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Ignite Creation Date: 2025-12-24 @ 7:57 PM

Ignite Modification Date: 2025-12-29 @ 10:15 PM

Study NCT ID: NCT01137604

Status: COMPLETED

Last Update Posted: 2022-09-29

First Post: 2010-06-02

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: A Study in Subjects With Recurrent Malignant Glioma

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}], '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': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531958', 'term': 'lenvatinib'}, {'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': 'esi_medinfo@eisai.com', 'phone': '1-888-422-4743', 'title': 'Eisai Medical Services', 'organization': 'Eisai, Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'For each participant, from the first patient first dose till 30 days after the last dose or the cut-off date of 19 March 2013 (ie, 2.4 years)', 'description': 'All participants were followed for survival until death, except where a participant withdrew consent, or the Sponsor stopped the survival follow-up during the extension phase after completion of the primary study analysis. Since death was not a protocol defined reason for non-completion, the all cause mortality data below are not reflected in the Participant Flow section.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1 - Bevacizumab', 'description': 'Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \\[GBM\\]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 38, 'seriousNumAtRisk': 38, 'deathsNumAffected': 36, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Cohort 1 - Lenvatinib', 'description': 'Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \\[GBM\\]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 40, 'seriousNumAtRisk': 42, 'deathsNumAffected': 38, 'seriousNumAffected': 22}, {'id': 'EG002', 'title': 'Cohort 2 - Lenvatinib', 'description': 'Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 39, 'seriousNumAtRisk': 39, 'deathsNumAffected': 27, 'seriousNumAffected': 12}, {'id': 'EG003', 'title': 'Cohort 3 - Lenvatinib', 'description': 'Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 31, 'seriousNumAtRisk': 32, 'deathsNumAffected': 30, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Splinter haemorrhages', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Faecal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Tongue ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Candida infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 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1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Myopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Tumour haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Hemianopia homonymous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Pyramidal tract syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Rectal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA version 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Bevacizumab', 'description': 'Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \\[GBM\\]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles'}, {'id': 'OG001', 'title': 'Cohort 1 - Lenvatinib', 'description': 'Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \\[GBM\\]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}, {'id': 'OG002', 'title': 'Cohort 2 - Lenvatinib', 'description': 'Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}, {'id': 'OG003', 'title': 'Cohort 3 - Lenvatinib', 'description': 'Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '31.3'}, {'value': '21.4', 'groupId': 'OG001', 'lowerLimit': '10.3', 'upperLimit': '36.8'}, {'value': '7.7', 'groupId': 'OG002', 'lowerLimit': '1.6', 'upperLimit': '20.9'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (i.e., 2.4 years)', 'description': "ORR was the percentage of participants with best overall response (BOR) of complete response (CR) and partial response (PR) based on RANO criteria and investigator's assessment. CR was defined as the disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks, no new lesions, and stable or improved non-enhancing (T2/FLAIR) lesions. PR was defined as greater than or equal to 50% decrease, compared to baseline, in the sum of products of perpendicular diameters of all measureable enhancing lesions sustained for at least 4 weeks. No progression of non-measurable disease, no new lesions, stable or improved non-enhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared to baseline. For both CR and PR, in the absence of a confirming scan 4 weeks later, this scan was considered only stable disease. Only participants with measureable disease at baseline were included in evaluation of ORR.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set included all participants who received at least one dose of study drug'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Bevacizumab', 'description': 'Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \\[GBM\\]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles'}, {'id': 'OG001', 'title': 'Cohort 1 - Lenvatinib', 'description': 'Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \\[GBM\\]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}, {'id': 'OG002', 'title': 'Cohort 2 - Lenvatinib', 'description': 'Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}, {'id': 'OG003', 'title': 'Cohort 3 - Lenvatinib', 'description': 'Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '3.6'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '3.6'}, {'value': '2.8', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '3.7'}, {'value': '1.8', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '2.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years)', 'description': "PFS was measured as the time from randomization (Cohort 1) or the first day of treatment (Cohorts 2 and 3) until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression, based on investigator's assessment.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - all participants who received at least one dose of study drug'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Bevacizumab', 'description': 'Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \\[GBM\\]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles'}, {'id': 'OG001', 'title': 'Cohort 1 - Lenvatinib', 'description': 'Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \\[GBM\\]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}, {'id': 'OG002', 'title': 'Cohort 2 - Lenvatinib', 'description': 'Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}, {'id': 'OG003', 'title': 'Cohort 3 - Lenvatinib', 'description': 'Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '7.7'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '11.6'}, {'value': '12.0', 'comment': 'NA= Not applicable as it is not evaluable.', 'groupId': 'OG002', 'lowerLimit': '8.4', 'upperLimit': 'NA'}, {'value': '4.1', 'groupId': 'OG003', 'lowerLimit': '3.0', 'upperLimit': '5.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until death due to any cause or up to data cutoff date of 19 March 2013 (ie, 2.4 years)', 'description': 'OS was measured as the time from the randomization date (Cohort 1) or the first day of treatment (Cohort 2 and 3) to the date of death from any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - all participants who received at least one dose of study drug'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Bevacizumab', 'description': 'Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \\[GBM\\]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles'}, {'id': 'OG001', 'title': 'Cohort 1 - Lenvatinib', 'description': 'Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \\[GBM\\]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}, {'id': 'OG002', 'title': 'Cohort 2 - Lenvatinib', 'description': 'Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}, {'id': 'OG003', 'title': 'Cohort 3 - Lenvatinib', 'description': 'Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '57.9', 'groupId': 'OG000', 'lowerLimit': '40.8', 'upperLimit': '73.7'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '34.2', 'upperLimit': '65.8'}, {'value': '48.7', 'groupId': 'OG002', 'lowerLimit': '32.4', 'upperLimit': '65.2'}, {'value': '28.1', 'groupId': 'OG003', 'lowerLimit': '13.7', 'upperLimit': '46.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years)', 'description': "DCR was the percentage of the participants who had BOR of CR, PR, and stable disease (SD) with the minimum duration of SD lasting greater than or equal to 7 weeks. Only participants with measurable disease at baseline were included in evaluation of DCR, based on investigator's assessment.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - all participants who received at least one dose of study drug'}, {'type': 'SECONDARY', 'title': 'Clinical Benefit Rate (CBR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Bevacizumab', 'description': 'Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \\[GBM\\]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles'}, {'id': 'OG001', 'title': 'Cohort 1 - Lenvatinib', 'description': 'Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \\[GBM\\]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}, {'id': 'OG002', 'title': 'Cohort 2 - Lenvatinib', 'description': 'Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}, {'id': 'OG003', 'title': 'Cohort 3 - Lenvatinib', 'description': 'Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '31.3'}, {'value': '26.2', 'groupId': 'OG001', 'lowerLimit': '13.9', 'upperLimit': '42.0'}, {'value': '17.9', 'groupId': 'OG002', 'lowerLimit': '7.5', 'upperLimit': '33.5'}, {'value': '6.3', 'groupId': 'OG003', 'lowerLimit': '0.8', 'upperLimit': '20.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years)', 'description': "CBR was the percentage of the participants who had BOR of CR, PR, and SD with the minimum duration of SD lasting greater than or equal to 23 weeks. Only participants with measurable disease at baseline were included in evaluation of CBR, based on investigator's assessment.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - all participants who received at least one dose of study drug'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs)/Serious Adverse Events (SAEs) as a Measure of Safety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Bevacizumab', 'description': 'Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \\[GBM\\]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles'}, {'id': 'OG001', 'title': 'Cohort 1 - Lenvatinib', 'description': 'Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \\[GBM\\]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}, {'id': 'OG002', 'title': 'Cohort 2 - Lenvatinib', 'description': 'Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}, {'id': 'OG003', 'title': 'Cohort 3 - Lenvatinib', 'description': 'Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'For each participant, from the first patient first dose till 30 days after the last dose or the cut-off date of 19 March 2013 (ie, 2.4 years)', 'description': 'Safety was assessed by monitoring and recording all AEs including all Common Terminology Criteria for Adverse Events (CTCAE) grades (for both increasing and decreasing severity) and SAEs; regular monitoring of hematology, clinical chemistry, and urine values; results of physical examinations, regular measurement of vital signs, and electrocardiograms (ECGs), as detailed in the Schedule of Visits and Procedures. The relationship of AEs to treatment was based on investigator judgment. Details of AEs and SAEs are provided in the reported adverse event section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - all participants who received at least one dose of study drug'}, {'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS) Rate at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Bevacizumab', 'description': 'Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \\[GBM\\]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles'}, {'id': 'OG001', 'title': 'Cohort 1 - Lenvatinib', 'description': 'Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \\[GBM\\]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}, {'id': 'OG002', 'title': 'Cohort 2 - Lenvatinib', 'description': 'Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}, {'id': 'OG003', 'title': 'Cohort 3 - Lenvatinib', 'description': 'Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '23.4'}, {'value': '21.2', 'groupId': 'OG001', 'lowerLimit': '10.4', 'upperLimit': '34.5'}, {'value': '8.0', 'groupId': 'OG002', 'lowerLimit': '1.6', 'upperLimit': '21.6'}, {'value': '7.6', 'groupId': 'OG003', 'lowerLimit': '1.3', 'upperLimit': '21.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 6 from randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3)', 'description': "PFS at Month 6 was defined as the percentage of participants who remained alive and progression-free at Month 6, based on investigator's assessment. Progression was defined using Response Assessment in Neuro-Oncology (RANO) criteria, as a greater than 25% increase in enhancing lesions despite stable or increasing steroid dose, an increase (significant) in non-enhancing T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR) lesions that are not attributable to other non-tumor causes, and any new lesions. PFS rate at Month 6 was estimated from Kaplan-Meier (K-M) product-limit estimate of PFS.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set included all participants who received at least one dose of study drug'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1 - Bevacizumab', 'description': 'Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \\[GBM\\]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles'}, {'id': 'FG001', 'title': 'Cohort 1 - Lenvatinib', 'description': 'Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \\[GBM\\]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}, {'id': 'FG002', 'title': 'Cohort 2 - Lenvatinib', 'description': 'Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}, {'id': 'FG003', 'title': 'Cohort 3 - Lenvatinib', 'description': 'Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '39 participants were randomized but 1 participant died prior to receiving treatment.', 'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '32'}]}, {'type': 'Treatment Discontinued Due to Disease Progression', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Participant Choice', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal of consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Clinical progression/deterioration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 173 participants were screened and of those, 152 participants were deemed eligible, and 151 received study treatment.', 'preAssignmentDetails': 'The protocol definition of study completion was that the participant had disease progression. Protocol defined reasons for not completing were adverse event, participant choice, lost to follow-up, administrative/other (including withdrawal of consent, pregnancy, study terminated by sponsor or other). Death was not a protocol defined reason for non-completion. Participants were followed for survival until death, except where they withdrew consent, or the Sponsor stopped the survival follow-up.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '151', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1 - Bevacizumab', 'description': 'Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \\[GBM\\]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles'}, {'id': 'BG001', 'title': 'Cohort 1 - Lenvatinib', 'description': 'Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \\[GBM\\]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}, {'id': 'BG002', 'title': 'Cohort 2 - Lenvatinib', 'description': 'Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}, {'id': 'BG003', 'title': 'Cohort 3 - Lenvatinib', 'description': 'Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.1', 'spread': '10.61', 'groupId': 'BG000'}, {'value': '55.5', 'spread': '11.96', 'groupId': 'BG001'}, {'value': '49.2', 'spread': '11.35', 'groupId': 'BG002'}, {'value': '53.0', 'spread': '11.15', 'groupId': 'BG003'}, {'value': '52.6', 'spread': '11.74', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '101', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'World Health Organization Grading for Gliomas', 'classes': [{'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '112', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-30', 'studyFirstSubmitDate': '2010-06-02', 'resultsFirstSubmitDate': '2015-03-13', 'studyFirstSubmitQcDate': '2010-06-03', 'lastUpdatePostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-05-20', 'studyFirstPostDateStruct': {'date': '2010-06-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS) Rate at Month 6', 'timeFrame': 'At Month 6 from randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3)', 'description': "PFS at Month 6 was defined as the percentage of participants who remained alive and progression-free at Month 6, based on investigator's assessment. Progression was defined using Response Assessment in Neuro-Oncology (RANO) criteria, as a greater than 25% increase in enhancing lesions despite stable or increasing steroid dose, an increase (significant) in non-enhancing T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR) lesions that are not attributable to other non-tumor causes, and any new lesions. PFS rate at Month 6 was estimated from Kaplan-Meier (K-M) product-limit estimate of PFS."}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (i.e., 2.4 years)', 'description': "ORR was the percentage of participants with best overall response (BOR) of complete response (CR) and partial response (PR) based on RANO criteria and investigator's assessment. CR was defined as the disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks, no new lesions, and stable or improved non-enhancing (T2/FLAIR) lesions. PR was defined as greater than or equal to 50% decrease, compared to baseline, in the sum of products of perpendicular diameters of all measureable enhancing lesions sustained for at least 4 weeks. No progression of non-measurable disease, no new lesions, stable or improved non-enhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared to baseline. For both CR and PR, in the absence of a confirming scan 4 weeks later, this scan was considered only stable disease. Only participants with measureable disease at baseline were included in evaluation of ORR."}, {'measure': 'Progression Free Survival', 'timeFrame': 'From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years)', 'description': "PFS was measured as the time from randomization (Cohort 1) or the first day of treatment (Cohorts 2 and 3) until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression, based on investigator's assessment."}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until death due to any cause or up to data cutoff date of 19 March 2013 (ie, 2.4 years)', 'description': 'OS was measured as the time from the randomization date (Cohort 1) or the first day of treatment (Cohort 2 and 3) to the date of death from any cause.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years)', 'description': "DCR was the percentage of the participants who had BOR of CR, PR, and stable disease (SD) with the minimum duration of SD lasting greater than or equal to 7 weeks. Only participants with measurable disease at baseline were included in evaluation of DCR, based on investigator's assessment."}, {'measure': 'Clinical Benefit Rate (CBR)', 'timeFrame': 'From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years)', 'description': "CBR was the percentage of the participants who had BOR of CR, PR, and SD with the minimum duration of SD lasting greater than or equal to 23 weeks. Only participants with measurable disease at baseline were included in evaluation of CBR, based on investigator's assessment."}, {'measure': 'Number of Participants With Adverse Events (AEs)/Serious Adverse Events (SAEs) as a Measure of Safety', 'timeFrame': 'For each participant, from the first patient first dose till 30 days after the last dose or the cut-off date of 19 March 2013 (ie, 2.4 years)', 'description': 'Safety was assessed by monitoring and recording all AEs including all Common Terminology Criteria for Adverse Events (CTCAE) grades (for both increasing and decreasing severity) and SAEs; regular monitoring of hematology, clinical chemistry, and urine values; results of physical examinations, regular measurement of vital signs, and electrocardiograms (ECGs), as detailed in the Schedule of Visits and Procedures. The relationship of AEs to treatment was based on investigator judgment. Details of AEs and SAEs are provided in the reported adverse event section.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glioma']}, 'descriptionModule': {'briefSummary': 'An open-label phase 2, multicenter study in participants with recurrent malignant glioma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Histologically confirmed diagnosis of Grade 3 or 4 malignant glioma.\n2. All subjects who have a first or second recurrence following primary management with surgical resection or biopsy, radiotherapy and up to 2 prior systemic treatments with addition of:\n\n * No prior bevacizumab treatment is allowed for Cohort 1 and Cohort 2.\n * Subjects must have disease progression following prior bevacizumab treatment for Cohort 3.\n * For all cohorts, no prior anti-vascular endothelial growth factor (VEGF/VEGFR) therapy except for bevacizumab as specified above.\n3. Karnofsky score of 70% or greater.\n4. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than 150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the Screening Visit.\n5. Adequate renal function, adequate bone marrow function, adequate blood coagulation function and adequate liver function, as defined in protocol.\n6. No evidence of hemorrhage on the baseline magnetic resonance imaging (MRI) scan other than in those subjects who are stable grade 1.\n\nExclusion criteria:\n\n1. Females who are pregnant or breastfeeding.\n2. Subjects who received enzyme-inducing anti-epileptic agents within 14 days before the first dose of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone, or oxcarbazepine).\n3. Active infection requiring intravenous antibiotics.\n4. Therapeutic anti-coagulation with warfarin, aspirin, nonsteroidal anti-inflammatory drugs or clopidogrel (low molecular weight heparin is acceptable).\n5. Subjects with 24-hour urine protein greater than or equal to 1 gm.\n6. Prior surgical resection within 4 weeks, or prior stereotactic biopsy within 2 weeks, of Screening Visit.\n7. Prior radiotherapy within 12 weeks unless there is a new area of enhancement consistent with recurrent tumor outside of the radiation field, or there is biopsy-proven unequivocal viable tumor on histopathologic sampling.\n8. Prior chemotherapy (6 weeks for nitrosoureas), or any investigational agent within 4 weeks unless the subject has recovered from all anticipated toxicities associated with that therapy; prior bevacizumab therapy (Cohorts 1 and 2); for Cohort 3, prior bevacizumab therapy within 3 weeks.\n9. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II ; unstable angina; myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment.\n10. Prolongation of QTc interval to greater than 480 msec.\n11. Active hemoptysis (bright red blood of at least 1/2 teaspoon) within 3 weeks prior to the first dose of study drug.'}, 'identificationModule': {'nctId': 'NCT01137604', 'briefTitle': 'A Study in Subjects With Recurrent Malignant Glioma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'An Open-Label, Three-Cohort, Phase 2 Study of E7080 (Lenvatinib) in Subjects With Recurrent Malignant Glioma', 'orgStudyIdInfo': {'id': 'E7080-G000-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Cohort 1 assessed participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \\[GBM\\]) who were bevacizumab-naive. Participants were planned to be accrued in Cohort 1 and randomized in a 1:1 ratio to receive lenvatinib (experimental) or bevacizumab (active comparator).\n\nCohort 1 - Bevacizumab\n\nCohort 1 - Lenvatinib', 'interventionNames': ['Drug: Lenvatinib', 'Drug: Bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Cohort 2 assessed participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive. Participants in Cohort 2 were planned to be treated with lenvatinib.', 'interventionNames': ['Drug: Lenvatinib']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'Cohort 3 assessed participants with recurrent GBM who had disease progression following prior bevacizumab treatment. Participants in Cohort 3 were planned to be treated with lenvatinib.', 'interventionNames': ['Drug: Lenvatinib']}], 'interventions': [{'name': 'Lenvatinib', 'type': 'DRUG', 'otherNames': ['E7080'], 'description': '24 mg lenvatinib capsules orally, once daily continuously in 28-day cycles until disease progression, development of unacceptable toxicity or withdrawal of consent.', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'Bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles until disease progression, development of unacceptable toxicity or withdrawal of consent.', 'armGroupLabels': ['Cohort 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Calgary', 'country': 'Canada', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Toronto', 'country': 'Canada', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Eisai Medical Services', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eisai Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}