Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-27 @ 5:09 PM
Study NCT ID:
NCT01607905
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2012-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Study of KPT-330 (Selinexor) in Patients With Advanced or Metastatic Solid Tumor Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C585161', 'term': 'selinexor'}, {'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jshah@karyopharm.com', 'phone': '(617) 658-0600', 'title': 'Jatin Shah', 'organization': 'Karyopharm Therapeutics Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of study drug administration to 30 days after last dose of study treatment (maximum duration of 45 months)', 'description': 'As pre-specified in the study Protocol data were not collected per dose level. The limited data available based on cancer stratification as pre-specified in the protocol is presented.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A (Colorectal Cancer)', 'description': 'Participants with colorectal cancer with liver metastasis received oral selinexor as a single agent in eight schedules- Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW(Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 6: ≥20 mg/m\\^2 BIW (Days 1 and 4) after 500 mg (Cycle 1, Week 1) to 1000 mg (Cycle 1, Week 2 onwards) acetaminophen (given 1 hour prior to each selinexor dose) up to 8 doses/cycle(28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.', 'otherNumAtRisk': 59, 'otherNumAffected': 59, 'seriousNumAtRisk': 59, 'seriousNumAffected': 30}, {'id': 'EG001', 'title': 'Arm B (Gynecological Cancer)', 'description': 'Participants with gynecological cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.', 'otherNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'seriousNumAffected': 13}, {'id': 'EG002', 'title': 'Arm C (Squamous Cell Cancer)', 'description': 'Participants with squamous cell cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.', 'otherNumAtRisk': 21, 'otherNumAffected': 21, 'seriousNumAtRisk': 21, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': 'Arm D (Castrate-resistant Prostate Cancer)', 'description': 'Participants with CRPC received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.', 'otherNumAtRisk': 21, 'otherNumAffected': 21, 'seriousNumAtRisk': 21, 'seriousNumAffected': 8}, {'id': 'EG004', 'title': 'Arm E (Glioblastoma Multiforme)', 'description': 'Participants with GBM received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Arm F (Melanoma)', 'description': 'Participants with melanoma received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.', 'otherNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'seriousNumAffected': 5}, {'id': 'EG006', 'title': 'Arm G (Other Solid Tumors)', 'description': 'Participants with other solid tumors received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.', 'otherNumAtRisk': 47, 'otherNumAffected': 46, 'seriousNumAtRisk': 47, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Periorbital oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 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{'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Cerebellar syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Cerebral thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Facial paresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Laryngeal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Pulmonary thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '47', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Colorectal Cancer)', 'description': 'Participants with colorectal cancer with liver metastasis received oral selinexor as a single agent in eight schedules- Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW(Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 6: ≥20 mg/m\\^2 BIW (Days 1 and 4) after 500 mg (Cycle 1, Week 1) to 1000 mg (Cycle 1, Week 2 onwards) acetaminophen (given 1 hour prior to each selinexor dose) up to 8 doses/cycle(28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Arm B (Gynecological Cancer)', 'description': 'Participants with gynecological cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Arm C (Squamous Cell Cancer)', 'description': 'Participants with squamous cell cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Arm D (Castrate-resistant Prostate Cancer)', 'description': 'Participants with CRPC received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Arm E (Glioblastoma Multiforme)', 'description': 'Participants with GBM received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Arm F (Melanoma)', 'description': 'Participants with melanoma received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Arm G (Other Solid Tumors)', 'description': 'Participants with other solid tumors received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}], 'classes': [{'title': 'Participants with TEAEs', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}]}]}, {'title': 'Participants with TESAEs', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study drug administration to 30 days after last dose of study treatment (maximum duration of 45 months)', 'description': 'An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAE was defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) was defined as an AE that meets one or more of the mentioned criteria; is fatal, life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events. Number of participants with TEAEs and TESAEs were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of selinexor. As pre-specified in the study Protocol data were not collected per dose level. The limited data available based on cancer stratification as pre-specified in the protocol is presented.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-related Treatment-emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '47', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Colorectal Cancer)', 'description': 'Participants with colorectal cancer with liver metastasis received oral selinexor as a single agent in eight schedules- Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW(Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 6: ≥20 mg/m\\^2 BIW (Days 1 and 4) after 500 mg (Cycle 1, Week 1) to 1000 mg (Cycle 1, Week 2 onwards) acetaminophen (given 1 hour prior to each selinexor dose) up to 8 doses/cycle(28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Arm B (Gynecological Cancer)', 'description': 'Participants with gynecological cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Arm C (Squamous Cell Cancer)', 'description': 'Participants with squamous cell cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Arm D (Castrate-resistant Prostate Cancer)', 'description': 'Participants with CRPC received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Arm E (Glioblastoma Multiforme)', 'description': 'Participants with GBM received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Arm F (Melanoma)', 'description': 'Participants with melanoma received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Arm G (Other Solid Tumors)', 'description': 'Participants with other solid tumors received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}], 'classes': [{'title': 'Participants with Treatment-related TEAEs', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '45', 'groupId': 'OG006'}]}]}, {'title': 'Participants with Treatment-related TESAEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study drug administration to 30 days after last dose of study treatment (maximum duration of 45 months)', 'description': 'An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAE was defined as an adverse event with an onset that occurs after receiving study drug. A treatment-related AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product; the event had a causal relationship with the treatment or usage.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of selinexor. As pre-specified in the study Protocol data were not collected per dose level. The limited data available based on cancer stratification as pre-specified in the protocol is presented.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) Greater Than or Equal to Grade 3, Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '47', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Colorectal Cancer)', 'description': 'Participants with colorectal cancer with liver metastasis received oral selinexor as a single agent in eight schedules- Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW(Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 6: ≥20 mg/m\\^2 BIW (Days 1 and 4) after 500 mg (Cycle 1, Week 1) to 1000 mg (Cycle 1, Week 2 onwards) acetaminophen (given 1 hour prior to each selinexor dose) up to 8 doses/cycle(28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Arm B (Gynecological Cancer)', 'description': 'Participants with gynecological cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Arm C (Squamous Cell Cancer)', 'description': 'Participants with squamous cell cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Arm D (Castrate-resistant Prostate Cancer)', 'description': 'Participants with CRPC received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Arm E (Glioblastoma Multiforme)', 'description': 'Participants with GBM received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Arm F (Melanoma)', 'description': 'Participants with melanoma received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Arm G (Other Solid Tumors)', 'description': 'Participants with other solid tumors received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study drug administration to 30 days after last dose of study treatment (maximum duration of 45 months)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. A treatment related AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event had a causal relationship with the treatment or usage.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of selinexor. As pre-specified in the study Protocol data were not collected per dose level. The limited data available based on cancer stratification as pre-specified in the protocol is presented.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced Dose Limiting Toxicity (DLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '47', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Colorectal Cancer)', 'description': 'Participants with colorectal cancer with liver metastasis received oral selinexor as a single agent in eight schedules- Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW(Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 6: ≥20 mg/m\\^2 BIW (Days 1 and 4) after 500 mg (Cycle 1, Week 1) to 1000 mg (Cycle 1, Week 2 onwards) acetaminophen (given 1 hour prior to each selinexor dose) up to 8 doses/cycle(28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Arm B (Gynecological Cancer)', 'description': 'Participants with gynecological cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Arm C (Squamous Cell Cancer)', 'description': 'Participants with squamous cell cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Arm D (Castrate-resistant Prostate Cancer)', 'description': 'Participants with CRPC received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Arm E (Glioblastoma Multiforme)', 'description': 'Participants with GBM received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Arm F (Melanoma)', 'description': 'Participants with melanoma received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Arm G (Other Solid Tumors)', 'description': 'Participants with other solid tumors received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 1 only (28-day cycle)', 'description': 'Evaluation of DLTs was only conducted in participants who participated in the Dose-escalation Phase. A DLT was defined as any of the following, considered possibly related to drug administration, occurring in the first 28 days (or 21 days for participants on Schedule 8) at the target dose (ie, for Schedule 2 this meant the first 4 weeks after the 12 mg/m2 run-in week): Missed selinexor doses due to drug-related toxicities, discontinuation of a participant due to a toxicity that was at least possibly related to study drug before completing Cycle 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'DLT Evaluable Population included all participants enrolled to the study during the dose-escalation phase who met the inclusion/exclusion criteria on first day of dosing and completed at least 1 cycle of therapy or experienced a DLT during the first cycle. As pre-specified in the study Protocol data were not collected per dose level. The limited data available based on cancer stratification as pre-specified in the protocol is presented.'}, {'type': 'PRIMARY', 'title': 'Recommended Phase 2 Dose (RP2D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arms A to G: Overall Solid Tumor Malignancies', 'description': 'Participants with colorectal cancer with liver metastasis, gynecological cancer, squamous cell cancer, CRPC, GBM, melanoma, other solid tumors received oral selinexor as a single agent in eight schedules, schedule 1. ≤12 mg/m\\^2 TIW in Weeks 1 and 3, BIW in Weeks 2 and 4, schedule 2. \\>12 mg/m\\^2 TIW in Weeks 1 and 3, BIW in Weeks 2 and 4, schedule 3. ≥ 30 mg/m\\^2 BIW (Days 1 and 3), schedule 4. ≥20 mg/m\\^2 BIW (Days 1 and 2), schedule 5. ≥35 mg/m\\^2 BIW (Days 1 and 4), schedule 6. ≥20 mg/m\\^2 BIW (Days 1 and 4), schedule 7. ≥50 mg/m\\^2 once weekly (QW), schedule 8. ≥45 mg/m\\^2 BIW (Days 1 and 3) until disease progression, death, or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of study drug administration to 30 days after last dose of study treatment (maximum duration of 45 months)', 'description': 'The RP2D was the maximum tolerated dose (MTD) or less. MTD was defined as the next lower dose level below the one in which \\>1 of 3 participants or ≥2 of 6 participants experienced DLT, provided that dose level was ≤25 percent (%) lower than the highest (intolerable) dose tested. If the projected MTD was \\>25% lower than the highest dose tested, then an additional cohort of ≥3 participants was added at a dose that was intermediate between the intolerable dose and the next lower dose.', 'unitOfMeasure': 'mg/m^2', 'reportingStatus': 'POSTED', 'populationDescription': "Safety Population included all participants who received at least one dose of selinexor. The data in terms of dose was reported as combined data for participants from all arms, pre-specified in protocol. Here, 'Overall number of participants analyzed' signifies participants with available data for the outcome measure."}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Selinexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '4', 'groupId': 'OG014'}, {'value': '7', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}, {'value': '2', 'groupId': 'OG017'}, {'value': '3', 'groupId': 'OG018'}]}], 'groups': [{'id': 'OG000', 'title': 'Selinexor Dose: 3 mg/m^2', 'description': 'Participants received 3 milligram per square meter (mg/m\\^2) of selinexor for Cycle1 Day1.'}, {'id': 'OG001', 'title': 'Selinexor Dose: 6 mg/m^2', 'description': 'Participants received single oral dose of 6 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG002', 'title': 'Selinexor Dose: 12 mg/m^2', 'description': 'Participants received single oral dose of 12 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG003', 'title': 'Selinexor Dose: 16.8 mg/m^2', 'description': 'Participants received single oral dose of 16.8 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG004', 'title': 'Selinexor Dose: 20 mg/m^2', 'description': 'Participants received single oral dose of 20 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG005', 'title': 'Selinexor Dose: 23 mg/m^2', 'description': 'Participants received single oral dose of 23 mg/m\\^2 Selinexor for Cycle1Day1.'}, {'id': 'OG006', 'title': 'Selinexor Dose: 28 mg/m^2', 'description': 'Participants received single oral dose of 28 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG007', 'title': 'Selinexor Dose: 30 mg/m^2', 'description': 'Participants received single oral dose of 30 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG008', 'title': 'Selinexor Dose: 35 mg/m^2', 'description': 'Participants received single oral dose of 35 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG009', 'title': 'Selinexor Dose: 39 mg/m^2', 'description': 'Participants received single oral dose of 39 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG010', 'title': 'Selinexor Dose: 40 mg/m^2', 'description': 'Participants received single oral dose of 40 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG011', 'title': 'Selinexor Dose: 45 mg/m^2', 'description': 'Participants received single oral dose of 45 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG012', 'title': 'Selinexor Dose: 50 mg/m^2', 'description': 'Participants received single oral dose of 50 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG013', 'title': 'Selinexor Dose: 55 mg/m^2', 'description': 'Participants received single oral dose of 55 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG014', 'title': 'Selinexor Dose: 58 mg/m^2', 'description': 'Participants received single oral dose of 58 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG015', 'title': 'Selinexor Dose: 65 mg/m^2', 'description': 'Participants received single oral dose of 65 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG016', 'title': 'Selinexor Dose: 70 mg/m^2', 'description': 'Participants received single oral dose of 70 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG017', 'title': 'Selinexor Dose: 80 mg/m^2', 'description': 'Participants received single oral dose of 80 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG018', 'title': 'Selinexor Dose: 85 mg/m^2', 'description': 'Participants received single oral dose of 85 mg/m\\^2 Selinexor for Cycle1 Day1.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '75', 'spread': '38.2', 'groupId': 'OG001'}, {'value': '149', 'spread': '32', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '220', 'spread': '44.5', 'groupId': 'OG004'}, {'value': '308', 'spread': '12.1', 'groupId': 'OG005'}, {'value': '293', 'spread': '58.3', 'groupId': 'OG006'}, {'value': '413', 'spread': '46.7', 'groupId': 'OG007'}, {'value': '349', 'spread': '25.4', 'groupId': 'OG008'}, {'value': '528', 'spread': '12.5', 'groupId': 'OG009'}, {'value': '442', 'spread': '63.6', 'groupId': 'OG010'}, {'value': '390', 'spread': '25.3', 'groupId': 'OG011'}, {'value': '507', 'spread': '57.8', 'groupId': 'OG012'}, {'value': '505', 'spread': '18.2', 'groupId': 'OG013'}, {'value': '561', 'spread': '45.4', 'groupId': 'OG014'}, {'value': '896', 'spread': '71.7', 'groupId': 'OG015'}, {'value': '521', 'groupId': 'OG016'}, {'value': '765', 'spread': '6.6', 'groupId': 'OG017'}, {'value': '1371', 'spread': '31.1', 'groupId': 'OG018'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes', 'description': 'Cmax was defined as maximum observed concentration, taken directly from the plasma concentration data.', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacokinetic (PK) population consisted of all participants who received selinexor, and had evaluable PK for at least one dosing occasion. Data for the PK parameters were planned and analyzed based on doses and % coefficient of variation was not evaluable for arms where single participant was analyzed. Here, 'Overall number of participants analyzed' signifies participants with available data for the outcome measure."}, {'type': 'SECONDARY', 'title': 'Time of Maximum Observed Concentration in Plasma (Tmax) of Selinexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '4', 'groupId': 'OG014'}, {'value': '7', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}, {'value': '2', 'groupId': 'OG017'}, {'value': '3', 'groupId': 'OG018'}]}], 'groups': [{'id': 'OG000', 'title': 'Selinexor Dose: 3 mg/m^2', 'description': 'Participants received 3 mg/m\\^2 of selinexor for Cycle1 Day1.'}, {'id': 'OG001', 'title': 'Selinexor Dose: 6 mg/m^2', 'description': 'Participants received single oral dose of 6 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG002', 'title': 'Selinexor Dose: 12 mg/m^2', 'description': 'Participants received single oral dose of 12 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG003', 'title': 'Selinexor Dose: 16.8 mg/m^2', 'description': 'Participants received single oral dose of 16.8 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG004', 'title': 'Selinexor Dose: 20 mg/m^2', 'description': 'Participants received single oral dose of 20 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG005', 'title': 'Selinexor Dose: 23 mg/m^2', 'description': 'Participants received single oral dose of 23 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG006', 'title': 'Selinexor Dose: 28 mg/m^2', 'description': 'Participants received single oral dose of 28 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG007', 'title': 'Selinexor Dose: 30 mg/m^2', 'description': 'Participants received single oral dose of 30 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG008', 'title': 'Selinexor Dose: 35 mg/m^2', 'description': 'Participants received single oral dose of 35 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG009', 'title': 'Selinexor Dose: 39 mg/m^2', 'description': 'Participants received single oral dose of 39 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG010', 'title': 'Selinexor Dose: 40 mg/m^2', 'description': 'Participants received single oral dose of 40 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG011', 'title': 'Selinexor Dose: 45 mg/m^2', 'description': 'Participants received single oral dose of 45 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG012', 'title': 'Selinexor Dose: 50 mg/m^2', 'description': 'Participants received single oral dose of 50 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG013', 'title': 'Selinexor Dose: 55 mg/m^2', 'description': 'Participants received single oral dose of 55 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG014', 'title': 'Selinexor Dose: 58 mg/m^2', 'description': 'Participants received single oral dose of 58 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG015', 'title': 'Selinexor Dose: 65 mg/m^2', 'description': 'Participants received single oral dose of 65 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG016', 'title': 'Selinexor Dose: 70 mg/m^2', 'description': 'Participants received single oral dose of 70 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG017', 'title': 'Selinexor Dose: 80 mg/m^2', 'description': 'Participants received single oral dose of 80 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG018', 'title': 'Selinexor Dose: 85 mg/m^2', 'description': 'Participants received single oral dose of 85 mg/m\\^2 Selinexor for Cycle1 Day1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '7.5'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '7.7'}, {'value': '2.1', 'groupId': 'OG003'}, {'value': '2.3', 'groupId': 'OG004', 'lowerLimit': '2.0', 'upperLimit': '7.5'}, {'value': '2.1', 'groupId': 'OG005', 'lowerLimit': '1.1', 'upperLimit': '8.0'}, {'value': '3.1', 'groupId': 'OG006', 'lowerLimit': '0.5', 'upperLimit': '7.6'}, {'value': '2.9', 'groupId': 'OG007', 'lowerLimit': '0.5', 'upperLimit': '7.7'}, {'value': '3.8', 'groupId': 'OG008', 'lowerLimit': '2.0', 'upperLimit': '7.8'}, {'value': '3.1', 'groupId': 'OG009', 'lowerLimit': '1.0', 'upperLimit': '4.3'}, {'value': '3.9', 'groupId': 'OG010', 'lowerLimit': '2.1', 'upperLimit': '4.2'}, {'value': '4.2', 'groupId': 'OG011', 'lowerLimit': '2.1', 'upperLimit': '8.0'}, {'value': '3.0', 'groupId': 'OG012', 'lowerLimit': '1.0', 'upperLimit': '4.1'}, {'value': '3.8', 'groupId': 'OG013', 'lowerLimit': '1.1', 'upperLimit': '4.0'}, {'value': '3.1', 'groupId': 'OG014', 'lowerLimit': '2.2', 'upperLimit': '4.2'}, {'value': '2.0', 'groupId': 'OG015', 'lowerLimit': '0.6', 'upperLimit': '7.5'}, {'value': '8.0', 'groupId': 'OG016'}, {'value': '3.9', 'groupId': 'OG017', 'lowerLimit': '3.8', 'upperLimit': '4.0'}, {'value': '3.9', 'groupId': 'OG018', 'lowerLimit': '3.8', 'upperLimit': '3.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes', 'description': 'Tmax was defined as time of first observation of Cmax, taken directly from the plasma concentration data.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "PK population consisted of all participants who received selinexor, and had evaluable PK for at least one dosing occasion. Data for the PK parameters were planned and analyzed based on doses and full range data was not evaluable for arms with single participant. Here, 'Overall number of participants analyzed' signifies participants with available data for the outcome measure."}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration Time Curve From the Time of Dosing to Time in Plasma (AUC0-t) of Selinexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '4', 'groupId': 'OG014'}, {'value': '7', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}, {'value': '2', 'groupId': 'OG017'}, {'value': '3', 'groupId': 'OG018'}]}], 'groups': [{'id': 'OG000', 'title': 'Selinexor Dose: 3 mg/m^2', 'description': 'Participants received 3 mg/m\\^2 of selinexor for Cycle1 Day1.'}, {'id': 'OG001', 'title': 'Selinexor Dose: 6 mg/m^2', 'description': 'Participants received single oral dose of 6 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG002', 'title': 'Selinexor Dose: 12 mg/m^2', 'description': 'Participants received single oral dose of 12 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG003', 'title': 'Selinexor Dose: 16.8 mg/m^2', 'description': 'Participants received single oral dose of 16.8 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG004', 'title': 'Selinexor Dose: 20 mg/m^2', 'description': 'Participants received single oral dose of 20 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG005', 'title': 'Selinexor Dose: 23 mg/m^2', 'description': 'Participants received single oral dose of 23 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG006', 'title': 'Selinexor Dose: 28 mg/m^2', 'description': 'Participants received single oral dose of 28 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG007', 'title': 'Selinexor Dose: 30 mg/m^2', 'description': 'Participants received single oral dose of 30 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG008', 'title': 'Selinexor Dose: 35 mg/m^2', 'description': 'Participants received single oral dose of 35 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG009', 'title': 'Selinexor Dose: 39 mg/m^2', 'description': 'Participants received single oral dose of 39 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG010', 'title': 'Selinexor Dose: 40 mg/m^2', 'description': 'Participants received single oral dose of 40 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG011', 'title': 'Selinexor Dose: 45 mg/m^2', 'description': 'Participants received single oral dose of 45 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG012', 'title': 'Selinexor Dose: 50 mg/m^2', 'description': 'Participants received single oral dose of 50 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG013', 'title': 'Selinexor Dose: 55 mg/m^2', 'description': 'Participants received single oral dose of 55 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG014', 'title': 'Selinexor Dose: 58 mg/m^2', 'description': 'Participants received single oral dose of 58 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG015', 'title': 'Selinexor Dose: 65 mg/m^2', 'description': 'Participants received single oral dose of 65 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG016', 'title': 'Selinexor Dose: 70 mg/m^2', 'description': 'Participants received single oral dose of 70 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG017', 'title': 'Selinexor Dose: 80 mg/m^2', 'description': 'Participants received single oral dose of 80 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG018', 'title': 'Selinexor Dose: 85 mg/m^2', 'description': 'Participants received single oral dose of 85 mg/m\\^2 Selinexor for Cycle1 Day1.'}], 'classes': [{'categories': [{'measurements': [{'value': '333', 'groupId': 'OG000'}, {'value': '707', 'spread': '13.6', 'groupId': 'OG001'}, {'value': '1578', 'spread': '21.0', 'groupId': 'OG002'}, {'value': '1369', 'groupId': 'OG003'}, {'value': '2446', 'spread': '23.3', 'groupId': 'OG004'}, {'value': '3387', 'spread': '17.7', 'groupId': 'OG005'}, {'value': '3106', 'spread': '31', 'groupId': 'OG006'}, {'value': '3861', 'spread': '16.6', 'groupId': 'OG007'}, {'value': '3691', 'spread': '25.0', 'groupId': 'OG008'}, {'value': '4885', 'spread': '15.3', 'groupId': 'OG009'}, {'value': '5255', 'spread': '24.4', 'groupId': 'OG010'}, {'value': '4390', 'spread': '24.9', 'groupId': 'OG011'}, {'value': '5490', 'spread': '3.1', 'groupId': 'OG012'}, {'value': '5803', 'spread': '23.5', 'groupId': 'OG013'}, {'value': '5888', 'spread': '18.9', 'groupId': 'OG014'}, {'value': '8482', 'spread': '44.8', 'groupId': 'OG015'}, {'value': '7210', 'groupId': 'OG016'}, {'value': '9838', 'spread': '12.7', 'groupId': 'OG017'}, {'value': '11485', 'spread': '20.1', 'groupId': 'OG018'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes', 'description': 'AUC0-t was defined as area under the concentration-time curve from time zero to the last non-zero concentration.', 'unitOfMeasure': 'nanogram hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population consisted of all participants who received selinexor, and had evaluable PK for at least one dosing occasion. Data for the PK parameters were planned and analyzed based on doses and % coefficient of variation was not evaluable for arms with single participant. Here, 'Overall number of participants analyzed' signifies participants with available data for the outcome measure."}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of Selinexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '5', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}, {'value': '2', 'groupId': 'OG018'}]}], 'groups': [{'id': 'OG000', 'title': 'Selinexor Dose: 3 mg/m^2', 'description': 'Participants received 3 mg/m\\^2 of selinexor for Cycle1 Day1.'}, {'id': 'OG001', 'title': 'Selinexor Dose: 6 mg/m^2', 'description': 'Participants received single oral dose of 6 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG002', 'title': 'Selinexor Dose: 12 mg/m^2', 'description': 'Participants received single oral dose of 12 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG003', 'title': 'Selinexor Dose: 16.8 mg/m^2', 'description': 'Participants received single oral dose of 16.8 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG004', 'title': 'Selinexor Dose: 20 mg/m^2', 'description': 'Participants received single oral dose of 20 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG005', 'title': 'Selinexor Dose: 23 mg/m^2', 'description': 'Participants received single oral dose of 23 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG006', 'title': 'Selinexor Dose: 28 mg/m^2', 'description': 'Participants received single oral dose of 28 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG007', 'title': 'Selinexor Dose: 30 mg/m^2', 'description': 'Participants received single oral dose of 30 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG008', 'title': 'Selinexor Dose: 35 mg/m^2', 'description': 'Participants received single oral dose of 35 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG009', 'title': 'Selinexor Dose: 39 mg/m^2', 'description': 'Participants received single oral dose of 39 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG010', 'title': 'Selinexor Dose: 40 mg/m^2', 'description': 'Participants received single oral dose of 40 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG011', 'title': 'Selinexor Dose: 45 mg/m^2', 'description': 'Participants received single oral dose of 45 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG012', 'title': 'Selinexor Dose: 50 mg/m^2', 'description': 'Participants received single oral dose of 50 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG013', 'title': 'Selinexor Dose: 55 mg/m^2', 'description': 'Participants received single oral dose of 55 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG014', 'title': 'Selinexor Dose: 58 mg/m^2', 'description': 'Participants received single oral dose of 58 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG015', 'title': 'Selinexor Dose: 65 mg/m^2', 'description': 'Participants received single oral dose of 65 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG016', 'title': 'Selinexor Dose: 70 mg/m^2', 'description': 'Participants received single oral dose of 70 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG017', 'title': 'Selinexor Dose: 80 mg/m^2', 'description': 'Participants received single oral dose of 80 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG018', 'title': 'Selinexor Dose: 85 mg/m^2', 'description': 'Participants received single oral dose of 85 mg/m\\^2 Selinexor for Cycle1 Day1.'}], 'classes': [{'categories': [{'measurements': [{'value': '355', 'groupId': 'OG000'}, {'value': '808', 'spread': '5.2', 'groupId': 'OG001'}, {'value': '1613', 'spread': '21.4', 'groupId': 'OG002'}, {'value': '1455', 'groupId': 'OG003'}, {'value': '2269', 'spread': '27.2', 'groupId': 'OG004'}, {'value': '3332', 'spread': '17.3', 'groupId': 'OG005'}, {'value': '3936', 'groupId': 'OG006'}, {'value': '3961', 'spread': '12.1', 'groupId': 'OG007'}, {'value': '4585', 'spread': '18.2', 'groupId': 'OG008'}, {'value': '5014', 'spread': '18.0', 'groupId': 'OG009'}, {'value': '5294', 'spread': '24.0', 'groupId': 'OG010'}, {'value': '3395', 'groupId': 'OG011'}, {'value': '5688', 'spread': '0.6', 'groupId': 'OG012'}, {'value': '5894', 'spread': '24.8', 'groupId': 'OG013'}, {'value': '6567', 'spread': '12.8', 'groupId': 'OG014'}, {'value': '10265', 'spread': '31.4', 'groupId': 'OG015'}, {'value': '9025', 'groupId': 'OG017'}, {'value': '11830', 'spread': '20.1', 'groupId': 'OG018'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes', 'description': 'AUC0-inf was defined as area under the concentration-time curve from time zero to infinity (extrapolated). It was calculated as AUC0-t + Ct/kel, where: Ct = the last observed non-zero concentration and Kel = elimination rate constant.', 'unitOfMeasure': 'nanogram hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population consisted of all participants who received selinexor, and had evaluable PK for at least one dosing occasion. Data for the PK parameters were planned and analyzed based on doses and % coefficient of variation was not evaluable for arms with single participant. Here, 'Overall number of participants analyzed' signifies participants with available data for the outcome measure."}, {'type': 'SECONDARY', 'title': 'Elimination Half-Life (t1/2) of Selinexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '5', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}, {'value': '2', 'groupId': 'OG018'}]}], 'groups': [{'id': 'OG000', 'title': 'Selinexor Dose: 3 mg/m^2', 'description': 'Participants received 3 mg/m\\^2 of selinexor for Cycle1 Day1.'}, {'id': 'OG001', 'title': 'Selinexor Dose: 6 mg/m^2', 'description': 'Participants received single oral dose of 6 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG002', 'title': 'Selinexor Dose: 12 mg/m^2', 'description': 'Participants received single oral dose of 12 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG003', 'title': 'Selinexor Dose: 16.8 mg/m^2', 'description': 'Participants received single oral dose of 16.8 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG004', 'title': 'Selinexor Dose: 20 mg/m^2', 'description': 'Participants received single oral dose of 20 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG005', 'title': 'Selinexor Dose: 23 mg/m^2', 'description': 'Participants received single oral dose of 23 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG006', 'title': 'Selinexor Dose: 28 mg/m^2', 'description': 'Participants received single oral dose of 28 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG007', 'title': 'Selinexor Dose: 30 mg/m^2', 'description': 'Participants received single oral dose of 30 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG008', 'title': 'Selinexor Dose: 35 mg/m^2', 'description': 'Participants received single oral dose of 35 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG009', 'title': 'Selinexor Dose: 39 mg/m^2', 'description': 'Participants received single oral dose of 39 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG010', 'title': 'Selinexor Dose: 40 mg/m^2', 'description': 'Participants received single oral dose of 40 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG011', 'title': 'Selinexor Dose: 45 mg/m^2', 'description': 'Participants received single oral dose of 45 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG012', 'title': 'Selinexor Dose: 50 mg/m^2', 'description': 'Participants received single oral dose of 50 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG013', 'title': 'Selinexor Dose: 55 mg/m^2', 'description': 'Participants received single oral dose of 55 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG014', 'title': 'Selinexor Dose: 58 mg/m^2', 'description': 'Participants received single oral dose of 58 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG015', 'title': 'Selinexor Dose: 65 mg/m^2', 'description': 'Participants received single oral dose of 65 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG016', 'title': 'Selinexor Dose: 70 mg/m^2', 'description': 'Participants received single oral dose of 70 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG017', 'title': 'Selinexor Dose: 80 mg/m^2', 'description': 'Participants received single oral dose of 80 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG018', 'title': 'Selinexor Dose: 85 mg/m^2', 'description': 'Participants received single oral dose of 85 mg/m\\^2 Selinexor for Cycle1 Day1.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '6.4'}, {'value': '5.0', 'groupId': 'OG002', 'lowerLimit': '4.1', 'upperLimit': '7.8'}, {'value': '5.7', 'groupId': 'OG003'}, {'value': '5.6', 'groupId': 'OG004', 'lowerLimit': '4.2', 'upperLimit': '7.5'}, {'value': '5.8', 'groupId': 'OG005', 'lowerLimit': '5.7', 'upperLimit': '6.4'}, {'value': '5.7', 'groupId': 'OG006'}, {'value': '6.5', 'groupId': 'OG007', 'lowerLimit': '4.1', 'upperLimit': '7.9'}, {'value': '6.0', 'groupId': 'OG008', 'lowerLimit': '4.0', 'upperLimit': '7.0'}, {'value': '5.9', 'groupId': 'OG009', 'lowerLimit': '3.5', 'upperLimit': '6.2'}, {'value': '6.9', 'groupId': 'OG010', 'lowerLimit': '5.4', 'upperLimit': '7.2'}, {'value': '7.3', 'groupId': 'OG011'}, {'value': '7.3', 'groupId': 'OG012', 'lowerLimit': '7.1', 'upperLimit': '7.5'}, {'value': '6.2', 'groupId': 'OG013', 'lowerLimit': '5.0', 'upperLimit': '10.1'}, {'value': '6.5', 'groupId': 'OG014', 'lowerLimit': '5.6', 'upperLimit': '7.1'}, {'value': '6.9', 'groupId': 'OG015', 'lowerLimit': '5.5', 'upperLimit': '9.3'}, {'value': '5.7', 'groupId': 'OG017'}, {'value': '5.3', 'groupId': 'OG018', 'lowerLimit': '4.6', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes', 'description': 't1/2 was defined as elimination half-life, it was calculated as ln(2)/kel, where In = natural logarithm and kel = elimination rate constant.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "PK population consisted of all participants who received selinexor, and had evaluable PK for at least one dosing occasion. Data for the PK parameters were planned and analyzed based on doses and full range was not evaluable for arms with single participant. Here, 'Overall number of participants analyzed' signifies participants with available data for the outcome measure."}, {'type': 'SECONDARY', 'title': 'Apparent Total Body Clearance (CL/F) of Selinexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '5', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}, {'value': '2', 'groupId': 'OG018'}]}], 'groups': [{'id': 'OG000', 'title': 'Selinexor Dose: 3 mg/m^2', 'description': 'Participants received 3 mg/m\\^2 of selinexor for Cycle1 Day1.'}, {'id': 'OG001', 'title': 'Selinexor Dose: 6 mg/m^2', 'description': 'Participants received single oral dose of 6 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG002', 'title': 'Selinexor Dose: 12 mg/m^2', 'description': 'Participants received single oral dose of 12 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG003', 'title': 'Selinexor Dose: 16.8 mg/m^2', 'description': 'Participants received single oral dose of 16.8 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG004', 'title': 'Selinexor Dose: 20 mg/m^2', 'description': 'Participants received single oral dose of 20 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG005', 'title': 'Selinexor Dose: 23 mg/m^2', 'description': 'Participants received single oral dose of 23 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG006', 'title': 'Selinexor Dose: 28 mg/m^2', 'description': 'Participants received single oral dose of 28 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG007', 'title': 'Selinexor Dose: 30 mg/m^2', 'description': 'Participants received single oral dose of 30 mg/m\\^2 Selinexor for Cycle1Day1.'}, {'id': 'OG008', 'title': 'Selinexor Dose: 35 mg/m^2', 'description': 'Participants received single oral dose of 35 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG009', 'title': 'Selinexor Dose: 39 mg/m^2', 'description': 'Participants received single oral dose of 39 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG010', 'title': 'Selinexor Dose: 40 mg/m^2', 'description': 'Participants received single oral dose of 40 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG011', 'title': 'Selinexor Dose: 45 mg/m^2', 'description': 'Participants received single oral dose of 45 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG012', 'title': 'Selinexor Dose: 50 mg/m^2', 'description': 'Participants received single oral dose of 50 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG013', 'title': 'Selinexor Dose: 55 mg/m^2', 'description': 'Participants received single oral dose of 55 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG014', 'title': 'Selinexor Dose: 58 mg/m^2', 'description': 'Participants received single oral dose of 58 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG015', 'title': 'Selinexor Dose: 65 mg/m^2', 'description': 'Participants received single oral dose of 65 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG016', 'title': 'Selinexor Dose: 70 mg/m^2', 'description': 'Participants received single oral dose of 70 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG017', 'title': 'Selinexor Dose: 80 mg/m^2', 'description': 'Participants received single oral dose of 80 mg/m\\^2 Selinexor for Cycle1 Day1.'}, {'id': 'OG018', 'title': 'Selinexor Dose: 85 mg/m^2', 'description': 'Participants received single oral dose of 85 mg/m\\^2 Selinexor for Cycle1 Day1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.20', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '7.9', 'groupId': 'OG001'}, {'value': '0.19', 'spread': '16', 'groupId': 'OG002'}, {'value': '0.20', 'groupId': 'OG003'}, {'value': '0.19', 'spread': '27', 'groupId': 'OG004'}, {'value': '0.19', 'spread': '26.1', 'groupId': 'OG005'}, {'value': '0.18', 'groupId': 'OG006'}, {'value': '0.17', 'spread': '16.8', 'groupId': 'OG007'}, {'value': '0.20', 'spread': '26.7', 'groupId': 'OG008'}, {'value': '0.20', 'spread': '12.5', 'groupId': 'OG009'}, {'value': '0.19', 'spread': '24.4', 'groupId': 'OG010'}, {'value': '0.27', 'groupId': 'OG011'}, {'value': '0.18', 'spread': '10.6', 'groupId': 'OG012'}, {'value': '0.20', 'spread': '17.1', 'groupId': 'OG013'}, {'value': '0.20', 'spread': '17.0', 'groupId': 'OG014'}, {'value': '0.15', 'spread': '32.7', 'groupId': 'OG015'}, {'value': '0.22', 'groupId': 'OG017'}, {'value': '0.18', 'spread': '4.1', 'groupId': 'OG018'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes', 'description': 'CL/F was calculated as Dose/AUC0-inf, uncorrected for fraction absorbed; reported normalized by participant body weight (kilogram).', 'unitOfMeasure': 'liter per hour per kilogram', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population consisted of all participants who received selinexor, and had evaluable PK for at least one dosing occasion. Data for the PK parameters were planned and analyzed based on doses and % coefficient of variation was not evaluable for arms with single participant. Here, 'Overall number of participants analyzed' signifies participants with available data for the outcome measure."}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution of Selinexor (Vd/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '5', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}, {'value': '2', 'groupId': 'OG018'}]}], 'groups': [{'id': 'OG000', 'title': 'Selinexor Dose: 3 Milligram Per Square Meter (mg/m2)', 'description': 'Participants received 3 mg/m2 of selinexor for Cycle1Day1.'}, {'id': 'OG001', 'title': 'Selinexor Dose: 6 mg/m2', 'description': 'Participants received single oral dose of 6 mg/m2 Selinexor for Cycle1Day1.'}, {'id': 'OG002', 'title': 'Selinexor Dose: 12 mg/m2', 'description': 'Participants received single oral dose of 12 mg/m2 Selinexor for Cycle1Day1.'}, {'id': 'OG003', 'title': 'Selinexor Dose: 16.8 mg/m2', 'description': 'Participants received single oral dose of 16.8 mg/m2 Selinexor for Cycle1Day1.'}, {'id': 'OG004', 'title': 'Selinexor Dose: 20 mg/m2', 'description': 'Participants received single oral dose of 20 mg/m2 Selinexor for Cycle1Day1.'}, {'id': 'OG005', 'title': 'Selinexor Dose: 23 mg/m2', 'description': 'Participants received single oral dose of 23 mg/m2 Selinexor for Cycle1Day1.'}, {'id': 'OG006', 'title': 'Selinexor Dose: 28 mg/m2', 'description': 'Participants received single oral dose of 28 mg/m2 Selinexor for Cycle1Day1.'}, {'id': 'OG007', 'title': 'Selinexor Dose: 30 mg/m2', 'description': 'Participants received single oral dose of 30 mg/m2 Selinexor for Cycle1Day1.'}, {'id': 'OG008', 'title': 'Selinexor Dose: 35 mg/m2', 'description': 'Participants received single oral dose of 35 mg/m2 Selinexor for Cycle1Day1.'}, {'id': 'OG009', 'title': 'Selinexor Dose: 39 mg/m2', 'description': 'Participants received single oral dose of 39 mg/m2 Selinexor for Cycle1Day1.'}, {'id': 'OG010', 'title': 'Selinexor Dose: 40 mg/m2', 'description': 'Participants received single oral dose of 40 mg/m2 Selinexor for Cycle1Day1.'}, {'id': 'OG011', 'title': 'Selinexor Dose: 45 mg/m2', 'description': 'Participants received single oral dose of 45 mg/m2 Selinexor for Cycle1Day1.'}, {'id': 'OG012', 'title': 'Selinexor Dose: 50 mg/m2', 'description': 'Participants received single oral dose of 50 mg/m2 Selinexor for Cycle1Day1.'}, {'id': 'OG013', 'title': 'Selinexor Dose: 55 mg/m2', 'description': 'Participants received single oral dose of 55 mg/m2 Selinexor for Cycle1Day1.'}, {'id': 'OG014', 'title': 'Selinexor Dose: 58 mg/m2', 'description': 'Participants received single oral dose of 58 mg/m2 Selinexor for Cycle1Day1.'}, {'id': 'OG015', 'title': 'Selinexor Dose: 65 mg/m2', 'description': 'Participants received single oral dose of 65 mg/m2 Selinexor for Cycle1Day1.'}, {'id': 'OG016', 'title': 'Selinexor Dose: 70 mg/m2', 'description': 'Participants received single oral dose of 70 mg/m2 Selinexor for Cycle1Day1.'}, {'id': 'OG017', 'title': 'Selinexor Dose: 80 mg/m2', 'description': 'Participants received single oral dose of 80 mg/m2 Selinexor for Cycle1Day1.'}, {'id': 'OG018', 'title': 'Selinexor Dose: 85 mg/m2', 'description': 'Participants received single oral dose of 85 mg/m2 Selinexor for Cycle1Day1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '12.5', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '22.5', 'groupId': 'OG002'}, {'value': '1.6', 'groupId': 'OG003'}, {'value': '1.6', 'spread': '20.9', 'groupId': 'OG004'}, {'value': '1.6', 'spread': '21.2', 'groupId': 'OG005'}, {'value': '1.5', 'groupId': 'OG006'}, {'value': '1.6', 'spread': '6.6', 'groupId': 'OG007'}, {'value': '1.6', 'spread': '26.6', 'groupId': 'OG008'}, {'value': '1.5', 'spread': '26.1', 'groupId': 'OG009'}, {'value': '1.9', 'spread': '31.1', 'groupId': 'OG010'}, {'value': '2.8', 'groupId': 'OG011'}, {'value': '1.9', 'spread': '14.3', 'groupId': 'OG012'}, {'value': '1.9', 'spread': '24.7', 'groupId': 'OG013'}, {'value': '1.8', 'spread': '15.4', 'groupId': 'OG014'}, {'value': '1.5', 'spread': '31.8', 'groupId': 'OG015'}, {'value': '1.8', 'groupId': 'OG017'}, {'value': '1.4', 'spread': '22.7', 'groupId': 'OG018'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes', 'description': 'Vd/F was calculated as Dose/(kel \\* AUC0-inf), uncorrected for fraction absorbed; reported normalized by participant body weight (kilogram).', 'unitOfMeasure': 'liter per kilogram', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population consisted of all participants who received selinexor, and had evaluable PK for at least one dosing occasion. Data for the PK parameters were planned and analyzed based on doses and % coefficient of variation was not evaluable for arms with single participant. Here, 'Overall number of participants analyzed' signifies participants with available data for the outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Best Overall Response (BOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Colorectal Cancer)', 'description': 'Participants with colorectal cancer with liver metastasis received oral selinexor as a single agent in eight schedules- Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW(Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 6: ≥20 mg/m\\^2 BIW (Days 1 and 4) after 500 mg (Cycle 1, Week 1) to 1000 mg (Cycle 1, Week 2 onwards) acetaminophen (given 1 hour prior to each selinexor dose) up to 8 doses/cycle(28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Arm B (Gynecological Cancer)', 'description': 'Participants with gynecological cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Arm C (Squamous Cell Cancer)', 'description': 'Participants with squamous cell cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Arm D (Castrate-resistant Prostate Cancer)', 'description': 'Participants with CRPC received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Arm E (Glioblastoma Multiforme)', 'description': 'Participants with GBM received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Arm F (Melanoma)', 'description': 'Participants with melanoma received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Arm G (Other Solid Tumors)', 'description': 'Participants with other solid tumors received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}], 'classes': [{'title': 'Complete Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Partial Response', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}]}]}, {'title': 'Progression (Objective)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}]}, {'title': 'Progressive Disease due to symptomatic deterioration', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Not Evaluable', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to maximum duration of 45 months', 'description': 'BOR is response recorded from start of treatment until disease progression/recurrence. Best lesion response was defined by Recist Criteria V1 (for target and non-target lesions) and RANO criteria (for glioblastoma multiforme): complete response (CR)- disappearance of all target lesions. Any pathological lymph nodes (target/non target) must have reduction in short axis to less than (\\<) 10 mm; partial response (PR)- at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum longest diameter; stable disease (SD)- steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; progressive disease (PD): at least 20% increase in sum of diameters of measured lesions taking as references smallest sum of diameters recorded since treatment started. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5 mm, or appearance of one or more new lesions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population included all participants registered to the study who had either completed 1 cycle of treatment or discontinued treatment prior to completing the first cycle due to documented disease progression, death related to disease, or treatment-related toxicity. As pre-specified in the study Protocol data were not collected per dose level. The limited data available based on cancer stratification as pre-specified in the protocol is presented.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Colorectal Cancer)', 'description': 'Participants with colorectal cancer with liver metastasis received oral selinexor as a single agent in eight schedules- Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW(Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 6: ≥20 mg/m\\^2 BIW (Days 1 and 4) after 500 mg (Cycle 1, Week 1) to 1000 mg (Cycle 1, Week 2 onwards) acetaminophen (given 1 hour prior to each selinexor dose) up to 8 doses/cycle(28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Arm B (Gynecological Cancer)', 'description': 'Participants with gynecological cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Arm C (Squamous Cell Cancer)', 'description': 'Participants with squamous cell cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Arm D (Castrate-resistant Prostate Cancer)', 'description': 'Participants with CRPC received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Arm E (Glioblastoma Multiforme)', 'description': 'Participants with GBM received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Arm F (Melanoma)', 'description': 'Participants with melanoma received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Arm G (Other Solid Tumors)', 'description': 'Participants with other solid tumors received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '15.0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '14.3', 'groupId': 'OG005'}, {'value': '2.2', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to maximum duration of 45 months', 'description': 'Objective response rate (ORR) was determined as percentage of participants who had either CR or PR, as defined by RECIST v1.1 (for solid tumors). CR was defined as disappearance of all target lesions. Any pathological lymph nodes (target/non target) must have reduction in short axis to \\<10 mm and PR was defined as at least 30% decrease in sum of diameters of target lesions. ORR was calculated as a proportion and included a 2 sided 95% CI using the exact (Clopper-Pearson) method.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population included all participants registered to the study who had either completed 1 cycle of treatment or discontinued treatment prior to completing the first cycle due to documented disease progression, death related to disease, or treatment-related toxicity. As pre-specified in the study Protocol data were not collected per dose level. The limited data available based on cancer stratification as pre-specified in the protocol is presented.'}, {'type': 'SECONDARY', 'title': 'Duration of Stable Disease (SD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Colorectal Cancer)', 'description': 'Participants with colorectal cancer with liver metastasis received oral selinexor as a single agent in eight schedules- Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW(Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 6: ≥20 mg/m\\^2 BIW (Days 1 and 4) after 500 mg (Cycle 1, Week 1) to 1000 mg (Cycle 1, Week 2 onwards) acetaminophen (given 1 hour prior to each selinexor dose) up to 8 doses/cycle(28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Arm B (Gynecological Cancer)', 'description': 'Participants with gynecological cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Arm C (Squamous Cell Cancer)', 'description': 'Participants with squamous cell cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Arm D (Castrate-resistant Prostate Cancer)', 'description': 'Participants with CRPC received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Arm E (Glioblastoma Multiforme)', 'description': 'Participants with GBM received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Arm F (Melanoma)', 'description': 'Participants with melanoma received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Arm G (Other Solid Tumors)', 'description': 'Participants with other solid tumors received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000', 'lowerLimit': '52', 'upperLimit': '59'}, {'value': '119', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '310'}, {'value': '52', 'groupId': 'OG002', 'lowerLimit': '46', 'upperLimit': '79'}, {'value': '133', 'groupId': 'OG003', 'lowerLimit': '53', 'upperLimit': '484'}, {'value': '43', 'groupId': 'OG004', 'lowerLimit': '38', 'upperLimit': '55'}, {'value': '52', 'groupId': 'OG005', 'lowerLimit': '22', 'upperLimit': '539'}, {'value': '134', 'groupId': 'OG006', 'lowerLimit': '53', 'upperLimit': '267'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug administration to first documented evidence of disease recurrence or progression (maximum duration of 45 months)', 'description': 'Duration of stable disease was defined as the time from the date of first dose to first documented radiologic evidence of disease recurrence or progression, as defined by RECIST v1.1 (for solid tumors) or RANO criteria (for GBM and AnaA).', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population included all participants registered to the study who had either completed 1 cycle of treatment or discontinued treatment prior to completing the first cycle due to documented disease progression, death related to disease, or treatment-related toxicity. As pre-specified in the study Protocol data were not collected per dose level. The limited data available based on cancer stratification as pre-specified in the protocol is presented.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Colorectal Cancer)', 'description': 'Participants with colorectal cancer with liver metastasis received oral selinexor as a single agent in eight schedules- Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW(Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 6: ≥20 mg/m\\^2 BIW (Days 1 and 4) after 500 mg (Cycle 1, Week 1) to 1000 mg (Cycle 1, Week 2 onwards) acetaminophen (given 1 hour prior to each selinexor dose) up to 8 doses/cycle(28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Arm B (Gynecological Cancer)', 'description': 'Participants with gynecological cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Arm C (Squamous Cell Cancer)', 'description': 'Participants with squamous cell cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Arm D (Castrate-resistant Prostate Cancer)', 'description': 'Participants with CRPC received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Arm E (Glioblastoma Multiforme)', 'description': 'Participants with GBM received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Arm F (Melanoma)', 'description': 'Participants with melanoma received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Arm G (Other Solid Tumors)', 'description': 'Participants with other solid tumors received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000', 'lowerLimit': '52', 'upperLimit': '59'}, {'value': '119', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '310'}, {'value': '52', 'groupId': 'OG002', 'lowerLimit': '44', 'upperLimit': '79'}, {'value': '127', 'groupId': 'OG003', 'lowerLimit': '53', 'upperLimit': '322'}, {'value': '41', 'groupId': 'OG004', 'lowerLimit': '38', 'upperLimit': '55'}, {'value': '52', 'groupId': 'OG005', 'lowerLimit': '22', 'upperLimit': '539'}, {'value': '88', 'groupId': 'OG006', 'lowerLimit': '53', 'upperLimit': '234'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study drug administration until PD or discontinuation from the study or death (maximum duration of 45 months)', 'description': 'Progression-free survival was calculated from the date of first dose of study treatment to first documented evidence of disease recurrence or progression or death due to any cause. Patients who are last known to be alive and without evidence of progression will be censored at time of last evaluable disease assessment. If date of progression or death occurred after more than 1 missed disease assessment interval, patients are censored at the time of last evaluable disease assessment prior to the missed assessment. Progressive disease was defined as at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded since the treatment started. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions also constituted progressive disease.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population included all participants registered to the study who had either completed 1 cycle of treatment or discontinued treatment prior to completing the first cycle due to documented disease progression, death related to disease, or treatment-related toxicity. As pre-specified in the study Protocol data were not collected per dose level. The limited data available based on cancer stratification as pre-specified in the protocol is presented.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Colorectal Cancer)', 'description': 'Participants with colorectal cancer with liver metastasis received oral selinexor as a single agent in eight schedules- Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW(Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 6: ≥20 mg/m\\^2 BIW (Days 1 and 4) after 500 mg (Cycle 1, Week 1) to 1000 mg (Cycle 1, Week 2 onwards) acetaminophen (given 1 hour prior to each selinexor dose) up to 8 doses/cycle(28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Arm B (Gynecological Cancer)', 'description': 'Participants with gynecological cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Arm C (Squamous Cell Cancer)', 'description': 'Participants with squamous cell cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Arm D (Castrate-resistant Prostate Cancer)', 'description': 'Participants with CRPC received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Arm E (Glioblastoma Multiforme)', 'description': 'Participants with GBM received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Arm F (Melanoma)', 'description': 'Participants with melanoma received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'OG006', 'title': 'Arm G (Other Solid Tumors)', 'description': 'Participants with other solid tumors received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000', 'lowerLimit': '102', 'upperLimit': '532'}, {'value': '491', 'comment': "Here, 'NA' signifies that data was not evaluable for specific arms as the model can't estimate the data when the death events during the study was less than 50%.", 'groupId': 'OG001', 'lowerLimit': '167', 'upperLimit': 'NA'}, {'value': '161', 'groupId': 'OG002', 'lowerLimit': '62', 'upperLimit': '460'}, {'value': '354', 'comment': "Here, 'NA' signifies that data was not evaluable for specific arms as the model can't estimate the data when the death events during the study was less than 50%.", 'groupId': 'OG003', 'lowerLimit': '322', 'upperLimit': 'NA'}, {'value': '103', 'groupId': 'OG004', 'lowerLimit': '38', 'upperLimit': '152'}, {'value': 'NA', 'comment': "Here, 'NA' signifies that data was not evaluable for specific arms as the model can't estimate the data when the death events during the study was less than 50%.", 'groupId': 'OG005', 'lowerLimit': '125', 'upperLimit': 'NA'}, {'value': '290', 'comment': "Here, 'NA' signifies that data was not evaluable for specific arms as the model can't estimate the data when the death events during the study was less than 50%.", 'groupId': 'OG006', 'lowerLimit': '263', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug administration to date of death (maximum duration of 45 months)', 'description': 'OS was calculated from the date of first dose to date of death. Participants who were still alive prior to the data cutoff for final efficacy analysis, or who dropout prior to study end, were censored at the day they were last known to be alive. The OS was calculated using the Kaplan-Meier method.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population included all participants registered to the study who had either completed 1 cycle of treatment or discontinued treatment prior to completing the first cycle due to documented disease progression, death related to disease, or treatment-related toxicity. As pre-specified in the study Protocol data were not collected per dose level. The limited data available based on cancer stratification as pre-specified in the protocol is presented.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A (Colorectal Cancer)', 'description': 'Participants with colorectal cancer with liver metastasis received oral selinexor as a single agent in eight schedules- Schedule 1: ≤12 milligrams per meter square (mg/m\\^2) 3 times weekly (TIW) during Weeks 1 and 3, twice weekly (BIW) during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW(Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 6: ≥20 mg/m\\^2 BIW (Days 1 and 4) after 500 mg (Cycle 1, Week 1) to 1000 mg (Cycle 1, Week 2 onwards) acetaminophen (given 1 hour prior to each selinexor dose) up to 8 doses/cycle(28 days/cycle); Schedule 7: ≥50 mg/m\\^2 once weekly (QW) up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'FG001', 'title': 'Arm B (Gynecological Cancer)', 'description': 'Participants with gynecological cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'FG002', 'title': 'Arm C (Squamous Cell Cancer)', 'description': 'Participants with squamous cell cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'FG003', 'title': 'Arm D (Castrate-resistant Prostate Cancer)', 'description': 'Participants with CRPC received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'FG004', 'title': 'Arm E (Glioblastoma Multiforme)', 'description': 'Participants with GBM received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'FG005', 'title': 'Arm F (Melanoma)', 'description': 'Participants with melanoma received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'FG006', 'title': 'Arm G (Other Solid Tumors)', 'description': 'Participants with other solid tumors received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '21'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '15'}, {'groupId': 'FG006', 'numSubjects': '47'}]}, {'type': 'Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '21'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '15'}, {'groupId': 'FG006', 'numSubjects': '47'}]}, {'type': 'Low Dose (<30 mg/m^2)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '8'}]}, {'type': 'Medium Dose (>=30 mg/m^2 and <55 mg/m^2)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '21'}]}, {'type': 'High Dose (>= 55 mg/m^2)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'comment': 'Participants who completed study treatment.', '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'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '21'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '15'}, {'groupId': 'FG006', 'numSubjects': '47'}]}], 'dropWithdraws': [{'type': 'Withdrawal by participant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '12'}]}, {'type': 'Incidence or severity of AEs', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '8'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '21'}]}, {'type': 'Non-compliance with study procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '3'}]}, {'type': 'Other treatments become available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Investigator discretion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at six centers in United States, Canada, and Denmark from 18 June 2012 and 15 March 2016.', 'preAssignmentDetails': 'A total of 192 participants were enrolled, of which 191 participants started study (1 participant reported missing malignancy), 189 participants received at least 1 dose of study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '47', 'groupId': 'BG006'}, {'value': '189', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A (Colorectal Cancer)', 'description': 'Participants with colorectal cancer with liver metastasis received oral selinexor as a single agent in eight schedules- Schedule 1: ≤12 milligrams per meter square (mg/m\\^2) 3 times weekly (TIW) during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW(Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 6: ≥20 mg/m\\^2 BIW (Days 1 and 4) after 500 mg (Cycle 1, Week 1) to 1000 mg (Cycle 1, Week 2 onwards) acetaminophen (given 1 hour prior to each selinexor dose) up to 8 doses/cycle(28 days/cycle); Schedule 7: ≥50 mg/m\\^2 once weekly (QW) up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'BG001', 'title': 'Arm B (Gynecological Cancer)', 'description': 'Participants with gynecological cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'BG002', 'title': 'Arm C (Squamous Cell Cancer)', 'description': 'Participants with squamous cell cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'BG003', 'title': 'Arm D (Castrate-resistant Prostate Cancer)', 'description': 'Participants with CRPC received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'BG004', 'title': 'Arm E (Glioblastoma Multiforme)', 'description': 'Participants with GBM received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'BG005', 'title': 'Arm F (Melanoma)', 'description': 'Participants with melanoma received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'BG006', 'title': 'Arm G (Other Solid Tumors)', 'description': 'Participants with other solid tumors received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.8', 'spread': '11.35', 'groupId': 'BG000'}, {'value': '55.0', 'spread': '12.54', 'groupId': 'BG001'}, {'value': '59.2', 'spread': '7.39', 'groupId': 'BG002'}, {'value': '68.7', 'spread': '7.69', 'groupId': 'BG003'}, {'value': '56.0', 'spread': '14.94', 'groupId': 'BG004'}, {'value': '67.7', 'spread': '11.04', 'groupId': 'BG005'}, {'value': '57.7', 'spread': '12.67', 'groupId': 'BG006'}, {'value': '60.2', 'spread': '11.82', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}, {'value': '75', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '33', 'groupId': 'BG006'}, {'value': '114', 'groupId': 'BG007'}]}]}], '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': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '22', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}, {'value': '157', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Population included all participants who received at least one dose of selinexor. As pre-specified in the study Protocol data were not collected per dose level. The limited data available based on cancer stratification as pre-specified in the protocol is presented.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2016-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-24', 'studyFirstSubmitDate': '2012-05-16', 'resultsFirstSubmitDate': '2021-02-16', 'studyFirstSubmitQcDate': '2012-05-25', 'lastUpdatePostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-06', 'studyFirstPostDateStruct': {'date': '2012-05-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From start of study drug administration to 30 days after last dose of study treatment (maximum duration of 45 months)', 'description': 'An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAE was defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) was defined as an AE that meets one or more of the mentioned criteria; is fatal, life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events. Number of participants with TEAEs and TESAEs were reported.'}, {'measure': 'Number of Participants With Treatment-related Treatment-emergent Adverse Events', 'timeFrame': 'From start of study drug administration to 30 days after last dose of study treatment (maximum duration of 45 months)', 'description': 'An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAE was defined as an adverse event with an onset that occurs after receiving study drug. A treatment-related AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product; the event had a causal relationship with the treatment or usage.'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) Greater Than or Equal to Grade 3, Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03', 'timeFrame': 'From start of study drug administration to 30 days after last dose of study treatment (maximum duration of 45 months)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. A treatment related AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event had a causal relationship with the treatment or usage.'}, {'measure': 'Number of Participants Who Experienced Dose Limiting Toxicity (DLT)', 'timeFrame': 'Cycle 1 only (28-day cycle)', 'description': 'Evaluation of DLTs was only conducted in participants who participated in the Dose-escalation Phase. A DLT was defined as any of the following, considered possibly related to drug administration, occurring in the first 28 days (or 21 days for participants on Schedule 8) at the target dose (ie, for Schedule 2 this meant the first 4 weeks after the 12 mg/m2 run-in week): Missed selinexor doses due to drug-related toxicities, discontinuation of a participant due to a toxicity that was at least possibly related to study drug before completing Cycle 1.'}, {'measure': 'Recommended Phase 2 Dose (RP2D)', 'timeFrame': 'From start of study drug administration to 30 days after last dose of study treatment (maximum duration of 45 months)', 'description': 'The RP2D was the maximum tolerated dose (MTD) or less. MTD was defined as the next lower dose level below the one in which \\>1 of 3 participants or ≥2 of 6 participants experienced DLT, provided that dose level was ≤25 percent (%) lower than the highest (intolerable) dose tested. If the projected MTD was \\>25% lower than the highest dose tested, then an additional cohort of ≥3 participants was added at a dose that was intermediate between the intolerable dose and the next lower dose.'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) of Selinexor', 'timeFrame': 'Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes', 'description': 'Cmax was defined as maximum observed concentration, taken directly from the plasma concentration data.'}, {'measure': 'Time of Maximum Observed Concentration in Plasma (Tmax) of Selinexor', 'timeFrame': 'Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes', 'description': 'Tmax was defined as time of first observation of Cmax, taken directly from the plasma concentration data.'}, {'measure': 'Area Under the Concentration Time Curve From the Time of Dosing to Time in Plasma (AUC0-t) of Selinexor', 'timeFrame': 'Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes', 'description': 'AUC0-t was defined as area under the concentration-time curve from time zero to the last non-zero concentration.'}, {'measure': 'Area Under the Concentration Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of Selinexor', 'timeFrame': 'Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes', 'description': 'AUC0-inf was defined as area under the concentration-time curve from time zero to infinity (extrapolated). It was calculated as AUC0-t + Ct/kel, where: Ct = the last observed non-zero concentration and Kel = elimination rate constant.'}, {'measure': 'Elimination Half-Life (t1/2) of Selinexor', 'timeFrame': 'Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes', 'description': 't1/2 was defined as elimination half-life, it was calculated as ln(2)/kel, where In = natural logarithm and kel = elimination rate constant.'}, {'measure': 'Apparent Total Body Clearance (CL/F) of Selinexor', 'timeFrame': 'Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes', 'description': 'CL/F was calculated as Dose/AUC0-inf, uncorrected for fraction absorbed; reported normalized by participant body weight (kilogram).'}, {'measure': 'Apparent Volume of Distribution of Selinexor (Vd/F)', 'timeFrame': 'Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes', 'description': 'Vd/F was calculated as Dose/(kel \\* AUC0-inf), uncorrected for fraction absorbed; reported normalized by participant body weight (kilogram).'}, {'measure': 'Number of Participants With Best Overall Response (BOR)', 'timeFrame': 'Up to maximum duration of 45 months', 'description': 'BOR is response recorded from start of treatment until disease progression/recurrence. Best lesion response was defined by Recist Criteria V1 (for target and non-target lesions) and RANO criteria (for glioblastoma multiforme): complete response (CR)- disappearance of all target lesions. Any pathological lymph nodes (target/non target) must have reduction in short axis to less than (\\<) 10 mm; partial response (PR)- at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum longest diameter; stable disease (SD)- steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; progressive disease (PD): at least 20% increase in sum of diameters of measured lesions taking as references smallest sum of diameters recorded since treatment started. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5 mm, or appearance of one or more new lesions.'}, {'measure': 'Percentage of Participants With Objective Response', 'timeFrame': 'Up to maximum duration of 45 months', 'description': 'Objective response rate (ORR) was determined as percentage of participants who had either CR or PR, as defined by RECIST v1.1 (for solid tumors). CR was defined as disappearance of all target lesions. Any pathological lymph nodes (target/non target) must have reduction in short axis to \\<10 mm and PR was defined as at least 30% decrease in sum of diameters of target lesions. ORR was calculated as a proportion and included a 2 sided 95% CI using the exact (Clopper-Pearson) method.'}, {'measure': 'Duration of Stable Disease (SD)', 'timeFrame': 'From first dose of study drug administration to first documented evidence of disease recurrence or progression (maximum duration of 45 months)', 'description': 'Duration of stable disease was defined as the time from the date of first dose to first documented radiologic evidence of disease recurrence or progression, as defined by RECIST v1.1 (for solid tumors) or RANO criteria (for GBM and AnaA).'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'From start of study drug administration until PD or discontinuation from the study or death (maximum duration of 45 months)', 'description': 'Progression-free survival was calculated from the date of first dose of study treatment to first documented evidence of disease recurrence or progression or death due to any cause. Patients who are last known to be alive and without evidence of progression will be censored at time of last evaluable disease assessment. If date of progression or death occurred after more than 1 missed disease assessment interval, patients are censored at the time of last evaluable disease assessment prior to the missed assessment. Progressive disease was defined as at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded since the treatment started. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions also constituted progressive disease.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From first dose of study drug administration to date of death (maximum duration of 45 months)', 'description': 'OS was calculated from the date of first dose to date of death. Participants who were still alive prior to the data cutoff for final efficacy analysis, or who dropout prior to study end, were censored at the day they were last known to be alive. The OS was calculated using the Kaplan-Meier method.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Selinexor', 'KPT-330', 'Squamous Cell Carcinoma', 'Glioblastoma multiforme', 'Adenocarcinoma', 'Melanoma', 'Colorectal cancer', 'Gynecological cancer', 'Castrate-resistant Prostate Cancer', 'Other solid tumors'], 'conditions': ['Solid Tumor']}, 'referencesModule': {'references': [{'pmid': '28630120', 'type': 'DERIVED', 'citation': 'Machlus KR, Wu SK, Vijey P, Soussou TS, Liu ZJ, Shacham E, Unger TJ, Kashyap T, Klebanov B, Sola-Visner M, Crochiere M, Italiano JE Jr, Landesman Y. Selinexor-induced thrombocytopenia results from inhibition of thrombopoietin signaling in early megakaryopoiesis. Blood. 2017 Aug 31;130(9):1132-1143. doi: 10.1182/blood-2016-11-752840. Epub 2017 Jun 19.'}]}, 'descriptionModule': {'briefSummary': 'Phase 1 study to evaluate the safety and tolerability of selinexor and determine the Recommended Phase 2 Dose (RP2D) of selinexor for advanced or metastatic solid tumor malignancies.', 'detailedDescription': 'This is a phase 1a and phase 1b, open-label, dose-escalation study to evaluate the safety and tolerability of selinexor and determine the RP2D in patients with solid tumor malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Dose Escalation Phase: Patients with advanced or metastatic solid tumors for which no standard therapy is available. For Schedule 6 only: patients with colorectal cancer with liver metastasis.\n\n Dose Expansion Phase: Previously treated, metastatic or advanced recurrent malignancy with 1 of the following diagnoses, which has been confirmed histologically or cytologically:\n * Up to 12 patients with metastatic colorectal cancer with a history of progression or recurrence following prior fluoropyrimidine, irinotecan and platinum containing regimens as well as bevacizumab. In addition, patients with Kras wild type tumor must have received at least one EGFR blocker.\n * Up to 6 patients with histological or cytological documentation of advanced ovarian, fallopian tube, or primary peritoneal carcinoma with a history of progression or recurrence following at least one prior platinum and one taxane based chemotherapy\n * Up to 12 patients with incurable Squamous cell cancers as follows:\n\n 1. A minimum of 4 Squamous Non-Small Cell Lung Cancer (Sq-NSCLC)\n 2. A minimum of 4 Squamous Cell Carcinomas of the Head and Neck (Sq-HNC)\n 3. Squamous Cell Carcinoma of the Cervix (SqCC) All patient with Squamous Cell Carcinomas should have a documented history of progression or recurrence following at least one prior platinum based chemotherapy or chemotherapy/radiation containing regimen\n * Up to 6 patients with castration-resistant prostate cancer (CRPC) that was pathologically confirmed as adenocarcinoma of the prostate and with evidence of metastatic disease on bone scan or other imaging. Patient must have progressive disease after at least one hormonal treatment and one cytotoxic therapy e.g. with docetaxel, mitoxantrone.\n * Up to 12 patients with unresectable metastatic melanoma whose disease progressed on at least 1 prior systemic anticancer regimen (chemotherapy, biological or immunotherapy, or targeted therapy). Enrollment to this cohort may have been stopped before reaching 12 patients once the dose-escalation portion of the study was completed.\n * Approximately 6 patients with advanced or metastatic solid tumors were to be enrolled on Schedule 8 at a starting dose of 35 mg/m\\^2 to assess general tolerability and activity of selinexor.\n2. Dose Escalation Phase: Patients have exhausted, or be deemed to not benefit from, further conventional therapy and have evidence of progressive disease on study entry.\n\nBoth Dose Escalation and Expansion Phases: There is no upper limit on the number of prior treatments provided that all inclusion criteria are met and exclusion criteria are not met. Hormone ablation therapy is considered an anticancer regimen. Radiation and surgery are not considered anticancer regimes.\n\nExclusion Criteria:\n\n1. Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤3 weeks prior to cycle 1 day 1 and mitomycin C and radioimmunotherapy 6 weeks prior to cycle 1 day 1;\n2. Except for patients with GBM/ AnaA in the Expansion Phase, patients with active CNS malignancy are excluded. Asymptomatic small lesions are not considered active. Treated lesions may be considered inactive if they are stable for at least 3 months.'}, 'identificationModule': {'nctId': 'NCT01607905', 'briefTitle': 'Safety Study of KPT-330 (Selinexor) in Patients With Advanced or Metastatic Solid Tumor Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Karyopharm Therapeutics Inc'}, 'officialTitle': 'A Phase I Study of the Safety, Pharmacokinetics and Pharmacodynamics of Escalating Doses of the Selective Inhibitor of Nuclear Export/SINE Compound KPT-330 in Patients With Advanced or Metastatic Solid Tumor Malignancies', 'orgStudyIdInfo': {'id': 'KCP-330-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A (Colorectal Cancer)', 'description': 'Participants with colorectal cancer and liver metastasis received oral selinexor as single agent in 8 schedules, Schedule1: ≤12milligrams per meter square(mg/m\\^2) 3 times weekly(TIW) during Weeks 1 and 3, twice weekly(BIW) during Weeks 2 and 4 up to 10 doses/cycle(28 days/cycle); Schedule2: \\>12mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle(28 days/cycle); Schedule3: ≥30mg/m\\^2 BIW(Days 1 and 3) up to 8 doses/cycle(28 days/cycle); Schedule4: ≥20mg/m\\^2 BIW(Days 1 and 2) up to 8 doses/cycle(28 days/cycle); Schedule5: ≥35mg/m\\^2 BIW(Days 1 and 4) up to 8 doses(28 days/cycle); Schedule6: ≥20mg/m\\^2 BIW(Days 1 and 4) after 500 mg(Week 1) to 1000 mg(Week 2 onwards) acetaminophen(given 1 hour prior to each selinexor dose) up to 8 doses/cycle (28 days/cycle); Schedule7: ≥50mg/m\\^2 once weekly(QW) up to 4 doses/cycle(28 days per cycle); Schedule8: ≥45mg/m\\^2 BIW(Days 1 and 3) up to 4 doses/cycle(21 days/cycle), until disease progression, death, or unacceptable toxicity.', 'interventionNames': ['Drug: Selinexor', 'Drug: Acetaminophen']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B (Gynecological Cancer)', 'description': 'Participants with gynecological cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.', 'interventionNames': ['Drug: Selinexor']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C (Squamous Cell Cancer)', 'description': 'Participants with squamous cell cancer received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.', 'interventionNames': ['Drug: Selinexor']}, {'type': 'EXPERIMENTAL', 'label': 'Arm D (Castrate-resistant Prostate Cancer)', 'description': 'Participants with castrate-resistant prostate cancer (CRPC) received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.', 'interventionNames': ['Drug: Selinexor']}, {'type': 'EXPERIMENTAL', 'label': 'Arm E (Glioblastoma Multiforme)', 'description': 'Participants with glioblastoma multiforme (GBM) received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.', 'interventionNames': ['Drug: Selinexor']}, {'type': 'EXPERIMENTAL', 'label': 'Arm F (Melanoma)', 'description': 'Participants with Melanoma received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.', 'interventionNames': ['Drug: Selinexor']}, {'type': 'EXPERIMENTAL', 'label': 'Arm G (Other Solid Tumors)', 'description': 'Participants with other solid tumors received oral selinexor as a single agent in eight schedules, Schedule 1: ≤12 mg/m\\^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: \\>12 mg/m\\^2 TIW during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m\\^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m\\^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m\\^2 BIW (Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m\\^2 QW up to 4 doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m\\^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.', 'interventionNames': ['Drug: Selinexor']}], 'interventions': [{'name': 'Selinexor', 'type': 'DRUG', 'otherNames': ['KPT-330', 'XPOVIO'], 'description': 'Participants in this study will receive selinexor orally at dose levels specified for their respective dose cohorts. Dosing will begin at 3 mg/m\\^2 twice a week and will escalate until the MTD or RP2D is determined. Cycles will be repeated in 4-week (28 days for schedule 1 to 7) and 3-week (21 days for schedule 8) intervals until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment will be permitted.', 'armGroupLabels': ['Arm A (Colorectal Cancer)', 'Arm B (Gynecological Cancer)', 'Arm C (Squamous Cell Cancer)', 'Arm D (Castrate-resistant Prostate Cancer)', 'Arm E (Glioblastoma Multiforme)', 'Arm F (Melanoma)', 'Arm G (Other Solid Tumors)']}, {'name': 'Acetaminophen', 'type': 'DRUG', 'description': 'Oral 500 mg (in Cycle 1, Week 1) to 1000 mg (in Cycle 1, Week 2 and onwards) of acetaminophen will be administered 1 hour prior to each selinexor dose up to 8 doses per cycle (28 days per cycle)', 'armGroupLabels': ['Arm A (Colorectal Cancer)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Gabrail Cancer Center', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': 'M5T 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karyopharm Therapeutics Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}