Viewing Study NCT03345095

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Ignite Creation Date: 2025-12-24 @ 1:10 PM
Ignite Modification Date: 2026-01-03 @ 11:10 PM
Study NCT ID: NCT03345095
Status: COMPLETED
Last Update Posted: 2025-07-01
First Post: 2017-11-07
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}}}}, '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': 'C475865', 'term': 'marizomib'}, {'id': 'D000077204', 'term': 'Temozolomide'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'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'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'thierry.gorlia@eortc.org', 'phone': '+32 2 7741652', 'title': 'Dr. Thierry Gorlia', 'organization': 'EORTC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study.', 'description': 'Both serious and non-serious AEs were collected. We reported serious adverse events (SAEs) and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental Arm', 'description': 'Radiotherapy + Temozolomide + Marizomib followed by adjuvant Temozolomide + Marizomib\n\nMarizomib: Intravenous administration of Marizomib\n\nTemozolomide: Oral Administration of Temozolomide\n\nradiotherapy: 60 Gy in 30 fractions over 6 weeks', 'otherNumAtRisk': 305, 'deathsNumAtRisk': 309, 'otherNumAffected': 300, 'seriousNumAtRisk': 305, 'deathsNumAffected': 55, 'seriousNumAffected': 114}, {'id': 'EG001', 'title': 'Standard Arm', 'description': 'Radiotherapy + Temozolomide followed by adjuvant Temozolomide\n\nTemozolomide: Oral Administration of Temozolomide\n\nradiotherapy: 60 Gy in 30 fractions over 6 weeks', 'otherNumAtRisk': 297, 'deathsNumAtRisk': 307, 'otherNumAffected': 283, 'seriousNumAtRisk': 297, 'deathsNumAffected': 57, 'seriousNumAffected': 80}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 29}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Sinus Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Sinus Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Supraventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Ear Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Ear Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Ear Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyperacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Presbyacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Vestibular Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': "Cushing's Syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Cushingoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 5}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Altered Visual Depth Perception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Asthenopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Blindness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dyschromatopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Eye Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Eye Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Eye Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Eye Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Eye Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Eyelid Function Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Eyelid Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Eyelid Ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Glare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypermetropia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Lacrimation Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Ocular Hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Optic Atrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Papilloedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Periorbital Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Periorbital Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Visual Field Defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Visual Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Vitreous Floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Xerophthalmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Anal Incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Aphthous Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 126}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 97}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dental Caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dental Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 10}], 'organSystem': 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{'term': 'Neoplasm Progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Peritumoural Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Squamous Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Squamous Cell 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'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Squamous Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Balance Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Brain Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Brain Stem Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Cerebral Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Cerebral Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Cerebral Venous Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Clonus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Cognitive Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Coordination Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Depressed Level Of Consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Generalised Tonic-Clonic Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Intracranial Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Ischaemic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Leukoencephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Motor Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nervous System Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Neurological Decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Neurological Symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Neuromyelitis Optica Spectrum Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nystagmus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Partial Seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Post Herpetic Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pyramidal Tract Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Radicular Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Status Epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Subdural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Vasogenic Cerebral Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Confusional State', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Delusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hallucination, Visual', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Impulsive Behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Paranoia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Psychomotor Retardation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Psychotic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Rash Maculo-Papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Stevens-Johnson Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Jugular Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Arm', 'description': 'Radiotherapy + Temozolomide + Marizomib followed by adjuvant Temozolomide + Marizomib\n\nMarizomib: Intravenous administration of Marizomib\n\nTemozolomide: Oral Administration of Temozolomide\n\nradiotherapy: 60 Gy in 30 fractions over 6 weeks'}, {'id': 'OG001', 'title': 'Standard Arm', 'description': 'Radiotherapy + Temozolomide followed by adjuvant Temozolomide\n\nTemozolomide: Oral Administration of Temozolomide\n\nradiotherapy: 60 Gy in 30 fractions over 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '16.13', 'groupId': 'OG000', 'lowerLimit': '14.92', 'upperLimit': '17.77'}, {'value': '15.08', 'groupId': 'OG001', 'lowerLimit': '13.73', 'upperLimit': '16.99'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization up to the date of death, assessed up to 49 months', 'description': 'Overall Survival (OS): OS is defined as the number of days from date of randomization to the date of death due to any cause. If a patient has not died, the data will be censored at the last date documented to be alive.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population is Intention-to-treat population (ITT): All randomized patients will be analyzed in the arm they were allocated by randomization'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Arm', 'description': 'Radiotherapy + Temozolomide + Marizomib followed by adjuvant Temozolomide + Marizomib\n\nMarizomib: Intravenous administration of Marizomib\n\nTemozolomide: Oral Administration of Temozolomide\n\nradiotherapy: 60 Gy in 30 fractions over 6 weeks'}, {'id': 'OG001', 'title': 'Standard Arm', 'description': 'Radiotherapy + Temozolomide followed by adjuvant Temozolomide\n\nTemozolomide: Oral Administration of Temozolomide\n\nradiotherapy: 60 Gy in 30 fractions over 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '6.34', 'groupId': 'OG000', 'lowerLimit': '5.82', 'upperLimit': '7.85'}, {'value': '6.11', 'groupId': 'OG001', 'lowerLimit': '4.93', 'upperLimit': '7.29'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': "From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first, assessed up to 49 months", 'description': 'PFS is defined as the number of days from date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology criteria (by investigator) or to the date of death due to any cause, if disease progression does not occur. Patients for whom neither death nor progression have been documented were censored on the date of the last radiological assessment that the patient was progression-free. If a patient with no post-baseline radiological assessment then the data were censored at the date of randomization. Patients with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where the patient was documented to be progression free. Patients who received new anti-cancer therapy or cancer-related surgery prior to progression or death were not censored at the last assessment where the patient was documented as progression free prior to the new therapy.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is Intention-to-treat population (ITT): All randomized patients will be analyzed in the arm they were allocated by randomization.'}, {'type': 'SECONDARY', 'title': 'Health-related Quality of Life (HRQol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Arm', 'description': 'Radiotherapy + Temozolomide + Marizomib followed by adjuvant Temozolomide + Marizomib\n\nMarizomib: Intravenous administration of Marizomib\n\nTemozolomide: Oral Administration of Temozolomide\n\nradiotherapy: 60 Gy in 30 fractions over 6 weeks'}, {'id': 'OG001', 'title': 'Standard Arm', 'description': 'Radiotherapy + Temozolomide followed by adjuvant Temozolomide\n\nTemozolomide: Oral Administration of Temozolomide\n\nradiotherapy: 60 Gy in 30 fractions over 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.8', 'groupId': 'OG000', 'lowerLimit': '-15.0', 'upperLimit': '-8.7'}, {'value': '-5.4', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '-2.9'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.4', 'ciLowerLimit': '-8.6', 'ciUpperLimit': '-2.5', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From randomization until progression or death which ever occurs first, reported at week 16 by the mean difference from baseline assessment.', 'description': 'HRQoL was assessed with the EORTC Quality of Life Questionnaire (QLQ-C30) version 3. The primary HRQol score is Physical Functioning. It is reported at week 16 during the Temozolomide (TMZ) maintenance phase. Physical functioning score is ranging 0 to 100. A large scores indicate a good physical functioning. A negative difference indicates a worsening physical functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'At week 16 during the TMZ maintenance phase, HRQol was obtained from 212 patients in the Experimental arm and 207 patients in the Standard arm.'}, {'type': 'SECONDARY', 'title': 'Mini Mental State Examination (MMSE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Arm', 'description': 'Radiotherapy + Temozolomide + Marizomib followed by adjuvant Temozolomide + Marizomib\n\nMarizomib: Intravenous administration of Marizomib\n\nTemozolomide: Oral Administration of Temozolomide\n\nradiotherapy: 60 Gy in 30 fractions over 6 weeks'}, {'id': 'OG001', 'title': 'Standard Arm', 'description': 'Radiotherapy + Temozolomide followed by adjuvant Temozolomide\n\nTemozolomide: Oral Administration of Temozolomide\n\nradiotherapy: 60 Gy in 30 fractions over 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.95', 'groupId': 'OG000', 'lowerLimit': '-1.51', 'upperLimit': '-0.38'}, {'value': '-0.39', 'groupId': 'OG001', 'lowerLimit': '-0.82', 'upperLimit': '0.04'}]}]}], 'analyses': [{'pValue': '0.15', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-1.27', 'ciUpperLimit': '0.16', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From the date of randomization until end of treatment. It is reported at week 16 by the mean difference from baseline assessment.', 'description': "MMSE is a brief, standardized tool to grade patients' neurocognitive function. It is an 11-question measure that tests five areas of neurocognitive function: orientation, registration, attention and calculation, recall, and language. A large MMSE score indicates a good cognitive functioning. The maximum MMSE score is 30 which corresponds to the best neurocognitive function and minimum MMSE score is 0 the worst neurocognitive function.The patient's neurocognitive function are considered 'impaired' if MMSE is 26 or less and 'normal' if it is 27 or more. MMSE has been validated and extensively used in both clinical practice and research. It is reported at week 16 during the Temozolomide (TMZ) maintenance phase. A negative difference indicates a worsening cognitive functioning. Difference range reported in the data table is min -19 and max 10. The mean difference is reported with 95% confidence interval (CI). A CI which excludes 0 indicates a significant mean MMSE score change.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'At week 16 during the TMZ maintenance phase, HRQol was obtained from 180 patients in the Experimental arm and 166 patients in the Standard arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental Arm', 'description': 'Radiotherapy + Temozolomide + Marizomib followed by adjuvant Temozolomide + Marizomib\n\nMarizomib: Intravenous administration of Marizomib\n\nTemozolomide: Oral Administration of Temozolomide\n\nradiotherapy: 60 Gy in 30 fractions over 6 weeks'}, {'id': 'FG001', 'title': 'Standard Arm', 'description': 'Radiotherapy + Temozolomide followed by adjuvant Temozolomide\n\nTemozolomide: Oral Administration of Temozolomide\n\nradiotherapy: 60 Gy in 30 fractions over 6 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '374'}, {'groupId': 'FG001', 'numSubjects': '375'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '249'}, {'groupId': 'FG001', 'numSubjects': '367'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '156'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '118'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patient registration was accepted from authorized investigators. Patients were registered on the Electronic Data Capture system. To access it, the investigator needed a user name and a password which were provided by the EORTC Headquarters. In case of problems investigators could contact the EORTC Clinical Data Manager. A Subject Identifier was allocated to the patient. This number allowed the identification of the patient in the Electronic Data Capture.', 'preAssignmentDetails': 'Eligibility criteria were checked at time of randomization. Once eligibility had been verified, treatment was randomly allocated to the patient, together with a sequential patient identification number. This number allowed the identification of the patients in the Electronic Data Capture system that was used to complete the Case Report Forms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'BG000'}, {'value': '375', 'groupId': 'BG001'}, {'value': '749', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental Arm', 'description': 'Radiotherapy + Temozolomide + Marizomib followed by adjuvant Temozolomide + Marizomib\n\nMarizomib: Intravenous administration of Marizomib\n\nTemozolomide: Oral Administration of Temozolomide\n\nradiotherapy: 60 Gy in 30 fractions over 6 weeks'}, {'id': 'BG001', 'title': 'Standard Arm', 'description': 'Radiotherapy + Temozolomide followed by adjuvant Temozolomide\n\nTemozolomide: Oral Administration of Temozolomide\n\nradiotherapy: 60 Gy in 30 fractions over 6 weeks'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '287', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '563', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.5', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '79'}, {'value': '58.0', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '79'}, {'value': '58.0', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '79'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '261', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '255', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '488', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '279', 'groupId': 'BG000'}, {'value': '290', 'groupId': 'BG001'}, {'value': '569', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Norway', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Karnofsky Performance Status', 'classes': [{'categories': [{'title': '70/80', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}, {'title': '90/100', 'measurements': [{'value': '248', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Karnofsky Performance Status Index allows patients to be classified as to their functional impairment. This can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for most serious illnesses. 100 Normal no complaints; no evidence of disease. 90 Able to carry on normal activity; minor signs or symptoms of disease. 80 Normal activity with effort; some signs or symptoms of disease. 70 Cares for self; unable to carry on normal activity or to do active work.', 'unitOfMeasure': 'Participants'}, {'title': 'Extent of surgery', 'classes': [{'categories': [{'title': 'Gross total', 'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}]}, {'title': 'Partial/biopsy', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '365', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-20', 'size': 1588745, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-16T04:04', 'hasProtocol': True}, {'date': '2021-03-18', 'size': 927549, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-08-16T04:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 749}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2017-11-07', 'resultsFirstSubmitDate': '2023-12-08', 'studyFirstSubmitQcDate': '2017-11-14', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-08', 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From the date of randomization up to the date of death, assessed up to 49 months', 'description': 'Overall Survival (OS): OS is defined as the number of days from date of randomization to the date of death due to any cause. If a patient has not died, the data will be censored at the last date documented to be alive.'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': "From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first, assessed up to 49 months", 'description': 'PFS is defined as the number of days from date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology criteria (by investigator) or to the date of death due to any cause, if disease progression does not occur. Patients for whom neither death nor progression have been documented were censored on the date of the last radiological assessment that the patient was progression-free. If a patient with no post-baseline radiological assessment then the data were censored at the date of randomization. Patients with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where the patient was documented to be progression free. Patients who received new anti-cancer therapy or cancer-related surgery prior to progression or death were not censored at the last assessment where the patient was documented as progression free prior to the new therapy.'}, {'measure': 'Health-related Quality of Life (HRQol)', 'timeFrame': 'From randomization until progression or death which ever occurs first, reported at week 16 by the mean difference from baseline assessment.', 'description': 'HRQoL was assessed with the EORTC Quality of Life Questionnaire (QLQ-C30) version 3. The primary HRQol score is Physical Functioning. It is reported at week 16 during the Temozolomide (TMZ) maintenance phase. Physical functioning score is ranging 0 to 100. A large scores indicate a good physical functioning. A negative difference indicates a worsening physical functioning.'}, {'measure': 'Mini Mental State Examination (MMSE)', 'timeFrame': 'From the date of randomization until end of treatment. It is reported at week 16 by the mean difference from baseline assessment.', 'description': "MMSE is a brief, standardized tool to grade patients' neurocognitive function. It is an 11-question measure that tests five areas of neurocognitive function: orientation, registration, attention and calculation, recall, and language. A large MMSE score indicates a good cognitive functioning. The maximum MMSE score is 30 which corresponds to the best neurocognitive function and minimum MMSE score is 0 the worst neurocognitive function.The patient's neurocognitive function are considered 'impaired' if MMSE is 26 or less and 'normal' if it is 27 or more. MMSE has been validated and extensively used in both clinical practice and research. It is reported at week 16 during the Temozolomide (TMZ) maintenance phase. A negative difference indicates a worsening cognitive functioning. Difference range reported in the data table is min -19 and max 10. The mean difference is reported with 95% confidence interval (CI). A CI which excludes 0 indicates a significant mean MMSE score change."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Marizomib', 'Temozolomide', 'Glioblastoma', 'Phase III'], 'conditions': ['Newly Diagnosed Glioblastoma']}, 'descriptionModule': {'briefSummary': 'The standard of care for newly diagnosed glioblastoma includes surgery, involved-field radiotherapy, and concomitant and six cycles of maintenance temozolomide chemotherapy, however the prognosis remains dismal. Marizomib has been tested in patients with newly diagnosed and recurrent glioblastoma in phase I and phase II studies. In patients with recurrent glioblastoma, marizomib was administered as a single agent or in combination with bevacizumab (NCT02330562). Based on encouraging observations, a phase I/II trial of marizomib in combination with Temozolomide+Radiotherapy(TMZ/RT) followed by Temozolomide (TMZ) in newly diagnosed glioblastoma has been launched (NCT02903069) which explores safety and tolerability of this triple combination and which shall help to determine the dose for further clinical trials in glioblastoma. In this context, given that marizomib has been established as a safe addition to the standard TMZ/RT --\\>TMZ, a phase III study is considered essential to establishing its impact on overall survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed newly diagnosed glioblastoma (WHO grade IV)\n* Tumor resection (gross total or partial), or biopsy only\n* Availability of formalin-fixed paraffin-embedded (FFPE) tumor block or 24 unstained slides for o6-methylguanine-DNA-methyltransferase (MGMT) analysis\n* Patient must be eligible for standard TMZ/RT + TMZ\n* Karnofsky performance score (KPS) ≥ 70\n* Recovered from effects of surgery, postoperative infection and other complications of surgery (if any)\n* The patient is at least 18 years of age on day of signing informed consent\n* Stable or decreasing dose of steroids for at least 1 week prior to inclusion\n* The patient has a life expectancy of at least 3 months\n* Patient has undergone a brain MRI within 14 days of randomization but after intervention (resection or biopsy)\n* The patient shows adequate organ functions as assessed by the specified laboratory values within 2 weeks prior to randomization defined as adequate bone marrow, renal and hepatic function within the following ranges:\n\n * white blood cell count (WBC) ≥ 3×10\\*9/L\n * absolute neutrophil count (ANC) ≥ 1.5×10\\*9/L\n * Platelet count of ≥ 100×10\\*9/L independent of transfusion\n * Hemoglobin ≥ 10 g/dl\n * Total Bilirubin ≤ 1.5 upper limit of normal (ULN)\n * Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤ 2.5 × ULN\n * Serum creatinine \\< 1.5 x ULN or creatinine clearance (CrCl) \\> 30 mL/min(using the Cockcroft-Gault formula)\n* Women of child bearing potential (WOCBP) must have a negative urine or serum pregnancy test within 7 days prior to the first dose of study treatment.\n* Patients of childbearing / reproductive potential must agree to use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 6 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1 percent per year) when used consistently and correctly. Patients must also agree not to donate sperm during the study and for 6 months after receiving the last dose of study treatment.\n* Women who are breast feeding must agree to discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment.\n* Ability to take oral medication\n* Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.\n* Before patient registration/randomization, written informed consent must be given according to International Council for Harmonisation (ICH) / Good clinical practice (GCP), and national/local regulations.'}, 'identificationModule': {'nctId': 'NCT03345095', 'acronym': 'MIRAGE', 'briefTitle': 'A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - 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