Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2026-02-25 @ 9:46 PM
Study NCT ID:
NCT02606461
Status:
COMPLETED
Last Update Posted:
2023-01-23
First Post:
2015-10-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Selinexor in Advanced Liposarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008080', 'term': 'Liposarcoma'}], 'ancestors': [{'id': 'D018205', 'term': 'Neoplasms, Adipose Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C585161', 'term': 'selinexor'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@karyopharm.com', 'phone': '(888) 209-9326', 'title': 'Karyopharm Medical Information', 'organization': 'Karyopharm Therapeutics Inc'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of study drug administration up to 70 months', 'description': 'The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 2 Double-blinded: Selinexor', 'description': 'Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 27, 'seriousNumAtRisk': 27, 'deathsNumAffected': 18, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Phase 2 Double-blinded: Placebo', 'description': 'Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 29, 'seriousNumAtRisk': 30, 'deathsNumAffected': 25, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Phase 3 Double-blinded: Selinexor', 'description': 'Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.', 'otherNumAtRisk': 187, 'deathsNumAtRisk': 187, 'otherNumAffected': 186, 'seriousNumAtRisk': 187, 'deathsNumAffected': 127, 'seriousNumAffected': 73}, {'id': 'EG003', 'title': 'Phase 3 Double-blinded: Placebo', 'description': 'Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 94, 'seriousNumAtRisk': 97, 'deathsNumAffected': 67, 'seriousNumAffected': 18}, {'id': 'EG004', 'title': 'Phase 2 Open-label: Selinexor', 'description': 'Participants in the placebo group who had PD during Phase 2 double-blinded treatment were entered in open-label and received selinexor 60 mg tablet twice-weekly during Weeks 1 to 6 of each 6-week (42-day) cycle.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'deathsNumAffected': 20, 'seriousNumAffected': 13}, {'id': 'EG005', 'title': 'Phase 3 Open-label: Selinexor', 'description': 'Participants in the placebo group who had PD during Phase 3 double-blinded treatment, were entered in open-label and received selinexor 60 mg tablet twice-weekly during Weeks 1 to 6 of each 6-week (42-day) cycle.', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 62, 'seriousNumAtRisk': 63, 'deathsNumAffected': 43, 'seriousNumAffected': 25}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 91}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 22}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 26}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 72}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sinus Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 42}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Visual Impairement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 151}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 38}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 20}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 45}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 93}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 49}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 30}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 74}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 23}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 75}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 96}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 31}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 58}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 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'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Retinal tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase 3 Double Blind: Progression-free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3 Double-blinded: Selinexor', 'description': 'Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}, {'id': 'OG001', 'title': 'Phase 3 Double-blinded: Placebo', 'description': 'Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.83', 'groupId': 'OG000', 'lowerLimit': '2.73', 'upperLimit': '4.11'}, {'value': '2.07', 'groupId': 'OG001', 'lowerLimit': '1.51', 'upperLimit': '3.06'}]}]}], 'analyses': [{'pValue': '0.0114', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7026', 'ciLowerLimit': '0.5191', 'ciUpperLimit': '0.9509', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization until the first date of disease progression, or death due to any cause whichever occurred first (up to 57 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 version 1.1, 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.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 3 Intent-to-Treat Population (Ph3-ITT) consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment.'}, {'type': 'PRIMARY', 'title': 'Phase 3 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3 Open Label: Selinexor', 'description': 'Participants in the placebo group who had PD during Phase 3 double-blinded treatment, were entered in open-label and received selinexor 60 mg tablet twice-weekly during Weeks 1 to 6 of each 6-week (42-day) cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.73', 'groupId': 'OG000', 'lowerLimit': '1.97', 'upperLimit': '4.14'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization in the Phase 3 open label period until the first date of disease progression, or death due to any cause whichever occurred first (up to 57 months)', 'description': 'PFS was defined as the time from the date of randomization in the Phase 3 open-label period until the first date of IRC-confirmed PD per RECIST version 1.1, or death due to any cause. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Phase 3 Open-Label Population (Ph3-OL) consisted of all participants in Phase 3 who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.'}, {'type': 'PRIMARY', 'title': 'Phase 2 Double Blind: Progression-free Survival (PFS) as Per RECIST Version 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 Double-blinded: Selinexor', 'description': 'Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}, {'id': 'OG001', 'title': 'Phase 2 Double-blinded: Placebo', 'description': 'Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.02', 'comment': 'Data could not be estimated due to higher number (\\>50%) of deaths.', 'groupId': 'OG000', 'lowerLimit': '1.41', 'upperLimit': 'NA'}, {'value': '2.76', 'comment': 'Data could not be estimated due to higher number (\\>50%) of deaths.', 'groupId': 'OG001', 'lowerLimit': '1.58', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.6051', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1521', 'ciLowerLimit': '0.5357', 'ciUpperLimit': '2.4778', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 57 months)', 'description': 'PFS was defined as the time from date of randomization until the first date of IRC-confirmed PD per RECIST version 1.1, or death due to any cause. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Phase 2 Intent-to-Treat Population (Ph2-ITT) consisted of all participants randomized to study treatment in Phase 2, regardless of whether or not they received study treatment.'}, {'type': 'PRIMARY', 'title': 'Phase 2 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 Open Label: Selinexor', 'description': 'Participants in the placebo group who had PD during Phase 2 double-blinded treatment were entered in open-label and received selinexor 60 mg tablet twice-weekly during Weeks 1 to 6 of each 6-week (42-day) cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.38', 'groupId': 'OG000', 'lowerLimit': '1.38', 'upperLimit': '2.27'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization in the Phase 2 open label period until the first date of PD or death due to any cause, whichever occurred first (up to 57 months)', 'description': 'PFS was defined as the time from date of randomization in the Phase 2 open-label period until the first date of IRC-confirmed PD per RECIST version 1.1, or death due to any cause. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Phase 2 Open-Label Population (Ph2-OL) consisted of all participants in Phase 2 who were randomized to placebo in the blinded phase, entered open-label period, and received at least one dose of open-label selinexor.'}, {'type': 'SECONDARY', 'title': 'Phase 3 Double Blind: Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3 Double-blinded: Selinexor', 'description': 'Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}, {'id': 'OG001', 'title': 'Phase 3 Double-blinded: Placebo', 'description': 'Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.38', 'groupId': 'OG000', 'lowerLimit': '8.41', 'upperLimit': '13.40'}, {'value': '12.71', 'groupId': 'OG001', 'lowerLimit': '8.54', 'upperLimit': '15.90'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until death due to any cause, whichever occurred first (up to 70 months)', 'description': 'OS was defined as the duration (in months) from the date of randomization to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Ph3-ITT consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment.'}, {'type': 'SECONDARY', 'title': 'Phase 3 Open Label: Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3 Open Label: Selinexor', 'description': 'Participants in the placebo group who had PD during Phase 3 double-blinded treatment, were entered in open-label and received selinexor 60 mg tablet twice-weekly during Weeks 1 to 6 of each 6-week (42-day) cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.18', 'groupId': 'OG000', 'lowerLimit': '5.78', 'upperLimit': '14.69'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization in phase 3 open label period until death due to any cause, whichever occurred first (up to 70 months)', 'description': 'OS was defined as the duration (in months) from the date of randomization in the Phase 3 open-label period to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Ph3-OL consisted of all participants in Phase 3 who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.'}, {'type': 'SECONDARY', 'title': 'Phase 2 Double Blind: Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 Double-blinded: Selinexor', 'description': 'Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}, {'id': 'OG001', 'title': 'Phase 2 Double-blinded: Placebo', 'description': 'Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.31', 'groupId': 'OG000', 'lowerLimit': '10.51', 'upperLimit': '29.57'}, {'value': '16.07', 'groupId': 'OG001', 'lowerLimit': '8.38', 'upperLimit': '23.06'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization until death due to any cause, whichever occurred first (up to 70 months)', 'description': 'OS was defined as the duration (in months) from the date of randomization to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Ph2-ITT consisted of all participants randomized to study treatment in Phase 2, regardless of whether or not they received study treatment.'}, {'type': 'SECONDARY', 'title': 'Phase 2 Open Label: Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 Open Label: Selinexor', 'description': 'Participants in the placebo group who had PD during Phase 2 double-blinded treatment were entered in open-label and received selinexor 60 mg tablet twice-weekly during Weeks 1 to 6 of each 6-week (42-day) cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.90', 'groupId': 'OG000', 'lowerLimit': '4.96', 'upperLimit': '18.92'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization in the Phase 2 open-label period until death due to any cause, whichever occurred first (up to 70 months)', 'description': 'OS was defined as the duration (in months) from the date of randomization in the Phase 2 open-label period to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Ph2-OL consisted of all participants in Phase 2 who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.'}, {'type': 'SECONDARY', 'title': 'Phase 3 Double Blind: Time-to-Progression (TTP) as Per RECIST Version 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3 Double-blinded: Selinexor', 'description': 'Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}, {'id': 'OG001', 'title': 'Phase 3 Double-blinded: Placebo', 'description': 'Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.83', 'groupId': 'OG000', 'lowerLimit': '2.73', 'upperLimit': '4.11'}, {'value': '2.10', 'groupId': 'OG001', 'lowerLimit': '1.51', 'upperLimit': '3.06'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 70 months)', 'description': 'TTP was defined as the time from date of randomization until ICR-determined PD per RECIST version 1.1, or death due to disease progression, whichever occurred first. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Ph3-ITT consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment.'}, {'type': 'SECONDARY', 'title': 'Phase 3 Open Label: Time-to-Progression (TTP) as Per RECIST Version 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3 Open Label: Selinexor', 'description': 'Participants in the placebo group who had PD during Phase 3 double-blinded treatment, were entered in open-label and received selinexor 60 mg tablet twice-weekly during Weeks 1 to 6 of each 6-week (42-day) cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.73', 'groupId': 'OG000', 'lowerLimit': '1.97', 'upperLimit': '4.14'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization in the Phase 3 open label period until the first date of PD or death due to any cause, whichever occurred first (up to 70 months)', 'description': 'TTP was defined as the time from date of randomization in the Phase 3 open-label period until ICR-determined PD per RECIST version 1.1, or death due to disease progression, whichever occurred first. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Ph3-OL consisted of all participants in Phase 3 who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.'}, {'type': 'SECONDARY', 'title': 'Phase 2 Double Blind: Time-to-Progression (TTP) as Per RECIST Version 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 Double-blinded: Selinexor', 'description': 'Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}, {'id': 'OG001', 'title': 'Phase 2 Double-blinded: Placebo', 'description': 'Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.02', 'comment': 'Data could not be estimated due to the higher number (\\>50%) of deaths.', 'groupId': 'OG000', 'lowerLimit': '1.41', 'upperLimit': 'NA'}, {'value': '2.76', 'comment': 'Data could not be estimated due to the higher number (\\>50%) of deaths.', 'groupId': 'OG001', 'lowerLimit': '1.58', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 70 months)', 'description': 'TTP was defined as the time from date of randomization until ICR-determined PD as per RECIST version 1.1, or death due to disease progression, whichever occurred first. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Ph2-ITT consisted of all participants randomized to study treatment in Phase 2, regardless of whether or not they received study treatment.'}, {'type': 'SECONDARY', 'title': 'Phase 2 Open Label: Time-to-Progression (TTP) as Per RECIST Version 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 Open Label: Selinexor', 'description': 'Participants in the placebo group who had PD during Phase 2 double-blinded treatment were entered in open-label and received selinexor 60 mg tablet twice-weekly during Weeks 1 to 6 of each 6-week (42-day) cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.38', 'groupId': 'OG000', 'lowerLimit': '1.38', 'upperLimit': '2.27'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization in the Phase 2 open-label period until the first date of PD or death due to any cause, whichever occurred first (up to 70 months)', 'description': 'TTP was defined as the time from date of randomization in the Phase 2 open-label period until ICR-determined PD per RECIST version 1.1, or death due to disease progression, whichever occurred first. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Ph2-OL consisted of all participants in Phase 2 who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.'}, {'type': 'SECONDARY', 'title': 'Phase 3 Double Blind: Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3 Double-blinded: Selinexor', 'description': 'Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}, {'id': 'OG001', 'title': 'Phase 3 Double-blinded: Placebo', 'description': 'Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '6.1'}, {'value': '0', 'comment': 'Data could not be evaluated due to no CR or PR events in the placebo arm.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until the documentation of CR or PR (up to 70 months)', 'description': 'ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR), per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Ph3-ITT consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment.'}, {'type': 'SECONDARY', 'title': 'Phase 3 Open Label: Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3 Open Label: Selinexor', 'description': 'Participants in the placebo group who had PD during Phase 3 double-blinded treatment, were entered in open-label and received selinexor 60 mg tablet twice-weekly during Weeks 1 to 6 of each 6-week (42-day) cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '11'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization in the Phase 3 open label period until the documentation of CR or PR (up to 70 months)', 'description': 'ORR was defined as the percentage of participants who achieved CR or PR, per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Ph3-OL consisted of all participants in Phase 3 who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.'}, {'type': 'SECONDARY', 'title': 'Phase 2 Double Blind: Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 Double-blinded: Selinexor', 'description': 'Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}, {'id': 'OG001', 'title': 'Phase 2 Double-blinded: Placebo', 'description': 'Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'comment': 'Data could not be evaluated since no participant had CR or PR.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be evaluated since no participant had CR or PR.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until the documentation of CR or PR (up to 70 months)', 'description': 'ORR was defined as the percentage of participants who achieved CR or PR, per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Ph2-ITT consisted of all participants randomized to study treatment in Phase 2, regardless of whether or not they received study treatment.'}, {'type': 'SECONDARY', 'title': 'Phase 2 Open Label: Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 Open Label: Selinexor', 'description': 'Participants in the placebo group who had PD during Phase 2 double-blinded treatment were entered in open-label and received selinexor 60 mg tablet twice-weekly during Weeks 1 to 6 of each 6-week (42-day) cycle.'}], 'classes': [{'title': 'Participants who achieved CR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Participants who achieved PR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization in the Phase 2 open-label period until the documentation of CR or PR (up to 70 months)', 'description': 'ORR was defined as the percentage of participants who achieved CR or PR, per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Ph2-OL consisted of all participants in Phase 2 who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor. Data could not be evaluated due to no CR or PR events.'}, {'type': 'SECONDARY', 'title': 'Phase 3 Double Blind: Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3 Double-blinded: Selinexor', 'description': 'Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}, {'id': 'OG001', 'title': 'Phase 3 Double-blinded: Placebo', 'description': 'Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.39', 'comment': 'Upper and lower limit of 95% CI was not estimable due to lesser number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first occurrence of CR or PR until the first date of PD (up to 70 months)', 'description': 'DOR was defined as the time from first occurrence of CR or PR until the first date of PD per RECIST version 1.1 or death. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Ph3-ITT consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment. Here, "overall number of participants analyzed" signifies those who had CR and PR in specified group/arm and phase.'}, {'type': 'SECONDARY', 'title': 'Phase 3 Double Blind: Progression-free Survival (PFS) as Per Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3 Double-blinded: Selinexor', 'description': 'Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}, {'id': 'OG001', 'title': 'Phase 3 Double-blinded: Placebo', 'description': 'Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.89', 'groupId': 'OG000', 'lowerLimit': '2.76', 'upperLimit': '4.17'}, {'value': '1.87', 'groupId': 'OG001', 'lowerLimit': '1.45', 'upperLimit': '2.89'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization until the first date of disease progression, or death due to any cause whichever occurred first (up to 70 months)', 'description': 'PFS was defined as the time from date of randomization until the first date of PD, per RECIST version 1.1, or death due to any cause as defined by the Investigator based on clinical and/or radiologic criteria. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Ph3-ITT consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment.'}, {'type': 'SECONDARY', 'title': 'Phase 3 Double Blind: Time to Next Treatment (TTNT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3 Double-blinded: Selinexor', 'description': 'Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}, {'id': 'OG001', 'title': 'Phase 3 Double-blinded: Placebo', 'description': 'Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.42', 'groupId': 'OG000', 'lowerLimit': '4.67', 'upperLimit': '6.34'}, {'value': '3.22', 'groupId': 'OG001', 'lowerLimit': '2.56', 'upperLimit': '3.78'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from randomization to the first new antineoplastic therapy or death due to any cause (up to 70 months)', 'description': 'TTNT was defined as time since randomization until the first new antineoplastic therapy or death due to any cause, whichever occurs first.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Ph3-ITT consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment.'}, {'type': 'SECONDARY', 'title': 'Phase 2 Double Blind: Time to Next Treatment (TTNT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 Double-blinded: Selinexor', 'description': 'Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}, {'id': 'OG001', 'title': 'Phase 2 Double-blinded: Placebo', 'description': 'Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.96', 'groupId': 'OG000', 'lowerLimit': '3.91', 'upperLimit': '14.03'}, {'value': '2.92', 'groupId': 'OG001', 'lowerLimit': '2.04', 'upperLimit': '5.06'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from randomization to the first new antineoplastic therapy or death due to any cause (up to 70 months)', 'description': 'TTNT was defined as time since randomization until the first new antineoplastic therapy or death due to any cause, whichever occurs first.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Ph2-ITT consisted of all participants randomized to study treatment in Phase 2, regardless of whether or not they received study treatment.'}, {'type': 'SECONDARY', 'title': 'Phase 3 Double Blind: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3 Double-blinded: Selinexor', 'description': 'Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}, {'id': 'OG001', 'title': 'Phase 3 Double-blinded: Placebo', 'description': 'Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}], 'classes': [{'title': 'Participants with TEAEs', 'categories': [{'measurements': [{'value': '187', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Serious TEAEs', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study drug administration up to 70 months', 'description': 'An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. A TEAE was defined as those AEs that develop or worsen after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Phase 3 Safety Population (Ph3-SAF) consisted of all participants in Phase 3 who had received at least one dose of blinded study treatment.'}, {'type': 'SECONDARY', 'title': 'Phase 3 Open Label: Number of Participants With TEAEs and Serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3 Open Label: Selinexor', 'description': 'Participants in the placebo group who had PD during Phase 3 double-blinded treatment, were entered in open-label and received selinexor 60 mg tablet twice-weekly during Weeks 1 to 6 of each 6-week (42-day) cycle.'}], 'classes': [{'title': 'Participants with TEAEs', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}, {'title': 'Participants with Serious TEAEs', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study drug administration up to 70 months', 'description': 'An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as those AEs that develop or worsen after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Ph3-OL consisted of all participants in Phase 3 who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.'}, {'type': 'SECONDARY', 'title': 'Phase 2 Double Blind: Number of Participants With TEAEs and Serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 Double-blinded: Selinexor', 'description': 'Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}, {'id': 'OG001', 'title': 'Phase 2 Double-blinded: Placebo', 'description': 'Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}], 'classes': [{'title': 'Participants with TEAEs', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Serious TEAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study drug administration up to 70 months', 'description': 'An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as those AEs that develop or worsen after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Phase 2 Safety Population (Ph2-SAF) consisted of all participants in Phase 2 who had received at least one dose of blinded study treatment.'}, {'type': 'SECONDARY', 'title': 'Phase 2 Open Label: Number of Participants With TEAEs and Serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 Open Label: Selinexor', 'description': 'Participants in the placebo group who had PD during Phase 2 double-blinded treatment were entered in open-label and received selinexor 60 mg tablet twice-weekly during Weeks 1 to 6 of each 6-week (42-day) cycle.'}], 'classes': [{'title': 'Participants with TEAEs', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Participants with Serious TEAEs', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study drug administration up to 70 months', 'description': 'An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as those AEs that develop or worsen after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Ph2-OL consisted of all participants in Phase 2 who were randomized to placebo in the blinded phase, entered open-label period, and received at least one dose of open-label selinexor.'}, {'type': 'SECONDARY', 'title': 'Phase 3 Double Blind: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3 Double-blinded: Selinexor', 'description': 'Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}, {'id': 'OG001', 'title': 'Phase 3 Double-blinded: Placebo', 'description': 'Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}], 'classes': [{'title': 'Global Health Status', 'categories': [{'measurements': [{'value': '33.33', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning', 'categories': [{'measurements': [{'value': '20.00', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Role Functioning', 'categories': [{'measurements': [{'value': '16.67', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Functioning', 'categories': [{'measurements': [{'value': '8.33', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning', 'categories': [{'measurements': [{'value': '50.00', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Cognitive Functioning', 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '-22.22', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Nausea and Vomiting', 'categories': [{'measurements': [{'value': '16.67', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Dyspnoea', 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Insomnia', 'categories': [{'measurements': [{'value': '33.33', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Appetite Loss', 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhoea', 'categories': [{'measurements': [{'value': '33.33', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Financial Difficulties', 'categories': [{'measurements': [{'value': '-66.67', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Day 1387', 'description': "The QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of patients with cancer. QLQ-C30 contains 30 questions that include five functional scales (physical, role, emotional, social, and cognitive functioning); three symptom scales (fatigue, nausea/vomiting and pain); six single-item symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties); and global health status/quality of life (QoL). Most questions used a 4-point scale (from 1 'Not at all' to 4 'Very much'); 2 questions used a 7-point scale (from 1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to a 0-100 scale. For the functional scales and the global health status/QoL, a higher score represents a better level of functioning (better health status); for the symptom scales/items, a higher score represents a higher level of symptomatology/problems (worse health status).", 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Ph3-ITT consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Phase 3 Open Label: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3 Open Label: Selinexor', 'description': 'Participants in the placebo group who had PD during Phase 3 double-blinded treatment, were entered in open-label and received selinexor 60 mg tablet twice-weekly during Weeks 1 to 6 of each 6-week (42-day) cycle.'}], 'classes': [{'title': 'Global Health Status', 'categories': [{'measurements': [{'value': '-16.67', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning', 'categories': [{'measurements': [{'value': '-40.00', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Role Functioning', 'categories': [{'measurements': [{'value': '-33.33', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Functioning', 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning', 'categories': [{'measurements': [{'value': '-50.00', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Cognitive Functioning', 'categories': [{'measurements': [{'value': '-16.67', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '66.67', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Nausea and Vomiting', 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Dyspnoea', 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Insomnia', 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Appetite Loss', 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhoea', 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Financial Difficulties', 'categories': [{'measurements': [{'value': '100.00', 'spread': 'NA', 'comment': 'Here, "NA" signifies standard deviation was not estimated due to single participant.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Day 379', 'description': "The QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of patients with cancer. QLQ-C30 contains 30 questions that include five functional scales (physical, role, emotional, social, and cognitive functioning); three symptom scales (fatigue, nausea/vomiting and pain); six single-item symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties); and global health status/quality of life (QoL). Most questions used a 4-point scale (from 1 'Not at all' to 4 'Very much'); 2 questions used a 7-point scale (from 1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to a 0-100 scale. For the functional scales and the global health status/QoL, a higher score represents a better level of functioning (better health status); for the symptom scales/items, a higher score represents a higher level of symptomatology/problems (worse health status).", 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Ph3-OL consisted of all participants in Phase 3 who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 2 Double-blinded: Selinexor', 'description': 'Participants received a fixed blinding dose of 60 milligrams (mg) selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}, {'id': 'FG001', 'title': 'Phase 2 Double-blinded: Placebo', 'description': 'Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}, {'id': 'FG002', 'title': 'Phase 3 Double-blinded: Selinexor', 'description': 'Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}, {'id': 'FG003', 'title': 'Phase 3 Double-blinded: Placebo', 'description': 'Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}, {'id': 'FG004', 'title': 'Phase 2 Open-label: Selinexor', 'description': 'Participants in the placebo group who had PD during Phase 2 double-blinded treatment were entered in open-label and received selinexor 60 mg tablet twice-weekly during Weeks 1 to 6 of each 6-week (42-day) cycle.'}, {'id': 'FG005', 'title': 'Phase 3 Open-label: Selinexor', 'description': 'Participants in the placebo group who had PD during Phase 3 double-blinded treatment, were entered in open-label and received selinexor 60 mg tablet twice-weekly during Weeks 1 to 6 of each 6-week (42-day) cycle.'}], 'periods': [{'title': 'Period 1: Double-blinded Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '188'}, {'groupId': 'FG003', 'numSubjects': '97'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '187'}, {'groupId': 'FG003', 'numSubjects': '97'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '187'}, {'groupId': 'FG003', 'numSubjects': '97'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Randomized but no treatment', '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'}]}]}, {'title': 'Period 2: Open Label Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Participants in the placebo group who had PD during the Phase 2 double-blinded treatment, switched to open-label selinexor.', 'groupId': 'FG004', 'numSubjects': '24'}, {'comment': 'Participants in the placebo group who had PD during the Phase 3 double-blinded treatment, switched to open-label selinexor.', 'groupId': 'FG005', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '24'}, {'groupId': 'FG005', 'numSubjects': '63'}]}, {'type': 'NOT 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'}]}]}], 'recruitmentDetails': 'The study was conducted at 71 sites in the United States, Canada, Germany, Belgium, Israel, United Kingdom, France, Spain, Italy, and Sweden. A total of 342 participants were enrolled, out of which 57 participants were randomized to receive study treatment in Phase 2 and 285 participants randomized, of which 284 participants received study treatment in Phase 3.', 'preAssignmentDetails': 'This study consisted of 2 phases (2 and 3), where participants were randomized to selinexor or placebo in double-blind treatment. Participants in the placebo group who had progressive disease (PD) during the phase 2 and 3 double-blinded treatment could crossover to open-label selinexor treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}, {'value': '342', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 2 Double-blinded: Selinexor', 'description': 'Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}, {'id': 'BG001', 'title': 'Phase 2 Double-blinded: Placebo', 'description': 'Participants received a fixed blinding dose of placebo matched to Selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}, {'id': 'BG002', 'title': 'Phase 3 Double-blinded: Selinexor', 'description': 'Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}, {'id': 'BG003', 'title': 'Phase 3 Double-blinded: Placebo', 'description': 'Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '168', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '130', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '212', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}, {'value': '278', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}, {'value': '262', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-21', 'size': 4842432, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-22T03:57', 'hasProtocol': True}, {'date': '2020-09-20', 'size': 1608508, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-10-22T03:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 342}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-05', 'studyFirstSubmitDate': '2015-10-13', 'resultsFirstSubmitDate': '2021-11-08', 'studyFirstSubmitQcDate': '2015-11-13', 'lastUpdatePostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-08', 'studyFirstPostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 3 Double Blind: Progression-free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1', 'timeFrame': 'From the date of randomization until the first date of disease progression, or death due to any cause whichever occurred first (up to 57 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 version 1.1, 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.'}, {'measure': 'Phase 3 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1', 'timeFrame': 'From the date of randomization in the Phase 3 open label period until the first date of disease progression, or death due to any cause whichever occurred first (up to 57 months)', 'description': 'PFS was defined as the time from the date of randomization in the Phase 3 open-label period until the first date of IRC-confirmed PD per RECIST version 1.1, or death due to any cause. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.'}, {'measure': 'Phase 2 Double Blind: Progression-free Survival (PFS) as Per RECIST Version 1.1', 'timeFrame': 'From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 57 months)', 'description': 'PFS was defined as the time from date of randomization until the first date of IRC-confirmed PD per RECIST version 1.1, or death due to any cause. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.'}, {'measure': 'Phase 2 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1', 'timeFrame': 'From date of randomization in the Phase 2 open label period until the first date of PD or death due to any cause, whichever occurred first (up to 57 months)', 'description': 'PFS was defined as the time from date of randomization in the Phase 2 open-label period until the first date of IRC-confirmed PD per RECIST version 1.1, or death due to any cause. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.'}], 'secondaryOutcomes': [{'measure': 'Phase 3 Double Blind: Overall Survival (OS)', 'timeFrame': 'From date of randomization until death due to any cause, whichever occurred first (up to 70 months)', 'description': 'OS was defined as the duration (in months) from the date of randomization to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier.'}, {'measure': 'Phase 3 Open Label: Overall Survival (OS)', 'timeFrame': 'From date of randomization in phase 3 open label period until death due to any cause, whichever occurred first (up to 70 months)', 'description': 'OS was defined as the duration (in months) from the date of randomization in the Phase 3 open-label period to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier.'}, {'measure': 'Phase 2 Double Blind: Overall Survival (OS)', 'timeFrame': 'From the date of randomization until death due to any cause, whichever occurred first (up to 70 months)', 'description': 'OS was defined as the duration (in months) from the date of randomization to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier.'}, {'measure': 'Phase 2 Open Label: Overall Survival (OS)', 'timeFrame': 'From date of randomization in the Phase 2 open-label period until death due to any cause, whichever occurred first (up to 70 months)', 'description': 'OS was defined as the duration (in months) from the date of randomization in the Phase 2 open-label period to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier.'}, {'measure': 'Phase 3 Double Blind: Time-to-Progression (TTP) as Per RECIST Version 1.1', 'timeFrame': 'From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 70 months)', 'description': 'TTP was defined as the time from date of randomization until ICR-determined PD per RECIST version 1.1, or death due to disease progression, whichever occurred first. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.'}, {'measure': 'Phase 3 Open Label: Time-to-Progression (TTP) as Per RECIST Version 1.1', 'timeFrame': 'From date of randomization in the Phase 3 open label period until the first date of PD or death due to any cause, whichever occurred first (up to 70 months)', 'description': 'TTP was defined as the time from date of randomization in the Phase 3 open-label period until ICR-determined PD per RECIST version 1.1, or death due to disease progression, whichever occurred first. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.'}, {'measure': 'Phase 2 Double Blind: Time-to-Progression (TTP) as Per RECIST Version 1.1', 'timeFrame': 'From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 70 months)', 'description': 'TTP was defined as the time from date of randomization until ICR-determined PD as per RECIST version 1.1, or death due to disease progression, whichever occurred first. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.'}, {'measure': 'Phase 2 Open Label: Time-to-Progression (TTP) as Per RECIST Version 1.1', 'timeFrame': 'From date of randomization in the Phase 2 open-label period until the first date of PD or death due to any cause, whichever occurred first (up to 70 months)', 'description': 'TTP was defined as the time from date of randomization in the Phase 2 open-label period until ICR-determined PD per RECIST version 1.1, or death due to disease progression, whichever occurred first. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.'}, {'measure': 'Phase 3 Double Blind: Overall Response Rate (ORR)', 'timeFrame': 'From date of randomization until the documentation of CR or PR (up to 70 months)', 'description': 'ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR), per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.'}, {'measure': 'Phase 3 Open Label: Overall Response Rate (ORR)', 'timeFrame': 'From date of randomization in the Phase 3 open label period until the documentation of CR or PR (up to 70 months)', 'description': 'ORR was defined as the percentage of participants who achieved CR or PR, per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.'}, {'measure': 'Phase 2 Double Blind: Overall Response Rate (ORR)', 'timeFrame': 'From date of randomization until the documentation of CR or PR (up to 70 months)', 'description': 'ORR was defined as the percentage of participants who achieved CR or PR, per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.'}, {'measure': 'Phase 2 Open Label: Overall Response Rate (ORR)', 'timeFrame': 'From date of randomization in the Phase 2 open-label period until the documentation of CR or PR (up to 70 months)', 'description': 'ORR was defined as the percentage of participants who achieved CR or PR, per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.'}, {'measure': 'Phase 3 Double Blind: Duration of Response (DOR)', 'timeFrame': 'From first occurrence of CR or PR until the first date of PD (up to 70 months)', 'description': 'DOR was defined as the time from first occurrence of CR or PR until the first date of PD per RECIST version 1.1 or death. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.'}, {'measure': 'Phase 3 Double Blind: Progression-free Survival (PFS) as Per Investigator Assessment', 'timeFrame': 'From the date of randomization until the first date of disease progression, or death due to any cause whichever occurred first (up to 70 months)', 'description': 'PFS was defined as the time from date of randomization until the first date of PD, per RECIST version 1.1, or death due to any cause as defined by the Investigator based on clinical and/or radiologic criteria. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.'}, {'measure': 'Phase 3 Double Blind: Time to Next Treatment (TTNT)', 'timeFrame': 'Time from randomization to the first new antineoplastic therapy or death due to any cause (up to 70 months)', 'description': 'TTNT was defined as time since randomization until the first new antineoplastic therapy or death due to any cause, whichever occurs first.'}, {'measure': 'Phase 2 Double Blind: Time to Next Treatment (TTNT)', 'timeFrame': 'Time from randomization to the first new antineoplastic therapy or death due to any cause (up to 70 months)', 'description': 'TTNT was defined as time since randomization until the first new antineoplastic therapy or death due to any cause, whichever occurs first.'}, {'measure': 'Phase 3 Double Blind: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs', 'timeFrame': 'From start of study drug administration up to 70 months', 'description': 'An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. A TEAE was defined as those AEs that develop or worsen after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.'}, {'measure': 'Phase 3 Open Label: Number of Participants With TEAEs and Serious TEAEs', 'timeFrame': 'From start of study drug administration up to 70 months', 'description': 'An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as those AEs that develop or worsen after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.'}, {'measure': 'Phase 2 Double Blind: Number of Participants With TEAEs and Serious TEAEs', 'timeFrame': 'From start of study drug administration up to 70 months', 'description': 'An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as those AEs that develop or worsen after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.'}, {'measure': 'Phase 2 Open Label: Number of Participants With TEAEs and Serious TEAEs', 'timeFrame': 'From start of study drug administration up to 70 months', 'description': 'An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as those AEs that develop or worsen after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.'}, {'measure': 'Phase 3 Double Blind: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)', 'timeFrame': 'Baseline up to Day 1387', 'description': "The QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of patients with cancer. QLQ-C30 contains 30 questions that include five functional scales (physical, role, emotional, social, and cognitive functioning); three symptom scales (fatigue, nausea/vomiting and pain); six single-item symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties); and global health status/quality of life (QoL). Most questions used a 4-point scale (from 1 'Not at all' to 4 'Very much'); 2 questions used a 7-point scale (from 1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to a 0-100 scale. For the functional scales and the global health status/QoL, a higher score represents a better level of functioning (better health status); for the symptom scales/items, a higher score represents a higher level of symptomatology/problems (worse health status)."}, {'measure': 'Phase 3 Open Label: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)', 'timeFrame': 'Baseline up to Day 379', 'description': "The QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of patients with cancer. QLQ-C30 contains 30 questions that include five functional scales (physical, role, emotional, social, and cognitive functioning); three symptom scales (fatigue, nausea/vomiting and pain); six single-item symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties); and global health status/quality of life (QoL). Most questions used a 4-point scale (from 1 'Not at all' to 4 'Very much'); 2 questions used a 7-point scale (from 1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to a 0-100 scale. For the functional scales and the global health status/QoL, a higher score represents a better level of functioning (better health status); for the symptom scales/items, a higher score represents a higher level of symptomatology/problems (worse health status)."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced unresectable dedifferentiated liposarcoma', 'selinexor', 'KCP-330', 'Karyopharm', 'Phase 2 / 3', 'dedifferentiated liposarcoma', 'Liposarcoma'], 'conditions': ['Dedifferentiated Liposarcoma']}, 'referencesModule': {'references': [{'pmid': '35394800', 'type': 'DERIVED', 'citation': 'Gounder MM, Razak AA, Somaiah N, Chawla S, Martin-Broto J, Grignani G, Schuetze SM, Vincenzi B, Wagner AJ, Chmielowski B, Jones RL, Riedel RF, Stacchiotti S, Loggers ET, Ganjoo KN, Le Cesne A, Italiano A, Garcia Del Muro X, Burgess M, Piperno-Neumann S, Ryan C, Mulcahy MF, Forscher C, Penel N, Okuno S, Elias A, Hartner L, Philip T, Alcindor T, Kasper B, Reichardt P, Lapeire L, Blay JY, Chevreau C, Valverde Morales CM, Schwartz GK, Chen JL, Deshpande H, Davis EJ, Nicholas G, Groschel S, Hatcher H, Duffaud F, Herraez AC, Beveridge RD, Badalamenti G, Eriksson M, Meyer C, von Mehren M, Van Tine BA, Gotze K, Mazzeo F, Yakobson A, Zick A, Lee A, Gonzalez AE, Napolitano A, Dickson MA, Michel D, Meng C, Li L, Liu J, Ben-Shahar O, Van Domelen DR, Walker CJ, Chang H, Landesman Y, Shah JJ, Shacham S, Kauffman MG, Attia S. Selinexor in Advanced, Metastatic Dedifferentiated Liposarcoma: A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial. J Clin Oncol. 2022 Aug 1;40(22):2479-2490. doi: 10.1200/JCO.21.01829. Epub 2022 Apr 8.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 342 total patients will be randomized to study treatment (selinexor or placebo).', 'detailedDescription': 'In the Phase 2 portion of the study, 57 patients were randomized to selinexor (60 mg) or placebo at a 1:1 allocation ratio.\n\nIn the Phase 3 portion of the study, approximately 285 patients will be randomized to selinexor (60 mg) or placebo with a 2:1 allocation ratio.\n\nPatients who progress during the blinded portion of the study will be unblinded and if receiving:\n\n* placebo, may cross over to open-label selinexor (60mg twice-weekly)\n* selinexor, will be withdrawn from further treatment and followed for survival\n\nStudy treatment will be given twice-weekly on Day 1 and Day 3 during Weeks 1-6 of each six-week (42 day) cycle until disease progression or intolerability.\n\nTreatment will continue until one or more of the following occurs:\n\n* Disease progression, as defined by RECIST v1.1 Response Criteria\n* Clinical progression, as determined by the treating physician\n* Unacceptable adverse events (AEs) or failure to tolerate study treatment\n* Patient withdrawal\n* Patient discontinuation due to non-compliance'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients ≥12 years of age\n2. Body surface area (BSA) ≥ 1.2 m2\n3. Histologic evidence of DDLS at any time prior to randomization AND current evidence of DDLS requiring treatment\n4. Must have measurable disease per RECIST v1.1 Response Criteria\n5. Radiologic evidence of disease progression within 6 months prior to randomization. If the patient received other intervening therapy after documented disease progression, further disease progression must be documented after the completion of the intervening therapy\n6. Must have had at least 2 prior lines of systemic therapy for liposarcoma (not to exceed 5 prior lines)\n7. If patient received any previous systemic therapy, the last dose must have been ≥ 21 days prior to randomization (or ≥ 5 half-lives of that drug, whichever is shorter) with all clinically significant therapy-related toxicities having resolved to ≤ Grade 1\n\nExclusion Criteria:\n\n1. Patients with pure well-differentiated liposarcoma (WDLS), myxoid/round cell or pleomorphic tumor histologic subtypes\n2. Known active hepatitis B (HepB), hepatitis C (HepC) or human immunodeficiency virus (HIV) infection\n3. Known central nervous system metastases'}, 'identificationModule': {'nctId': 'NCT02606461', 'acronym': 'SEAL', 'briefTitle': 'Selinexor in Advanced Liposarcoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Karyopharm Therapeutics Inc'}, 'officialTitle': 'A Phase 2-3, Multicenter, Randomized, Double-blind Study of Selinexor (KPT-330) Versus Placebo in Patients With Advanced Unresectable Dedifferentiated Liposarcoma (DDLS)', 'orgStudyIdInfo': {'id': 'KCP-330-020'}, 'secondaryIdInfos': [{'id': '2015-003594-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 2 Double-blinded: Selinexor', 'description': 'Participants received a fixed blinding dose of 60 milligrams (mg) selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle until progressive disease (PD).', 'interventionNames': ['Drug: Selinexor']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 3 Double-blinded: Selinexor', 'description': 'Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle until PD.', 'interventionNames': ['Drug: Selinexor']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase 2 Double-blinded: Placebo Followed by Open Label- Selinexor', 'description': 'Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle until PD in double-blinded treatment period. Participants in the placebo group who had PD during the Phase 2 double-blinded treatment, will be elected to cross over to open-label selinexor.', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase 3 Double-blinded: Placebo Followed by Open Label- Selinexor', 'description': 'Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle until PD or development of unacceptable toxicity. Participants in the placebo group who had PD during the Phase 3 double-blinded treatment, will be elected to cross over to open-label selinexor.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Selinexor', 'type': 'DRUG', 'otherNames': ['KPT-330'], 'description': 'Selinexor 60mg', 'armGroupLabels': ['Phase 2 Double-blinded: Selinexor', 'Phase 3 Double-blinded: Selinexor']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['sugar pill'], 'armGroupLabels': ['Phase 2 Double-blinded: Placebo Followed by Open Label- Selinexor', 'Phase 3 Double-blinded: Placebo Followed by Open Label- Selinexor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 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