value': '0', 'groupId': 'BG006'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population consisted of all participants who received at least one dose of selinexor.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2016-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-20', 'studyFirstSubmitDate': '2013-06-11', 'resultsFirstSubmitDate': '2022-05-17', 'studyFirstSubmitQcDate': '2013-07-10', 'lastUpdatePostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-20', 'studyFirstPostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve From the Time Zero to the Last Non-zero Concentration (AUC0-t) of Selinexor', 'timeFrame': 'Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10,18, 24, and 48 hours post-dose', '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 the Time Zero to Extrapolated to Infinity (AUC0-inf) of Selinexor', 'timeFrame': 'Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose', 'description': 'AUC0-inf was defined as area under the concentration-time curve from time zero to infinity (extrapolated), AUC0-inf was calculated as AUC0-t + Ct/ elimination rate constant (kel), where: Ct = the last observed non- zero concentration.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Selinexor', 'timeFrame': 'Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose', 'description': 'Cmax was defined as maximum observed concentration, taken directly from the plasma concentration data.'}, {'measure': 'Time of First Maximum Observed Concentration (Tmax) of Selinexor', 'timeFrame': 'Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose', 'description': 'Tmax was defined as time of first observation of Cmax, taken directly from the plasma concentration data.'}, {'measure': 'Terminal Phase Half-Life (t1/2) of Selinexor', 'timeFrame': 'Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose', 'description': 't1/2 was the terminal phase half-life, it was calculated as ln(2)/kel.'}, {'measure': 'Apparent Total Body Clearance (CL/F) of Selinexor', 'timeFrame': 'Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose', 'description': 'Apparent total body clearance was calculated as Dose/AUC0-inf, uncorrected for fraction absorbed; reported normalized by participant body weight (kilogram \\[kg\\]).'}, {'measure': 'Apparent Volume of Distribution (Vd/F) of Selinexor', 'timeFrame': 'Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose', 'description': 'Vd/F was calculated as Dose/ (kel \\*AUC0-inf), uncorrected for fraction absorbed; reported normalized by participant body weight (kg).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Best Overall Response According to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Criteria', 'timeFrame': 'From the date of first documented response until the date of documented progression or last disease assessment (up to 39 months)', 'description': 'Best overall response rate was defined as the percentage of participants who achieved complete response (CR), and partial response (PR), as assessed by the RECIST v1.1 criteria. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non target) must have reduction in the short axis to less than (\\<) 10 millimeter (mm). PR was defined as At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameter (LD).'}, {'measure': 'Duration of Stable Disease as Per RECIST v1.1 Criteria', 'timeFrame': 'From the date of first dose of study treatment to first documented radiologic evidence of disease recurrence or progression, censored date (up to 39 months)', 'description': 'Duration of at least stable disease was defined as the time from the date of first dose of study treatment to first documented radiologic evidence of disease recurrence or progression as per RECIST v1.1 Criteria. Participants without evidence of progression were censored at time of last disease assessment. Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded since the treatment started. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions also constituted progressive disease.'}, {'measure': 'Progression Free Survival (PFS) as Per RECIST v1.1 Criteria', 'timeFrame': 'From first dose of study treatment to time of disease progression or death, censored date (up to 39 months)', 'description': 'PFS was defined as the time from the date of randomization until the first date of Independent Review Committee (IRC)-confirmed PD per RECIST v1.1, or death due to any cause. PD was defined as at least a 20% increase in the sum of the longest diameter (SLD), taking as reference the smallest sum of the longest diameter (SLD) recorded from baseline or the appearance of 1 or more new lesions. Participants who were last known to be alive and without evidence of progression were censored at time of last disease assessment. If date of progression or death occurred after more than 1 missed disease assessment interval, or 30 days after end of treatment, participants were censored at the time of last evaluable disease assessment prior to the missed assessment.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From first dose of study treatment to death, censored date (up to 39 months)', 'description': 'OS was defined as the time from date first dose of study treatment to the date of death. Participants who were still alive prior to the data cutoff for final efficacy analysis, or who dropped out prior to study end, were censored at the day they were last known to be alive.'}, {'measure': 'Time to Progression (TTP)', 'timeFrame': 'From first dose of study treatment to first documented evidence of disease recurrence or progression, or death, censored date (up to 39 months)', 'description': 'TTP was defined as the time from date of first dose of study treatment to first documented evidence of disease recurrence or progression, or death due to disease progression, whichever occurred first. Participants without evidence of progression were censored at time of last evaluable disease assessment.'}, {'measure': 'Number of Participants With Growth Modulation Index (GMI) Less Than or Equal to (<=) 1.33 and Greater Than (>) 1.33', 'timeFrame': 'Up to 39 months', 'description': 'GMI was defined as the ratio between the TTP with selinexor and the TTP with the most recent prior treatment. GMI was calculated, using a previously described threshold of 1.3 or greater as a sign of potential drug activity and improved overall survival.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs', 'timeFrame': 'From screening up to 30 days post last study drug dose (up to 39 months)', 'description': 'An AE was any untoward medical occurrence in a 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. SAE defined as any AE, occurring at any dose (including after the informed consent form was signed and prior to dosing) that and regardless of causality that: results in death, is life-threatening (participant was at immediate risk of death from event as it occurred), requires in-patient hospitalization (formal admission to a hospital for medical reasons) or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect. TEAE was defined as any AE with onset or worsening of a pre-existing condition on or after the first administration of study treatment through 30 days following last dose or any event considered drug-related by the investigator through the end of the study.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity', 'timeFrame': 'From screening up to 30 days post last study drug dose (up to 39 months)', 'description': "AE was defined as the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition that occur after participant's signed informed consent obtained. TEAE was defined as any AE with onset or worsening of a pre-existing condition on or after the first administration of study treatment through 28 days following last dose or any event considered drug-related by the investigator through the end of the study. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death."}, {'measure': 'Number of Participants With Clinically Significant Laboratory Abnormalities', 'timeFrame': 'From screening up to 30 days post last study drug dose (up to 39 months)', 'description': 'Number of participants with clinically significant laboratory abnormalities including clinical chemistry, hematology, coagulation and urinalysis. Number of participants with clinically significant laboratory abnormalities which were deemed clinically significant by the investigator were reported.'}, {'measure': 'Number of Participants With Clinically Significant Changes in Vital Signs', 'timeFrame': 'From screening up to 30 days post last study drug dose (up to 39 months)', 'description': 'Vital signs included blood pressure (systolic blood pressure and diastolic blood pressure). Measurements were made after the participant had been resting supine for a minimum of 5 minutes. Clinically significant findings were defined as such in the opinion of the investigator occurring at any time on treatment from normal pre-dose based on the condition met (Yes/No). Number of participants with clinically significant changes in vital signs with condition (Yes) were only reported.'}, {'measure': 'Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs)', 'timeFrame': 'From screening up to 30 days post last study drug dose', 'description': 'Twelve lead ECGs were obtained after the participant has rested in a supine position for at least 5 minutes. Clinically significant findings were defined as such in the opinion of the investigator or designated physician occurring at any time on treatment from normal pre-dose.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bone sarcoma', 'Soft-tissue sarcoma', 'Sarcoma', 'KPT-330', 'Food', 'Effects', 'Selinexor'], 'conditions': ['Sarcoma']}, 'referencesModule': {'references': [{'pmid': '27458288', 'type': 'DERIVED', 'citation': "Gounder MM, Zer A, Tap WD, Salah S, Dickson MA, Gupta AA, Keohan ML, Loong HH, D'Angelo SP, Baker S, Condy M, Nyquist-Schultz K, Tanner L, Erinjeri JP, Jasmine FH, Friedlander S, Carlson R, Unger TJ, Saint-Martin JR, Rashal T, Ellis J, Kauffman M, Shacham S, Schwartz GK, Abdul Razak AR. Phase IB Study of Selinexor, a First-in-Class Inhibitor of Nuclear Export, in Patients With Advanced Refractory Bone or Soft Tissue Sarcoma. J Clin Oncol. 2016 Sep 10;34(26):3166-74. doi: 10.1200/JCO.2016.67.6346. Epub 2016 Jul 25."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to find out more information such as: to determine the effects of high and low fat foods on the pharmacokinetics (PK) of oral KPT-330 tablets and to compare PK of capsules and tablets in Arms 1 and 2; to evaluate tumor response in sarcoma participants in Arm 3; to compare the PK of 60 milligrams (mg) of the new, 2nd generation tablet formulation and 60 mg of the selinexor suspension formula to the current, 1st generation tablets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must have histologically confirmed soft tissue or bone/cartilage sarcoma. Patients with sarcoma of small round blue cell tumor types are allowed. Gastrointestinal stromal tumors (GIST) are excluded.\n2. Patients must have received at least one prior anticancer regimen for metastatic disease unless there is no other therapy available and evidence of progressive disease on study entry. Patients with stable disease will be included if there has been failure to respond to another drug(s) within the previous 3 months\n\nExclusion Criteria:\n\n1. Patients with known liver metastases\n2. Radiation, chemotherapy, immunotherapy, any other systemic anticancer therapy or participation in an investigational anti-cancer study ≤ 3 weeks prior to initiation of therapy\n3. Patients with known brain metastasis\n4. Patients with any gastrointestinal dysfunctions that could interfere with the interpretation of the food effect data\n5. Patients with known intolerance to low or high fat meals\n6. In the opinion of the investigator, patients who are significantly below their ideal body weight'}, 'identificationModule': {'nctId': 'NCT01896505', 'briefTitle': 'A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Karyopharm Therapeutics Inc'}, 'officialTitle': 'An Open-Label Phase IB Trial To Evaluate the Effects of Food and Formulation on Pharmacokinetics of the Oral Selective Inhibitor of Nuclear Export/SINE Compound KPT-330 in Patients With Soft-Tissue or Bone Sarcoma', 'orgStudyIdInfo': {'id': 'KCP-330-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 milligrams per meter square (mg/m\\^2) orally twice weekly in treatment sequence ABCD (Treatment A: fasted, tablet formulation on Day 1 of Week 1; Treatment B: high-fat meal, tablet formulation on Day 1 of Week 2; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 3; Treatment D: low-fat meal, capsule formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).', 'interventionNames': ['Drug: KCP-330']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.', 'interventionNames': ['Drug: KCP-330']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 50 mg/m\\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.', 'interventionNames': ['Drug: KCP-330']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\\^2 orally in treatment sequence ABC (Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 1; Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 2; Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.', 'interventionNames': ['Drug: KCP-330']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 5', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\\^2 orally in treatment sequence CAB (Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 1; Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 2; Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.', 'interventionNames': ['Drug: KCP-330']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 6', 'description': 'Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\\^2 orally in treatment sequence BCA (Treatment B: new \\[2nd generation\\] tablets on Day 1 of Week 1; Treatment C: suspension dose of current \\[1st generation\\] tablets on Day 1 of Week 2; Treatment A: current \\[1st generation\\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.', 'interventionNames': ['Drug: KCP-330']}], 'interventions': [{'name': 'KCP-330', 'type': 'DRUG', 'otherNames': ['Selinexor'], 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3', 'Arm 4', 'Arm 5', 'Arm 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Centre', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': 'M5T 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Michael Kauffman, MD, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karyopharm Therapeutics Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karyopharm Therapeutics Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}