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Ignite Creation Date: 2025-12-24 @ 7:37 PM

Ignite Modification Date: 2026-02-22 @ 6:47 PM

Study NCT ID: NCT03149003

Status: COMPLETED

Last Update Posted: 2023-11-15

First Post: 2017-05-09

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy

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': '2022-12-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D009396', 'term': 'Wilms Tumor'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'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': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Sheila.dhaskali@oncology.sumitomo-pharma.com', 'phone': '617-674-6800', 'title': 'Sheila Dhaskali', 'organization': 'Sumitomo Pharma Oncology'}, 'certainAgreement': {'otherDetails': 'Institution shall submit to Sponsor for its review a copy of any proposed publication resulting from the study at least thirty days prior to the date of submission for publication. Sponsor shall complete its review within thirty days of its receipt of the proposed publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, up to 24 months.', 'description': 'In part 2 of the trial, 109 patients were randomized to arm 1, however 1 patient did not receive study drug and did not complete the trial. Therefore, the 108 patients in arm 1 who were randomized and received study drug were at risk for AEs or SAEs. In part 2 - arm 2, 108 patients were randomized, however 18 patients did not receive study drug and did not complete the trial. Therefore, the 90 patients in arm 2 who were randomized and received study drug were at risk for AEs or SAEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab', 'description': 'Drug: DSP-7888 Dosing Emulsion DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.\n\nOther Name: adegramotide and nelatimotide\n\nDrug: Bevacizumab Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg. Other Name: Avastin', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 4, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Part 2 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab', 'description': 'DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.\n\nBevacizumab: Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.', 'otherNumAtRisk': 108, 'deathsNumAtRisk': 109, 'otherNumAffected': 106, 'seriousNumAtRisk': 108, 'deathsNumAffected': 96, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'Part 2 - Arm 2: Bevacizumab', 'description': 'Bevacizumab: Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.', 'otherNumAtRisk': 90, 'deathsNumAtRisk': 108, 'otherNumAffected': 79, 'seriousNumAtRisk': 90, 'deathsNumAffected': 89, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 88}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Stridor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hyperacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 24}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 9}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'seriousEvents': [{'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Intracranial venous sinus thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Putamen haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypertensive encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Wound infection pseudomonas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tumour haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced a Dose-limiting Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab', 'description': 'Drug: DSP-7888 Dosing Emulsion DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.\n\nOther Name: adegramotide and nelatimotide\n\nDrug: Bevacizumab Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg. Other Name: Avastin'}, {'id': 'OG001', 'title': 'Part 2 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab', 'description': 'DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.\n\nBevacizumab: Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.'}, {'id': 'OG002', 'title': 'Part 2 - Arm 2: Bevacizumab', 'description': 'Bevacizumab: Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Dose-limiting toxicity will be evaluated and applied from Day 1 through Day 29', 'description': 'The number of participants with dose-limiting toxicity (DLT) who were enrolled into Part 1 - the safety set.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis limited to patients enrolled into Part 1 - the safety set.'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS) of Patients With Recurrent or Progressive Glioblastoma Multiforme (GBM) Treated With DSP-7888 Dosing Emulsion Plus Bevacizumab (BEV) Versus BEV Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab', 'description': 'Drug: DSP-7888 Dosing Emulsion DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.\n\nOther Name: adegramotide and nelatimotide\n\nDrug: Bevacizumab Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg. Other Name: Avastin'}, {'id': 'OG001', 'title': 'Part 2 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab', 'description': 'DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.\n\nBevacizumab: Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.'}, {'id': 'OG002', 'title': 'Part 2 - Arm 2: Bevacizumab', 'description': 'Bevacizumab: Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '11.4'}, {'value': '9.4', 'groupId': 'OG002', 'lowerLimit': '7.4', 'upperLimit': '10.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks after the patient has been off study treatment, every 3 months thereafter until death, the study closes, up to 24 months.', 'description': 'The effect of DSP-7888 Dosing Emulsion plus BEV versus BEV alone on the OS of patients with recurrent or progressive GBM following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis limited to patients randomized into Part 2 - the intent-to-treat set.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) of Patients With Recurrent or Progressive Glioblastoma Multiforme (GBM) Treated With DSP-7888 Dosing Emulsion Plus Bevacizumab (BEV) Versus BEV Alone at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab', 'description': 'Drug: DSP-7888 Dosing Emulsion DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.\n\nOther Name: adegramotide and nelatimotide\n\nDrug: Bevacizumab Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg. Other Name: Avastin'}, {'id': 'OG001', 'title': 'Part 2 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab', 'description': 'DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.\n\nBevacizumab: Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.'}, {'id': 'OG002', 'title': 'Part 2 - Arm 2: Bevacizumab', 'description': 'Bevacizumab: Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.9', 'groupId': 'OG001', 'lowerLimit': '28.7', 'upperLimit': '47.0'}, {'value': '31.6', 'groupId': 'OG002', 'lowerLimit': '22.9', 'upperLimit': '40.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'The effect of DSP-7888 dosing emulsion plus BEV versus BEV alone on the OS of patients with recurrent or progressive GBM following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis limited to patients randomized into Part 2 - the intent-to-treat set.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) of Patients With Recurrent or Progressive GBM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab', 'description': 'Drug: DSP-7888 Dosing Emulsion DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.\n\nOther Name: adegramotide and nelatimotide\n\nDrug: Bevacizumab Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg. Other Name: Avastin'}, {'id': 'OG001', 'title': 'Part 2 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab', 'description': 'DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.\n\nBevacizumab: Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.'}, {'id': 'OG002', 'title': 'Part 2 - Arm 2: Bevacizumab', 'description': 'Bevacizumab: Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '5.6'}, {'value': '3.8', 'groupId': 'OG002', 'lowerLimit': '3.7', 'upperLimit': '5.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause, up to 24 months', 'description': 'The effect of DSP-7888 dosing emulsion plus Bevacizumab (BEV) versus BEV alone on the Progression Free Survival (PFS) of patients with recurrent or progressive GBM following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy. PFS is defined as the interval between randomization and progression or death from any cause any cause as determined by the central radiology body.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis limited to patients randomized into Part 2 - the intent-to-treat set.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) Rate in Patients With Recurrent or Progressive GBM at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab', 'description': 'Drug: DSP-7888 Dosing Emulsion DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.\n\nOther Name: adegramotide and nelatimotide\n\nDrug: Bevacizumab Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg. Other Name: Avastin'}, {'id': 'OG001', 'title': 'Part 2 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab', 'description': 'DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.\n\nBevacizumab: Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.'}, {'id': 'OG002', 'title': 'Part 2 - Arm 2: Bevacizumab', 'description': 'Bevacizumab: Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.3', 'groupId': 'OG001', 'lowerLimit': '26.7', 'upperLimit': '46.0'}, {'value': '35.4', 'groupId': 'OG002', 'lowerLimit': '24.0', 'upperLimit': '47.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause at 6 months', 'description': 'The effect of DSP-7888 dosing emulsion plus Bevacizumab (BEV) versus BEV alone on the Progression Free Survival (PFS) rate in patients with recurrent or progressive GBM following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy. PFS is defined as the interval between randomization date and progression or death from any cause as determined by the central radiology body. The percentage of patients who achieved PFS at 6 months are summarized.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis limited to patients randomized into Part 2 - the intent-to-treat set.'}, {'type': 'SECONDARY', 'title': 'The Effect of DSP-7888 Dosing Emulsion Plus Bevacizumab (BEV) Versus BEV Alone on the Response Rate of Patients With Recurrent or Progressive GBM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab', 'description': 'Drug: DSP-7888 Dosing Emulsion DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.\n\nOther Name: adegramotide and nelatimotide\n\nDrug: Bevacizumab Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg. Other Name: Avastin'}, {'id': 'OG001', 'title': 'Part 2 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab', 'description': 'DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.\n\nBevacizumab: Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.'}, {'id': 'OG002', 'title': 'Part 2 - Arm 2: Bevacizumab', 'description': 'Bevacizumab: Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG001', 'lowerLimit': '13.9', 'upperLimit': '30.0'}, {'value': '13.0', 'groupId': 'OG002', 'lowerLimit': '7.3', 'upperLimit': '20.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 months', 'description': 'Assessment of the objective response rate (ORR) of DSP-7888 dosing emulsion plus BEV versus BEV alone in patients with recurrent or progressive GBM. The response rate is defined as the percentage of patients exhibiting a response (complete response \\[CR\\] plus partial response \\[PR\\]) based on the Modified Response Assessment in Neuro-Oncology (RANO) criteria as determined by the central radiology body.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis limited to patients randomized into Part 2 - the intent-to-treat set.'}, {'type': 'SECONDARY', 'title': 'Duration of Response in Patients With Recurrent or Progressive GBM Treated With DSP-7888 Dosing Emulsion Plus Bevacizumab (BEV) Versus BEV Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab', 'description': 'Drug: DSP-7888 Dosing Emulsion DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.\n\nOther Name: adegramotide and nelatimotide\n\nDrug: Bevacizumab Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg. Other Name: Avastin'}, {'id': 'OG001', 'title': 'Part 2 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab', 'description': 'DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.\n\nBevacizumab: Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.'}, {'id': 'OG002', 'title': 'Part 2 - Arm 2: Bevacizumab', 'description': 'Bevacizumab: Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.81', 'spread': '7.119', 'groupId': 'OG001'}, {'value': '3.69', 'spread': '4.017', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the date of first treatment up to 24 months', 'description': 'The effect of DSP-7888 dosing emulsion plus BEV versus BEV alone on the duration of response of patients with recurrent or progressive GBM. The duration of response is defined as the interval between first documented oncological response and progression of disease or death from any cause.', 'unitOfMeasure': 'months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis limited to patients randomized into Part 2 - the intent-to-treat set. NE signifies "Not Estimable" in the results.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events and Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab', 'description': 'Drug: DSP-7888 Dosing Emulsion DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.\n\nOther Name: adegramotide and nelatimotide\n\nDrug: Bevacizumab Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg. Other Name: Avastin'}, {'id': 'OG001', 'title': 'Part 2 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab', 'description': 'DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.\n\nBevacizumab: Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.'}, {'id': 'OG002', 'title': 'Part 2 - Arm 2: Bevacizumab', 'description': 'Bevacizumab: Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'The time from the date of first treatment, while the patient is on treatment, and for 30 days after stopping therapy, an average of 4 months', 'description': 'Assessment of safety of DSP7888 dosing emulsion plus Bevacizumab (BEV) versus BEV alone in patients with recurrent or progressive GBM', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab', 'description': 'Drug: DSP-7888 Dosing Emulsion DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.\n\nOther Name: adegramotide and nelatimotide\n\nDrug: Bevacizumab Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg. Other Name: Avastin'}, {'id': 'FG001', 'title': 'Part 2 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab', 'description': 'DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.\n\nBevacizumab: Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.'}, {'id': 'FG002', 'title': 'Part 2 - Arm 2: Bevacizumab', 'description': 'Bevacizumab: Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '109'}, {'groupId': 'FG002', 'numSubjects': '108'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '108'}, {'groupId': 'FG002', 'numSubjects': '90'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '18'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '221', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab', 'description': 'Drug: DSP-7888 Dosing Emulsion DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.\n\nOther Name: adegramotide and nelatimotide\n\nDrug: Bevacizumab Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg. Other Name: Avastin'}, {'id': 'BG001', 'title': 'Part 2 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab', 'description': 'DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.\n\nBevacizumab: Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.'}, {'id': 'BG002', 'title': 'Part 2 - Arm 2: Bevacizumab', 'description': 'Bevacizumab: Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.'}, {'id': 'BG003', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Native Aboriginal (including First Nations, Metis, Inuit)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '133', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}]}]}, {'title': 'Black (including African, Caribbean descent)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Native Americans or Alaskan Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HLA Class I Type', 'classes': [{'categories': [{'title': 'HLA-A*02 Positive Only', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '132', 'groupId': 'BG003'}]}, {'title': 'HLA-A*24 Positive Only', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}, {'title': 'Both Positive', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-05', 'size': 1641171, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-09-27T13:58', 'hasProtocol': True}, {'date': '2021-11-01', 'size': 819969, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-09-27T14:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 221}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-13', 'studyFirstSubmitDate': '2017-05-09', 'resultsFirstSubmitDate': '2022-11-08', 'studyFirstSubmitQcDate': '2017-05-09', 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-04', 'studyFirstPostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experienced a Dose-limiting Toxicity', 'timeFrame': 'Dose-limiting toxicity will be evaluated and applied from Day 1 through Day 29', 'description': 'The number of participants with dose-limiting toxicity (DLT) who were enrolled into Part 1 - the safety set.'}, {'measure': 'Overall Survival (OS) of Patients With Recurrent or Progressive Glioblastoma Multiforme (GBM) Treated With DSP-7888 Dosing Emulsion Plus Bevacizumab (BEV) Versus BEV Alone', 'timeFrame': '4 weeks after the patient has been off study treatment, every 3 months thereafter until death, the study closes, up to 24 months.', 'description': 'The effect of DSP-7888 Dosing Emulsion plus BEV versus BEV alone on the OS of patients with recurrent or progressive GBM following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS) of Patients With Recurrent or Progressive Glioblastoma Multiforme (GBM) Treated With DSP-7888 Dosing Emulsion Plus Bevacizumab (BEV) Versus BEV Alone at 12 Months', 'timeFrame': '12 months', 'description': 'The effect of DSP-7888 dosing emulsion plus BEV versus BEV alone on the OS of patients with recurrent or progressive GBM following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy.'}, {'measure': 'Progression Free Survival (PFS) of Patients With Recurrent or Progressive GBM', 'timeFrame': 'The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause, up to 24 months', 'description': 'The effect of DSP-7888 dosing emulsion plus Bevacizumab (BEV) versus BEV alone on the Progression Free Survival (PFS) of patients with recurrent or progressive GBM following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy. PFS is defined as the interval between randomization and progression or death from any cause any cause as determined by the central radiology body.'}, {'measure': 'Progression Free Survival (PFS) Rate in Patients With Recurrent or Progressive GBM at 6 Months', 'timeFrame': 'The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause at 6 months', 'description': 'The effect of DSP-7888 dosing emulsion plus Bevacizumab (BEV) versus BEV alone on the Progression Free Survival (PFS) rate in patients with recurrent or progressive GBM following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy. PFS is defined as the interval between randomization date and progression or death from any cause as determined by the central radiology body. The percentage of patients who achieved PFS at 6 months are summarized.'}, {'measure': 'The Effect of DSP-7888 Dosing Emulsion Plus Bevacizumab (BEV) Versus BEV Alone on the Response Rate of Patients With Recurrent or Progressive GBM', 'timeFrame': 'From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 months', 'description': 'Assessment of the objective response rate (ORR) of DSP-7888 dosing emulsion plus BEV versus BEV alone in patients with recurrent or progressive GBM. The response rate is defined as the percentage of patients exhibiting a response (complete response \\[CR\\] plus partial response \\[PR\\]) based on the Modified Response Assessment in Neuro-Oncology (RANO) criteria as determined by the central radiology body.'}, {'measure': 'Duration of Response in Patients With Recurrent or Progressive GBM Treated With DSP-7888 Dosing Emulsion Plus Bevacizumab (BEV) Versus BEV Alone', 'timeFrame': 'From the date of first treatment up to 24 months', 'description': 'The effect of DSP-7888 dosing emulsion plus BEV versus BEV alone on the duration of response of patients with recurrent or progressive GBM. The duration of response is defined as the interval between first documented oncological response and progression of disease or death from any cause.'}, {'measure': 'Number of Participants With Adverse Events and Serious Adverse Events', 'timeFrame': 'The time from the date of first treatment, while the patient is on treatment, and for 30 days after stopping therapy, an average of 4 months', 'description': 'Assessment of safety of DSP7888 dosing emulsion plus Bevacizumab (BEV) versus BEV alone in patients with recurrent or progressive GBM'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glioblastoma (GBM)', 'Wilms Tumor 1 (WT1)', 'Cancer Vaccines', 'Neoplasms', 'Astrocytoma', 'Glioma', 'Brain Cancer', 'Brain Tumor', 'Bevacizumab'], 'conditions': ['Glioblastoma']}, 'descriptionModule': {'briefSummary': 'This is an event driven, adaptive design, a randomized, active-controlled, multicenter, open-label, parallel groups, Phase 3 study of DSP-7888 Dosing Emulsion plus Bevacizumab versus Bevacizumab alone in patients with recurrent or progressive glioblastoma multiforme (GBM) following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients or their legal representatives must be able to provide written informed consent.\n* Histologically confirmed diagnosis of supratentorial GBM (Grade 4 astrocytoma).\n* Radiographic evidence of first recurrence or progression of GBM following primary therapy consisting of surgery (biopsy or resection) and chemoradiation; patients may have undergone a second debulking surgery following initial recurrence or progression. Patients whose tumors are O6 methyl guanyl-methyltransferase (MGMT) methylated-promoter negative need not have received chemotherapy in the past to be eligible.\n* Human leukocyte antigen type HLA-A\\*02:01, HLA-A\\*02:06, or HLA-A\\*24:02.\n* Age ≥18.\n* KPS score of ≥60.\n* Serum creatinine value \\<2X the upper limit of normal (ULN) for the reference laboratory.\n* Alanine aminotransferase/aspartate aminotransferase \\<3X the ULN and total bilirubin \\<2× the ULN for the reference laboratory.\n* Men and women of childbearing potential must agree to use a reliable method of contraception (oral contraceptives, implantable hormonal contraceptives, or double barrier method) or agree to completely refrain from heterosexual intercourse for the duration of the study and for 180 days following the last dose of DSP-7888 Dosing Emulsion.\n* Patients must have recovered from the effect of all prior therapy to Grade 2 or less.\n* Patients must be at least 28 days from any major surgery, and any surgery incisions or wounds must be completely healed.\n* Patients must be at least 12 weeks from the completion of prior radiation therapy (RT) in order to discriminate pseudo progression of disease from progression.\n* Patients must be at least 4 weeks from the completion of prior systemic or intracranial chemotherapy.\n* Patients must stop Novo-TTF treatment one day prior to study therapy (no washout period is needed). However, any wounds from TTF must be adequately healed per Inclusion Criterion #11.15. For patients who are not receiving therapeutic anticoagulation treatment, an international normalized ratio (INR) and a PTT ≤ 1.5 × the ULN; patients who are receiving anticoagulation treatment should be on a stable dose.\n* Patient's left ventricular ejection fraction (LVEF) \\> 40%. 17. Patient has a resting pulse oximetry of 90% or higher.\n\nExclusion Criteria:\n\nPatients with any of the following will be excluded from the study:\n\n* Prior therapy with Bev.\n* Patients with secondary GBM.\n* Any anti-neoplastic therapy, including RT, for first relapse or recurrence.\n* Evidence of leptomeningeal spread of tumor or any history, presence, or suspicion of metastatic disease extracranially.\n* Evidence of impending herniation on imaging.\n* Has known multifocal disease. Multifocal disease is defined as discrete sites of disease without contiguous T2/FLAIR abnormality that require distinct radiotherapy ports. Satellite lesions that are associated with a contiguous area of T2/FLAIR abnormality as the main lesion(s) and that are encompassed within the same radiotherapy port as the main lesion(s) are permitted.\n* Patients with infections that have required treatment with systemic antibiotics within 7 days of first dose of protocol therapy.\n* The need for systemic glucocorticoids in doses in excess of 4 mg/day of dexamethasone or in comparable doses with other glucocorticoids.\n* Treatment with any investigational agents within 5 half-lives of the agent in question or, if the half-life is unknown, within 28 days of enrollment.\n* Pregnant or lactating females.\n* Prior history of malignancy within 3 years of enrollment other than basal or squamous cell carcinoma of the skin, cervical intra-epithelial neoplasia, in situ carcinoma of the breast, or prostate cancer treated with surgery or RT with a prostate specific antigen of \\<0.01 ng/mL.\n* Patients with active autoimmune diseases within 2 years of enrollment into the study including, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, Sjogren's syndrome, Wegener's granulomatosis, ulcerative colitis, Crohn's disease, myasthenia gravis, Graves' disease, or uveitis except for psoriasis not requiring systemic therapy, vitiligo or alopecia areata, or hypothyroidism; if an autoimmune condition has been clinically silent for 12 months or greater, the patient may be eligible for enrollment.\n* Patients on immunosuppressive therapies; the use of topical, inhalational, ophthalmologic or intra articular glucocorticoids, or the use of physiologic replacement doses of glucocorticoids are permitted.\n* Patients with primary immunodeficiency diseases.\n* Patients with significant bleeding in the preceding 6 months or with known coagulopathies.\n* History of abdominal fistula, intestinal perforation, or intra-abdominal abscess in the preceding 12 months.\n* Positive serology for human immunodeficiency virus (HIV) infection, active hepatitis B\\*, or untreated hepatitis C; patients who have completed a course of anti-viral treatment for hepatitis C are eligible.\n\n o \\*In cases of negative results for HepB surface antigen with positive HepB core antibody, HBV DNA testing is required.\n* Patient has a medical history of frequent ventricular ectopy, e.g., non-sustained ventricular tachycardia (VT).\n* Significant cardiovascular disease, including New York Hospital Association Class III or IV congestive heart failure, myocardial infarction within 6 months of enrollment, unstable angina, poorly controlled cardiac arrhythmias, or stroke within the preceding 6 months.\n* Any other uncontrolled inter current medical condition, including systemic fungal, bacterial, or viral infection; uncontrolled hypertension; diabetes mellitus; or chronic obstructive pulmonary disease requiring 2 or more hospitalizations in the preceding 12 months.\n* Any psychiatric condition, substance abuse disorder, or social situation that would interfere with a patient's cooperation with the requirements of the study.\n* Known sensitivity to Bev or any of the components of DSP-7888 Dosing Emulsion.\n* Patient has a QTcF (QT corrected based on Fridericia's equation) interval \\> 480 msec (CTCAE = Grade 2) or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) at screening. (Patients with bundle branch block and a prolonged QTc interval should be reviewed by the Medical Monitor for potential inclusion.)\n* Patient has dyspnea at rest (CTCAE ≥ Grade 3) or has required supplemental oxygen within 2 weeks of study enrollment."}, 'identificationModule': {'nctId': 'NCT03149003', 'briefTitle': 'A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sumitomo Pharma America, Inc.'}, 'officialTitle': 'A Randomized, Multicenter, Adaptive Phase 3 Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab Versus Bevacizumab Alone in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy (WIZARD 201G)', 'orgStudyIdInfo': {'id': 'BBI-DSP7888-201G'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: DSP-7888 Dosing Emulsion plus Bevacizumab', 'interventionNames': ['Drug: DSP-7888 Dosing Emulsion', 'Drug: Bevacizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2: Bevacizumab', 'interventionNames': ['Drug: Bevacizumab']}], 'interventions': [{'name': 'DSP-7888 Dosing Emulsion', 'type': 'DRUG', 'otherNames': ['adegramotide and nelatimotide'], 'description': 'DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.', 'armGroupLabels': ['Arm 1: DSP-7888 Dosing Emulsion plus Bevacizumab']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.', 'armGroupLabels': ['Arm 1: DSP-7888 Dosing Emulsion plus Bevacizumab', 'Arm 2: Bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': 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