Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2026-01-05 @ 5:26 PM
Study NCT ID:
NCT01790503
Status:
COMPLETED
Last Update Posted:
2020-06-30
First Post:
2013-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 1b/2 Study of PLX3397 + Radiation Therapy + Temozolomide in Patients With Newly Diagnosed Glioblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'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': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000600259', 'term': 'pexidartinib'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CTRinfo@dsi.com', 'phone': '908-992-6400', 'title': 'Medical Director', 'organization': 'Daiichi Sankyo Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from baseline up to 30 days after the last dose, up to 4 years 4 months.', 'description': 'Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose.\n\nFor the Other (Not Including Serious) Adverse Events data reported, data available are AEs who meet the Common Toxicity Criteria for Adverse Events (CTCAE) \\>=3 criteria (which is for severity, rather than frequency).', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1b Dose Escalation - 600 mg/600 mg', 'description': 'Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Phase 1b Dose Escalation - 600 mg/800 mg', 'description': 'Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Phase 1b Dose Escalation - 600 mg/1000 mg', 'description': 'Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 1000 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Phase 1b Dose Escalation - 600 mg', 'description': 'Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks). No adjuvant therapy thereafter.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Phase 1b Dose Escalation - 800 mg/1000 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Phase 1b Dose Escalation - 800 mg (5 Days)', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Phase 1b Dose Escalation - 800 mg/600 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Phase 1b Dose Escalation - 800 mg/800 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Phase 1b Dose Escation - 800 mg (7 Days)', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) No adjuvant therapy thereafter.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG009', 'title': 'Phase 2 - 800 mg/800 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy, and temozolomide (5 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 18, 'seriousNumAtRisk': 27, 'deathsNumAffected': 1, 'seriousNumAffected': 13}, {'id': 'EG010', 'title': 'Phase 2 - 800 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 13, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Apraxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Herpes simplex encephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 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{'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Myopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Respirovirus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Summary of the Median Progression-free Survival (mPFS) in the Combined 800 mg, 5 Days/Week Dose Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined 800 mg, 5 Days/Week', 'description': 'All participants in Phase 1b or 2 who received 800 mg/day PLX3397 (5 days/week) during combination therapy.'}], 'classes': [{'title': 'mITT RP2D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '11.5'}]}]}, {'title': 'PP RP2D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '10.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years 4 months.', 'description': 'Progression was determined by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS) was analyzed based on the non-parametric Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mPFS was assessed in the modified intent-to-treat RP2D and the per protocol (PP) populations.'}, {'type': 'PRIMARY', 'title': 'Summary of the Median Progression-free Survival (mPFS) in the Study Group Compared With Historical Control From Medical Literature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RP2D', 'description': 'mPFS was assessed in the RP2D population at Cycle 1, Day 1.'}, {'id': 'OG001', 'title': 'RP2D-0525 (Cycle 1, Day 1)', 'description': 'mPFS was assessed in the RP2D population in the RTOG 0525 study at Cycle 1, Day 1.'}, {'id': 'OG002', 'title': 'RP2D-0825', 'description': 'mPFS was assessed in the RP2D population in the RTOG 0825 study at Cycle 2, Day 1.'}, {'id': 'OG003', 'title': 'RP2D-0525 (Rest Period, Day 15)', 'description': 'mPFS was assessed in the RP2D population in the RTOG 0525 study at the Rest Period, Day 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '10.4'}, {'value': '7.6', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '10.6'}, {'value': '7.0', 'groupId': 'OG002', 'lowerLimit': '5.1', 'upperLimit': '9.5'}, {'value': '6.1', 'groupId': 'OG003', 'lowerLimit': '4.4', 'upperLimit': '8.5'}]}]}], 'analyses': [{'pValue': '0.456', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.36', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.619', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.43', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.272', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.26', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years 4 months.', 'description': 'mPFS was based on model parameters estimated by maximum likelihood with a Newton-Raphson algorithm. The Radiation Therapy Oncology Group (RTOG) 0525 study was the main historical control used for statistical analysis. Additionally, RTOG-0825 was also used to support this outcome measure.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mPFS was based on model parameters estimated by maximum likelihood with a Newton-Raphson algorithm. The Radiation Therapy Oncology Group (RTOG) 0525 study was the main historical control.'}, {'type': 'SECONDARY', 'title': 'Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined 800 mg, 5 Days/Week', 'description': 'All participants in Phase 1b or 2 who received 800 mg/day PLX3397 (5 days/week) during combination therapy.'}], 'classes': [{'title': 'Age: 18-64 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '12.4'}]}]}, {'title': 'Age: 65+ years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '11.5'}]}]}, {'title': 'Extent of surgery: complete resection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '12.3'}]}]}, {'title': 'Extent of surgery: partial resection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '15.4'}]}]}, {'title': 'Baseline KPS: 70-89', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '4.5'}]}]}, {'title': 'Baseline KPS: 90-100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '14.7'}]}]}, {'title': 'MGMT status: methylated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '15.4'}]}]}, {'title': 'MGMT status: unmethylated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '10.2'}]}]}], 'analyses': [{'pValue': '0.440', 'groupIds': ['OG000'], 'groupDescription': 'Comparison between age subgroups: 18-64 years vs 65+ years', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.699', 'groupIds': ['OG000'], 'groupDescription': 'Comparison between extent of surgery subgroups: complete resection vs partial resection', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.003', 'groupIds': ['OG000'], 'groupDescription': 'Comparison between baseline KPS subgroups: 70-89 vs 90-100', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.201', 'groupIds': ['OG000'], 'groupDescription': 'Comparison between MGMT status subgroups: methylated vs unmethylated', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years 4 months.', 'description': 'Progression was determined by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS) was analyzed based on the non-parametric Kaplan-Meier method. mPFS was analyzed by age group, extent of surgery, baseline Karnofsky Performance Status (KPS), and O6-methylguanine-DNA methyltransferase status (MGMT).\n\nThe scale range for the baseline Karnofsky Performance Status is from 0-100, with 0 indicating that the participant is dead and 100 indicating that the participant is Normal no complaints, no evidence of disease. The higher the number, the better the outcome.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mPFS was assessed in the mITT RP2D population.'}, {'type': 'SECONDARY', 'title': 'Summary of the Overall Survival in The Study Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined 800 mg, 5 Days/Week', 'description': 'All participants in Phase 1b or 2 who received 800 mg/day PLX3397 (5 days/week) during combination therapy.'}], 'classes': [{'title': 'mITT RP2D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000', 'lowerLimit': '11.5', 'upperLimit': '24.5'}]}]}, {'title': 'PP RP2D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.4', 'comment': "In Kaplan-Meier analysis, the upper limit of median survival's confidence interval is non-estimable (NE) when the upper confidence interval curve does not drop to or below the 50% line", 'groupId': 'OG000', 'lowerLimit': '9.9', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed from date of first dose administered to date of death from any cause, assessed up to 4 years 4 months', 'description': 'Overall Survival (OS) was defined as the number of days from the first day of treatment (C1D1) to the date of death and analyzed using a non-parametric Kaplan Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'OS was assessed in the mITT RP2D and PP RP2D populations.'}, {'type': 'SECONDARY', 'title': 'Summary of the Overall Survival in the Study Group Compared With Historical Control From Medical Literature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RP2D', 'description': 'OS was assessed in the RP2D population at Cycle 1, Day 1.'}, {'id': 'OG001', 'title': 'RP2D-0525 (Cycle 1, Day 1)', 'description': 'OS was assessed in the RP2D population in the RTOG 0525 study at Cycle 1, Day 1.'}, {'id': 'OG002', 'title': 'RP2D-0825', 'description': 'OS was assessed in the RP2D population in the RTOG 0825 study at Cycle 2, Day 1.'}, {'id': 'OG003', 'title': 'RP2D-0525 (Rest Period, Day 15)', 'description': 'OS was assessed in the RP2D population in the RTOG 0525 study at the Rest Period, Day 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '12.6', 'upperLimit': '28.0'}, {'value': '20.2', 'groupId': 'OG001', 'lowerLimit': '12.9', 'upperLimit': '31.6'}, {'value': '17.0', 'groupId': 'OG002', 'lowerLimit': '11.3', 'upperLimit': '25.6'}, {'value': '16.9', 'groupId': 'OG003', 'lowerLimit': '10.8', 'upperLimit': '26.5'}]}]}], 'analyses': [{'pValue': '0.389', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.47', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.393', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.63', 'ciUpperLimit': '1.42', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.469', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.63', 'ciUpperLimit': '1.54', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed from date of first dose administered to the date of death from any cause, assessed up to 4 years 4 months.', 'description': 'Overall Survival was calculated using a parametric model. The Radiation Therapy Oncology Group (RTOG) 0525 study was the main historical control used for statistical analysis. Additionally, RTOG-0825 was also used to support this outcome measure', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Median OS was based on model parameters estimated by maximum likelihood with a Newton-Raphson algorithm. The Radiation Therapy Oncology Group (RTOG) 0525 study was the main historical control.'}, {'type': 'SECONDARY', 'title': 'Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined 800 mg, 5 Days/Week', 'description': 'All participants in Phase 1b or 2 who received 800 mg/day PLX3397 (5 days/week) during combination therapy.'}], 'classes': [{'title': 'Age group: 18-64 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.3', 'comment': "In Kaplan-Meier analysis, the upper limit of median survival's confidence interval is non-estimable (NE) when the upper confidence interval curve does not drop to or below the 50% line", 'groupId': 'OG000', 'lowerLimit': '12.3', 'upperLimit': 'NA'}]}]}, {'title': 'Age group: 65+ years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '24.5'}]}]}, {'title': 'Extent of surgery: complete resection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '9.9', 'upperLimit': '24.5'}]}]}, {'title': 'Extent of surgery: partial resection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '13'}]}]}, {'title': 'Basline KPS: 70-89', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '12.4'}]}]}, {'title': 'Baseline KPS: 90-100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '13.1', 'upperLimit': '24'}]}]}, {'title': 'MGMT status: methylated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '9.7', 'upperLimit': '15'}]}]}, {'title': 'MGMT: unmethylated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '20.7'}]}]}], 'analyses': [{'pValue': '0.063', 'groupIds': ['OG000'], 'groupDescription': 'Comparison between age subgroups: 18-64 years vs 65+ years', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.969', 'groupIds': ['OG000'], 'groupDescription': 'Comparison between extent of surgery subgroups: complete resection vs partial resection', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'Comparison between baseline KPS subgroups: 70-89 vs 90-100', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.501', 'groupIds': ['OG000'], 'groupDescription': 'Comparison between MGMT status subgroups: methylated vs unmethylated', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed from date of first dose administered to the date of death from any cause, assessed up to 4 years 4 months.', 'description': 'Overall Survival was calculated using a non-parametric Kaplan-Meier analysis method. Median OS was analyzed by age group, extent of surgery, baseline Karnofsky Performance Status (KPS), and O6-methylguanine-DNA methyltransferase status (MGMT).\n\nThe scale range for the baseline Karnofsky Performance Status is from 0-100, with 0 indicating that the participant is dead and 100 indicating that the participant is Normal no complaints, no evidence of disease. The higher the number, the better the outcome.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'OS was assessed in the mITT RP2D population.'}, {'type': 'SECONDARY', 'title': 'Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined 800 mg, 5 Days/Week', 'description': 'All participants in Phase 1b or 2 who received 800 mg/day PLX3397 (5 days/week) during combination therapy.'}], 'classes': [{'title': 'Age group: 18-64 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Complete response (CR)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Partial response (PR)', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'CR+PR', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Stable disease', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Progressive disease', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Unable to access', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Age group: 65+ years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Complete response (CR)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Partial response (PR)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'CR+PR', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stable disease', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Progressive disease', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Unable to access', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Complete resection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Complete response (CR)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Partial response (PR)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'CR+PR', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Stable disease', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Progressive disease', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Unable to access', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Partial resection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Complete response (CR)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Partial response (PR)', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'CR+PR', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Stable disease', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Progressive disease', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Unable to access', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Baseline KPS: 70-89', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Complete response (CR)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Partial response (PR)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'CR+PR', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stable disease', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Progressive disease', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Unable to access', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Baseline KPS: 90-100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Complete response (CR)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Partial response (PR)', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'CR+PR', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Stable disease', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Progressive disease', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Unable to access', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'MGMT status: methylated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Complete response (CR)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Partial response (PR)', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'CR+PR', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Stable disease', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Progressive disease', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Unable to access', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'MGMT status: unmethylated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Complete response (CR)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Partial response (PR)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'CR+PR', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Stable disease', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Progressive disease', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Unable to access', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.705', 'groupIds': ['OG000'], 'groupDescription': 'Comparison between age subgroups: 18-64 years vs 65+ years', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '>0.999', 'groupIds': ['OG000'], 'groupDescription': 'Comparison between extent of surgery subgroups: complete resection vs partial resection', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.099', 'groupIds': ['OG000'], 'groupDescription': 'Comparison between baseline KPS subgroups: 70-89 vs 90-100', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.348', 'groupIds': ['OG000'], 'groupDescription': 'Comparison between MGMT status subgroups: methylated vs unmethylated', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed from Baseline and every 8 weeks, up to 4 years 4 months', 'description': 'Best Overall Response (based on the RANO response) was defined as the highest overall response recorded from the start of study treatment until the end of treatment. Per the Response Assessment in Neuro-Oncology (RANO) criteria for measurable lesions and assessed by Cranial MRI scan, summarized as: Complete Response (CR), Disappearance of all enhancing disease (measurable and non-measurable); Partial Response (PR), \\>=50% decrease of all measurable enhancing lesions; Stable disease, does not qualify for complete response, partial response, or progression, and progression, \\>25% increase in enhancing lesions despite stable or increasing steroid use or any new lesions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Best Overall Response was assessed in the mITT RP2D population.'}, {'type': 'SECONDARY', 'title': 'Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b Dose Escalation - 600 mg/600 mg', 'description': 'Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'OG001', 'title': 'Phase 1b Dose Escalation - 600 mg/800 mg', 'description': 'Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'OG002', 'title': 'Phase 1b Dose Escalation - 600 mg/1000 mg', 'description': 'Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 1000 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'OG003', 'title': 'Phase 1b Dose Escalation - 600 mg', 'description': 'Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks). No adjuvant therapy thereafter.'}, {'id': 'OG004', 'title': 'Phase 1b Dose Escalation - 800 mg/1000 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'OG005', 'title': 'Phase 1b Dose Escalation - 800 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.'}, {'id': 'OG006', 'title': 'Phase 1b Dose Escalation - 800 mg/600 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'OG007', 'title': 'Phase 1b Dose Escalation - 800 mg/800 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'OG008', 'title': 'Phase 1b Dose Escation - 800 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.'}], 'classes': [{'title': 'General Disorders and Administrative Site', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}]}, {'title': 'Nervous System Disorders', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}]}, {'title': 'Skin and Subcutaneous Tissue Disorders', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Gastrointestinal Disorders', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}]}, {'title': 'Metabolism and Nutrition Disorders', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}]}, {'title': 'Psychiatric Disorders', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Infections and Infestations', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}]}, {'title': 'Investigations', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}]}, {'title': 'Respiratory, Thoracic, and Mediastinal Disorders', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}]}, {'title': 'Musculoskeletal and Connective Tissue Disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Blood and Lymphatic Tissue Disorders', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Vascular Disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}]}, {'title': 'Renal and Urinary Disorders', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Eye Disorders', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Injury, Poisoning, and Procedural Complications', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Ear and Labyrinth', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Endocrine Disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Cardiac Disorders', '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'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Hepatobiliary Disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Reproductive System and Breast Disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Immune System Disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Neoplasms Benign, Malignant, and Unspecified', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 30 days after last dose, up to 4 years 4 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety was assessed in the mITT population.'}, {'type': 'SECONDARY', 'title': 'Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 - 800 mg/800 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy, and temozolomide (5 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'OG001', 'title': 'Phase 2 - 800 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.'}, {'id': 'OG002', 'title': 'Phase 2 Total', 'description': 'All participants in Phase 2 who received 800 mg/day PLX3397 in combination therapy.'}, {'id': 'OG003', 'title': 'Combined 800 mg, 5 Days/Week', 'description': 'All participants in Phase 1b or 2 who received 800 mg/day PLX3397 (5 days/week) during combination therapy.'}], 'classes': [{'title': 'General Disorders and Administration Site', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}]}, {'title': 'Skin and Subcutaneous Tissue Disorders', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}]}, {'title': 'Nervous System Disorders', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}]}, {'title': 'Gastrointestinal Disorders', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}]}, {'title': 'Metabolism and Nutrition Disorders', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}]}, {'title': 'Psychiatric Disorders', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}]}, {'title': 'Investigations', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}]}, {'title': 'Musculoskeletal and Connective Tissue Disorders', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}]}, {'title': 'Blood and Lymphatic System Disorders', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'Injury, Poisoning, and Procedural Complications', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'Eye Disorders', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Vascular Disorders', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'Respiratory, Thoracic, and Mediastinal Disorders', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Renal and Urinary Disorders', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Cardiac Disorders', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Endocrine Disorders', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Ear and Labyrinth Disorders', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Reproductive System and Breast Disorders', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Neoplasms Benign, Malignant, and Unspecified', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Hepatobiliary Disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Immune System Disorders', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 30 days after last dose, up to 4 years 4 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety was assessed in the mITT population.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b Dose Escalation - 600 mg/600 mg', 'description': 'Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'OG001', 'title': 'Phase 1b Dose Escalation - 600 mg/800 mg', 'description': 'Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'OG002', 'title': 'Phase 1b Dose Escalation - 600 mg/1000 mg', 'description': 'Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 1000 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'OG003', 'title': 'Phase 1b Dose Escalation - 600 mg', 'description': 'Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks). No adjuvant therapy thereafter.'}, {'id': 'OG004', 'title': 'Phase 1b Dose Escalation - 800 mg/1000 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'OG005', 'title': 'Phase 1b Dose Escalation - 800 mg (5 Days)', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.'}, {'id': 'OG006', 'title': 'Phase 1b Dose Escalation - 800 mg/600 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'OG007', 'title': 'Phase 1b Dose Escalation - 800 mg/800 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'OG008', 'title': 'Phase 1b Dose Escation - 800 mg (No Adjuvant Therapy)', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) No adjuvant therapy thereafter.'}], 'classes': [{'title': 'Thrombocytopenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Neutropenia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Anaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Lymphopenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'AST increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Platelet count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Neutrophil count decreased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}]}, {'title': 'Leukopenia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Febrile neutropenia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'ALT increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Bone marrow failure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Haemolysis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'White blood cell decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Lymphocyte count decreased', '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'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 30 days after last dose, up to 4 years 4 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Abnormal chemistry and hematology values were assessed in the mITT population.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 - 800 mg/800 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy, and temozolomide (5 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'OG001', 'title': 'Phase 2 - 800 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.'}, {'id': 'OG002', 'title': 'Phase 2 Total', 'description': 'All participants in Phase 2 who received 800 mg/day PLX3397 in combination therapy.'}, {'id': 'OG003', 'title': 'Combined 800 mg, 5 Days/Week', 'description': 'All participants in Phase 1b or 2 who received 800 mg/day PLX3397 (5 days/week) during combination therapy.'}], 'classes': [{'title': 'Neutropenia', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Thrombocytopenia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Anaemia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'ALT increased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'AST increased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Platelet count decreased', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Lymphopenia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'White blood cell count decreased', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophil count decreased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Leukopenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Febrile neutropenia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocyte count decreased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Blood alkaline phosphatase increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Blood creatinine increased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'DRESS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Liver function test abnormal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Bone marrow failure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Haemolysis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Blood bilirubin increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Blood iron decreased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 30 days after last dose, up to 4 years 4 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Abnormal chemistry and hematology values were assessed in the mITT population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1b Dose Escalation - 600 mg/600 mg', 'description': 'Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'FG001', 'title': 'Phase 1b Dose Escalation - 600 mg/800 mg', 'description': 'Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter'}, {'id': 'FG002', 'title': 'Phase 1b Dose Escalation - 600 mg/1000 mg', 'description': 'Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 1000 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'FG003', 'title': 'Phase 1b Dose Escalation - 600 mg', 'description': 'Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks). No adjuvant therapy thereafter.'}, {'id': 'FG004', 'title': 'Phase 1b Dose Escalation - 800 mg/1000 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'FG005', 'title': 'Phase 1b Dose Escalation - 800 mg (5 Days)', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.'}, {'id': 'FG006', 'title': 'Phase 1b Dose Escalation - 800 mg/600 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'FG007', 'title': 'Phase 1b Dose Escalation - 800 mg/800 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'FG008', 'title': 'Phase 1b Dose Escalation - 800 mg (7 Days)', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) No adjuvant therapy thereafter.'}, {'id': 'FG009', 'title': 'Phase 2 - 800 mg/800 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy, and temozolomide (5 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'FG010', 'title': 'Phase 2 - 800 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '27'}, {'groupId': 'FG010', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '26'}, {'groupId': 'FG010', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '4'}, {'groupId': 'FG010', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '17'}, {'groupId': 'FG010', 'numSubjects': '7'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Non Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 65 participants (22 in Phase 1b; 43 in Phase 2) who met all inclusion criteria and no exclusion criteria were enrolled and treated in the study at 10 clinic sites in the United States.', 'preAssignmentDetails': 'This study included Phase 1b dose escalation where 5 cohorts were planned to be enrolled, each with approximately 7 participants (3+3 design) and Phase 2 where 37 participants were planned to be enrolled with the 7 participants treated at the RP2D level determined in the Phase 1b dose escalation phase yielding approximately 44 participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '27', 'groupId': 'BG009'}, {'value': '16', 'groupId': 'BG010'}, {'value': '65', 'groupId': 'BG011'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1b Dose Escalation - 600 mg/600 mg', 'description': 'Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'BG001', 'title': 'Phase 1b Dose Escalation - 600 mg/800 mg', 'description': 'Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'BG002', 'title': 'Phase 1b Dose Escalation - 600 mg/1000 mg', 'description': 'Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 1000 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'BG003', 'title': 'Phase 1b Dose Escalation - 600 mg', 'description': 'Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks). No adjuvant therapy thereafter'}, {'id': 'BG004', 'title': 'Phase 1b Dose Escalation - 800 mg/1000 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'BG005', 'title': 'Phase 1b Dose Escalation - 800 mg (5 Days)', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.'}, {'id': 'BG006', 'title': 'Phase 1b Dose Escalation - 800 mg/600 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'BG007', 'title': 'Phase 1b Dose Escalation - 800 mg/800 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'BG008', 'title': 'Phase 1b Dose Escation - 800 mg (7 Days)', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) No adjuvant therapy thereafter.'}, {'id': 'BG009', 'title': 'Phase 2 - 800 mg/800 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy, and temozolomide (5 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.'}, {'id': 'BG010', 'title': 'Phase 2 - 800 mg', 'description': 'Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.'}, {'id': 'BG011', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '11', 'groupId': 'BG010'}, {'value': '37', 'groupId': 'BG011'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '20', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}, {'value': '28', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.3', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '23.0', 'spread': '0', 'groupId': 'BG001'}, {'value': '73', 'spread': '0', 'groupId': 'BG002'}, {'value': '48.0', 'spread': '17.0', 'groupId': 'BG003'}, {'value': '50.8', 'spread': '15.7', 'groupId': 'BG004'}, {'value': '60.8', 'spread': '8.6', 'groupId': 'BG005'}, {'value': '30.0', 'spread': '0', 'groupId': 'BG006'}, {'value': '51.0', 'spread': '0', 'groupId': 'BG007'}, {'value': '53.3', 'spread': '4.2', 'groupId': 'BG008'}, {'value': '55.7', 'spread': '10.8', 'groupId': 'BG009'}, {'value': '59.0', 'spread': '10.7', 'groupId': 'BG010'}, {'value': '55.3', 'spread': '11.9', 'groupId': 'BG011'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}, {'value': '24', 'groupId': 'BG011'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '19', 'groupId': 'BG009'}, {'value': '9', 'groupId': 'BG010'}, {'value': '41', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}]}, {'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'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '25', 'groupId': 'BG009'}, {'value': '16', 'groupId': 'BG010'}, {'value': '58', 'groupId': 'BG011'}]}, {'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'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '27', 'groupId': 'BG009'}, {'value': '16', 'groupId': 'BG010'}, {'value': '65', 'groupId': 'BG011'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-14', 'size': 15299409, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-22T16:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'dispFirstSubmitDate': '2018-11-13', 'completionDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-19', 'studyFirstSubmitDate': '2013-02-07', 'dispFirstSubmitQcDate': '2018-11-13', 'resultsFirstSubmitDate': '2019-08-22', 'studyFirstSubmitQcDate': '2013-02-11', 'dispFirstPostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-18', 'studyFirstPostDateStruct': {'date': '2013-02-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Summary of the Median Progression-free Survival (mPFS) in the Combined 800 mg, 5 Days/Week Dose Group', 'timeFrame': 'Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years 4 months.', 'description': 'Progression was determined by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS) was analyzed based on the non-parametric Kaplan-Meier method.'}, {'measure': 'Summary of the Median Progression-free Survival (mPFS) in the Study Group Compared With Historical Control From Medical Literature', 'timeFrame': 'Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years 4 months.', 'description': 'mPFS was based on model parameters estimated by maximum likelihood with a Newton-Raphson algorithm. The Radiation Therapy Oncology Group (RTOG) 0525 study was the main historical control used for statistical analysis. Additionally, RTOG-0825 was also used to support this outcome measure.'}], 'secondaryOutcomes': [{'measure': 'Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose', 'timeFrame': 'Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years 4 months.', 'description': 'Progression was determined by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS) was analyzed based on the non-parametric Kaplan-Meier method. mPFS was analyzed by age group, extent of surgery, baseline Karnofsky Performance Status (KPS), and O6-methylguanine-DNA methyltransferase status (MGMT).\n\nThe scale range for the baseline Karnofsky Performance Status is from 0-100, with 0 indicating that the participant is dead and 100 indicating that the participant is Normal no complaints, no evidence of disease. The higher the number, the better the outcome.'}, {'measure': 'Summary of the Overall Survival in The Study Population', 'timeFrame': 'Assessed from date of first dose administered to date of death from any cause, assessed up to 4 years 4 months', 'description': 'Overall Survival (OS) was defined as the number of days from the first day of treatment (C1D1) to the date of death and analyzed using a non-parametric Kaplan Meier method.'}, {'measure': 'Summary of the Overall Survival in the Study Group Compared With Historical Control From Medical Literature', 'timeFrame': 'Assessed from date of first dose administered to the date of death from any cause, assessed up to 4 years 4 months.', 'description': 'Overall Survival was calculated using a parametric model. The Radiation Therapy Oncology Group (RTOG) 0525 study was the main historical control used for statistical analysis. Additionally, RTOG-0825 was also used to support this outcome measure'}, {'measure': 'Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose', 'timeFrame': 'Assessed from date of first dose administered to the date of death from any cause, assessed up to 4 years 4 months.', 'description': 'Overall Survival was calculated using a non-parametric Kaplan-Meier analysis method. Median OS was analyzed by age group, extent of surgery, baseline Karnofsky Performance Status (KPS), and O6-methylguanine-DNA methyltransferase status (MGMT).\n\nThe scale range for the baseline Karnofsky Performance Status is from 0-100, with 0 indicating that the participant is dead and 100 indicating that the participant is Normal no complaints, no evidence of disease. The higher the number, the better the outcome.'}, {'measure': 'Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose', 'timeFrame': 'Assessed from Baseline and every 8 weeks, up to 4 years 4 months', 'description': 'Best Overall Response (based on the RANO response) was defined as the highest overall response recorded from the start of study treatment until the end of treatment. Per the Response Assessment in Neuro-Oncology (RANO) criteria for measurable lesions and assessed by Cranial MRI scan, summarized as: Complete Response (CR), Disappearance of all enhancing disease (measurable and non-measurable); Partial Response (PR), \\>=50% decrease of all measurable enhancing lesions; Stable disease, does not qualify for complete response, partial response, or progression, and progression, \\>25% increase in enhancing lesions despite stable or increasing steroid use or any new lesions.'}, {'measure': 'Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population', 'timeFrame': 'Baseline up to 30 days after last dose, up to 4 years 4 months'}, {'measure': 'Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population', 'timeFrame': 'Baseline up to 30 days after last dose, up to 4 years 4 months'}, {'measure': 'Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population', 'timeFrame': 'Baseline up to 30 days after last dose, up to 4 years 4 months'}, {'measure': 'Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population', 'timeFrame': 'Baseline up to 30 days after last dose, up to 4 years 4 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['glioblastoma', 'GBM'], 'conditions': ['Patients With Newly Diagnosed Glioblastoma']}, 'referencesModule': {'references': [{'pmid': '24101040', 'type': 'RESULT', 'citation': 'Gilbert MR, Wang M, Aldape KD, Stupp R, Hegi ME, Jaeckle KA, Armstrong TS, Wefel JS, Won M, Blumenthal DT, Mahajan A, Schultz CJ, Erridge S, Baumert B, Hopkins KI, Tzuk-Shina T, Brown PD, Chakravarti A, Curran WJ Jr, Mehta MP. Dose-dense temozolomide for newly diagnosed glioblastoma: a randomized phase III clinical trial. J Clin Oncol. 2013 Nov 10;31(32):4085-91. doi: 10.1200/JCO.2013.49.6968. Epub 2013 Oct 7.'}, {'pmid': '24552317', 'type': 'RESULT', 'citation': 'Gilbert MR, Dignam JJ, Armstrong TS, Wefel JS, Blumenthal DT, Vogelbaum MA, Colman H, Chakravarti A, Pugh S, Won M, Jeraj R, Brown PD, Jaeckle KA, Schiff D, Stieber VW, Brachman DG, Werner-Wasik M, Tremont-Lukats IW, Sulman EP, Aldape KD, Curran WJ Jr, Mehta MP. A randomized trial of bevacizumab for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb 20;370(8):699-708. doi: 10.1056/NEJMoa1308573.'}]}, 'descriptionModule': {'briefSummary': 'The study objectives are to assess the potential for PLX3397 to improve the efficacy of standard of care radiation therapy (RT) + temozolomide in patients with newly diagnosed glioblastoma (GBM).', 'detailedDescription': 'Study drug will be administered twice daily for 7 days prior to the initiation of RT (radiation therapy)and will continue twice daily during the course of RT. The RT schedule will be once daily for 5 days per week for 6 weeks (total radiation dose of 60 Gy. Oral temozolomide will be administered once daily (7 days per week) for the duration of RT. Four weeks after the completion of the course of RT, patients will be started on once-daily adjuvant temozolomide (Day 1-5 of a 28 day cycle) and PLX3397 twice daily (28 days of a 28 day cycle) for up to 12 cycles in the absence of progressive disease or unacceptable toxicities. After discontinuation of study drug, patients will continue to be followed for OS every 6 months. For patients participating in the run-in Phase 1b of the study, intra patient dose escalation will be permitted after a RP2D has been established. The Phase 2 portion of the study will enroll patients to be treated with PLX3397 at RP2D.\n\nFor the Phase 1b portion of the study, 2 cohorts (800 mg/day and 1000 mg/day) are planned to be enrolled at approximately 7-10 sites. Each cohort will consist of approximately 7 patients. Therefore, a minimum of 14 patients are planned to be enrolled in Phase 1b. Additional patients may be required for replacement patients, or if lower dose cohorts (600 mg or 400 mg) are required. For the Phase 2 portion of the study, enrollment is planned to include approximately 44 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female patients ≥18 years old.\n* Histologically confirmed definitive GBM or gliosarcoma by partial or complete surgical resection (i.e. not by biopsy only) within 5 weeks prior to PLX3397 administration (C1D1). Tumor must have a supratentorial component. For all patients, availability of a surgical paraffin tumor block sufficient to generate at least 20 unstained slides; or, if a paraffin tumor block is unavailable, at least 20 unstained slides.\n* The patient must have recovered from the effects of surgery, post-operative infection, and other complications before study registration.\n* A diagnostic contrast-enhanced MRI or CT scan of the brain must be performed preoperatively and postoperatively prior to the initiation of radiotherapy, within 28 days (preferably 14 days) prior to C1D1.\n* Patients unable to undergo MR imaging because of non-compatible devices can be enrolled, provided pre- and post-operative contrast-enhanced CT scans are obtained and are of sufficient quality.\n* Patients must receive RT at the participating institution.\n* Women of child-bearing potential must have a negative pregnancy test within 14 days of initiation of dosing and must agree to use an acceptable method of birth control while on study drug and for 3 months after the last dose. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year. Men of child-bearing potential must also agree to use an acceptable method of birth control while on study drug, and for 3 months after the last dose.\n* Karnofsky performance status of ≥70.\n* Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥1.5x 109/L, Hgb \\>10 g/dL, platelet count ≥100 x 109/L, AST/ALT ≤2.5x ULN, creatinine ≤1.5x ULN).\n* Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements.\n\nExclusion Criteria:\n\n* Evidence of recurrent GBM or metastases detected outside of the cranial vault.\n* Investigational drug use within 28 days of the first dose of PLX3397 or concurrently.\n* Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment.\n* Prior radiation or chemotherapy for glioblastoma or glioma.\n* Prior chemotherapy or radiosensitizers for cancer of the head and neck (except for T1 glottic cancer) that would result in an overlap of radiation fields.\n* Prior allergic reaction to temozolomide.\n* History of Grade 2 (CTCAE v4) or greater acute intracranial hemorrhage.\n* Active cancer (either concurrent or within the last 3 years) that requires non-surgical therapy (e.g. chemotherapy or radiation therapy), with the exception of surgically treated basal or squamous cell carcinoma of the skin, melanoma in-situ, or carcinoma in-situ of the cervix.\n* Chronic active hepatitis B or C.\n* Refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption of study drug.\n* Patients with serious illnesses, uncontrolled infection, medical conditions, or other medical history including abnormal laboratory results, which in the investigator's opinion would be likely to interfere with a patient's participation in the study, or with the interpretation of the results.\n* Women of child-bearing potential who are pregnant or breast feeding.\n* At Screening QTcF ≥450 msec for males and ≥470 msec for females."}, 'identificationModule': {'nctId': 'NCT01790503', 'briefTitle': 'A Phase 1b/2 Study of PLX3397 + Radiation Therapy + Temozolomide in Patients With Newly Diagnosed Glioblastoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'An Open Label Phase 1b/2 Study of Orally Administered PLX3397 in Combination With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma', 'orgStudyIdInfo': {'id': 'PLX108-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1b dose escalation - 600mg/day PLX3397 cohort', 'description': '600mg/day PLX3397, Radiation Therapy, and Temozolomide', 'interventionNames': ['Drug: PLX3397', 'Radiation: Radiation Therapy', 'Drug: Temozolomide']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b dose escalation - 800mg/day PLX3397', 'description': '800mg/day PLX3397, Radiation Therapy, and Temozolomide', 'interventionNames': ['Drug: PLX3397', 'Radiation: Radiation Therapy', 'Drug: Temozolomide']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b dose escalation - 1000 mg/day PLX3397 cohort', 'description': '1000 mg/day PLX3397, Radiation Therapy, and Temozolomide', 'interventionNames': ['Drug: PLX3397', 'Radiation: Radiation Therapy', 'Drug: Temozolomide']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 - Recommended phase 2 dose of PLX3397', 'description': 'Recommended phase 2 dose of PLX3397 (800mg/day), Radiation therapy, and Temozolomide', 'interventionNames': ['Drug: PLX3397', 'Radiation: Radiation Therapy', 'Drug: Temozolomide']}], 'interventions': [{'name': 'PLX3397', 'type': 'DRUG', 'otherNames': ['Pexidartinib'], 'armGroupLabels': ['Phase 1b dose escalation - 1000 mg/day PLX3397 cohort', 'Phase 1b dose escalation - 600mg/day PLX3397 cohort', 'Phase 1b dose escalation - 800mg/day PLX3397', 'Phase 2 - Recommended phase 2 dose of PLX3397']}, {'name': 'Radiation Therapy', 'type': 'RADIATION', 'armGroupLabels': ['Phase 1b dose escalation - 1000 mg/day PLX3397 cohort', 'Phase 1b dose escalation - 600mg/day PLX3397 cohort', 'Phase 1b dose escalation - 800mg/day PLX3397', 'Phase 2 - Recommended phase 2 dose of PLX3397']}, {'name': 'Temozolomide', 'type': 'DRUG', 'otherNames': ['TMZ', 'Temodar'], 'armGroupLabels': ['Phase 1b dose escalation - 1000 mg/day PLX3397 cohort', 'Phase 1b dose escalation - 600mg/day PLX3397 cohort', 'Phase 1b dose escalation - 800mg/day PLX3397', 'Phase 2 - Recommended phase 2 dose of PLX3397']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43210', 'city': 'Columbia', 'state': 'Ohio', 'country': 'United States', 'facility': 'James Cancer Hospital/Ohio State University', 'geoPoint': {'lat': 39.11173, 'lon': -84.43466}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Huntsman Cancer Institute University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Global Clinical Leader', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Daiichi Sankyo'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/daiichi-sankyo/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/', 'accessCriteria': "Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Plexxikon', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}