Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-27 @ 10:20 PM
Study NCT ID:
NCT00510068
Status:
COMPLETED
Last Update Posted:
2015-07-01
First Post:
2007-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Everolimus (RAD001) Compared to Placebo in Patients With Advanced Neuroendocrine Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068338', 'term': 'Everolimus'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Everolimus 10mg/Day', 'description': 'Afinitor DB: Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).', 'otherNumAtRisk': 204, 'otherNumAffected': 201, 'seriousNumAtRisk': 204, 'seriousNumAffected': 84}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).', 'otherNumAtRisk': 203, 'otherNumAffected': 190, 'seriousNumAtRisk': 203, 'seriousNumAffected': 52}, {'id': 'EG002', 'title': 'Open Label - Everolimus 10mg', 'description': 'Afinitor OL (for data collected in the open-label period of the study): The open-label set included only patients who received at least one dose of open-label everolimus 10 mg and had at least one safety assessment during the open-label period of the study.', 'otherNumAtRisk': 225, 'otherNumAffected': 218, 'seriousNumAtRisk': 225, 'seriousNumAffected': 108}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 55}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 55}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 96}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 80}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 105}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 70}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 73}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 66}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 57}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 38}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 28}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 72}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 64}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 58}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 34}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 40}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 22}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 18}], 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'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Stasis dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Aneurysm ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus 10 mg/Day', 'description': 'Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).'}], 'classes': [{'categories': [{'measurements': [{'value': '11.04', 'groupId': 'OG000', 'lowerLimit': '8.41', 'upperLimit': '13.86'}, {'value': '4.60', 'groupId': 'OG001', 'lowerLimit': '3.06', 'upperLimit': '5.39'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010', 'description': 'Progression of disease is defined as the time from study start to the date of first documented progression of disease or death due to any cause. Progression of disease is defined by RECIST criteria: Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all patients who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response Rate ( CR {Complete Response} OR PR {Partial Response})', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus 10 mg/Day', 'description': 'Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '8.7'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '5.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010', 'description': 'Objective Response defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of the longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks . Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all patients who were randomized.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus 10 mg/Day', 'description': 'Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).'}], 'classes': [{'categories': [{'measurements': [{'value': '44.02', 'groupId': 'OG000', 'lowerLimit': '35.61', 'upperLimit': '51.75'}, {'value': '37.68', 'groupId': 'OG001', 'lowerLimit': '29.14', 'upperLimit': '45.77'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, to death- no time limit', 'description': 'Overall survival (OS) was defined as the time from date of randomization to the date of death due to any cause. Analyses were performed using all deaths in the FAS population regardless of whether they were observed during the double-blind treatment period, the open-label treatment period, the post-treatment evaluations, or the survival follow-up period.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all randomized patients.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival According to Ki-67 Levels Categorized as: Less Than or Equal to 2%, > 2% to Less Than or Equal to 5% and > 5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus 10 mg/Day', 'description': 'Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).'}], 'classes': [{'title': 'Ki67 <=2% (n: 7, 17)', 'categories': [{'measurements': [{'value': '12.52', 'groupId': 'OG000', 'lowerLimit': '3.42', 'upperLimit': '14.75'}, {'value': '3.68', 'groupId': 'OG001', 'lowerLimit': '2.86', 'upperLimit': '5.52'}]}]}, {'title': '2% <Ki67 <=5% (n: 24, 13)', 'categories': [{'measurements': [{'value': '10.94', 'groupId': 'OG000', 'lowerLimit': '5.55', 'upperLimit': '16.59'}, {'value': '8.48', 'groupId': 'OG001', 'lowerLimit': '3.78', 'upperLimit': '13.83'}]}]}, {'title': 'Ki67 >5% (n: 20, 22)', 'categories': [{'measurements': [{'value': '7.69', 'comment': 'Upper boundary of the 95% (Confidence Interval (CI) was not computable', 'groupId': 'OG000', 'lowerLimit': '5.59', 'upperLimit': 'NA'}, {'value': '3.15', 'groupId': 'OG001', 'lowerLimit': '2.79', 'upperLimit': '5.55'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010', 'description': 'The level of Ki 67 expression for evaluable tumor samples were analyzed towards progression free survival (PFS) as per local investigator assessment. The Ki-67 protein is a cellular marker for proliferation. It is strictly associated with cell proliferation. During interphase, the Ki-67 antigen can be exclusively detected within the cell nucleus, whereas in mitosis most of the protein is relocated to the surface of the chromosomes. Baseline Ki 67 levels were categorized as: less than or equal to 2%, \\> 2% to less than or equal to 5% and \\> 5%.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consisted of all patients who were randomized.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival According to Chromogramin A Tumor Marker (CgA) Baseline Level and According to CgA Early Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus 10 mg/Day', 'description': 'Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).'}], 'classes': [{'title': 'CgA Levels at baseline: CgA <= 2x ULN (n:121, 97)', 'categories': [{'measurements': [{'value': '11.17', 'groupId': 'OG000', 'lowerLimit': '8.54', 'upperLimit': '16.49'}, {'value': '4.90', 'groupId': 'OG001', 'lowerLimit': '2.99', 'upperLimit': '5.55'}]}]}, {'title': 'CgA levels at baseline: CgA > 2x ULN (n:84, 103)', 'categories': [{'measurements': [{'value': '8.54', 'groupId': 'OG000', 'lowerLimit': '7.69', 'upperLimit': '13.80'}, {'value': '4.34', 'groupId': 'OG001', 'lowerLimit': '2.86', 'upperLimit': '5.39'}]}]}, {'title': 'Early CgA response: Response (n: 48, 22)', 'categories': [{'measurements': [{'value': '8.54', 'groupId': 'OG000', 'lowerLimit': '7.56', 'upperLimit': '14.00'}, {'value': '5.70', 'groupId': 'OG001', 'lowerLimit': '3.19', 'upperLimit': '8.54'}]}]}, {'title': 'Early CgA response: Non-Response (n:40, 82)', 'categories': [{'measurements': [{'value': '11.14', 'comment': 'Upper boundary of the 95% Confidence Interval (CI) was not be computable', 'groupId': 'OG000', 'lowerLimit': '6.90', 'upperLimit': 'NA'}, {'value': '3.19', 'groupId': 'OG001', 'lowerLimit': '2.83', 'upperLimit': '5.36'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010', 'description': 'Baseline levels of serum CgA SE were characterized towards progression free survival (PFS) as per local investigator assessment, relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be \'Elevated\' otherwise considered as "Non-elevated". An \'early response\' (applicable to only those patients with elevated levels at baseline) was defined as a decrease of greater than or equal to 30% from baseline to Cycle 2 Day 1 or normalization by Cycle 2 Day 1. CgA is widely expressed in well-differentiated pancreatic NET. CgA is present in the secretory granules of neuroendocrine cells. Pancreatic NET patients often present with elevated circulating levels of CgA in their blood. Baseline levels of these biomarkers are considered as prognostic factors.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consisted of all patients who were randomized.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival According to Neuron Specific Enolase Tumor Marker (NSE) Baseline Level and According to NSE Early Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus 10 mg/Day', 'description': 'Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).'}], 'classes': [{'title': 'NSE Levels at baseline: <= ULN (n: 155, 138)', 'categories': [{'measurements': [{'value': '13.86', 'groupId': 'OG000', 'lowerLimit': '10.81', 'upperLimit': '18.10'}, {'value': '5.36', 'groupId': 'OG001', 'lowerLimit': '3.78', 'upperLimit': '5.55'}]}]}, {'title': 'NSE levels at baseline: > ULN (n: 48, 56)', 'categories': [{'measurements': [{'value': '8.11', 'groupId': 'OG000', 'lowerLimit': '4.24', 'upperLimit': '11.17'}, {'value': '2.83', 'groupId': 'OG001', 'lowerLimit': '2.60', 'upperLimit': '3.06'}]}]}, {'title': 'Early NSE response: Response (n: 24, 16)', 'categories': [{'measurements': [{'value': '8.11', 'groupId': 'OG000', 'lowerLimit': '4.24', 'upperLimit': '11.40'}, {'value': '3.06', 'groupId': 'OG001', 'lowerLimit': '2.23', 'upperLimit': '5.36'}]}]}, {'title': 'Early NSE response: Non-Response (n:16, 27)', 'categories': [{'measurements': [{'value': '3.79', 'groupId': 'OG000', 'lowerLimit': '2.60', 'upperLimit': '13.80'}, {'value': '2.58', 'groupId': 'OG001', 'lowerLimit': '1.84', 'upperLimit': '2.83'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010', 'description': 'Baseline levels of serum NSE were characterized towards PFS as per local investigator assessment, relative to the upper limited of normal (ULN). NSE levels exceeding ULN were considered to be \'Elevated\' otherwise considered as "Non-elevated". An \'early response\' (applicable to only those patients with elevated levels at baseline) was defined as a decrease of greater than or equal to 30% from baseline to Cycle 2 Day 1 or normalization by Cycle 2 Day 1. NSE is widely expressed in well-differentiated pancreatic NET. NSE is usually expressed in the cytoplasm. Pancreatic NET patients often present with elevated circulating levels of NSE in their blood. Baseline levels of these biomarkers are considered as prognostic factors.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consisted of all patients who were randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus 10 mg/Day', 'description': 'Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).'}], 'classes': [{'title': 'Adverse events (AEs)', 'categories': [{'measurements': [{'value': '203', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'on or after the start of double-blind study medication until no later than 28 days after double-blind study medication discontinuation', 'description': 'Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set consists of all patients who received any study drug and had at least one post-baseline safety assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) (Open-label Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus 10 mg/Day', 'description': 'Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).'}], 'classes': [{'title': 'Adverse events (AEs)', 'categories': [{'measurements': [{'value': '221', 'groupId': 'OG000'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'on or after the start of open-label study medication until no later than 28 days after open-label study medication discontinuation', 'description': 'Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The open-label set was used to summarize the safety analyses performed on data collected in the open-label period of the study: the open-label set included only patients who received at least one dose of open-label everolimus 10 mg and had at least one safety assessment during the open-label period of the study.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Pharmacokinetics (PK) Parameter: AUC0-t Last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus 10 mg/Day', 'description': 'Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}, {'id': 'OG001', 'title': 'Everolimus 5 mg/Day', 'description': 'Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}], 'classes': [{'categories': [{'measurements': [{'value': '594', 'spread': '313', 'groupId': 'OG000'}, {'value': '481', 'spread': 'NA', 'comment': 'Summary statistics were only produced if the sample size for the dose group in the respective cycle is 3 or more.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of every cycle (28 days/cycle) throughout the study', 'description': 'The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. This PK parameter is area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t last).', 'unitOfMeasure': 'ng.h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Pharmacokinetics (PK) Parameters: Cmax, Cmin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus 10 mg/Day', 'description': 'Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}, {'id': 'OG001', 'title': 'Everolimus 5 mg/Day', 'description': 'Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}], 'classes': [{'title': 'Cmax', 'categories': [{'measurements': [{'value': '62.4', 'spread': '18.5', 'groupId': 'OG000'}, {'value': '27.4', 'spread': 'NA', 'comment': 'Summary statistics will only be produced if the sample size for the dose group in the respective cycle is 3 or more.', 'groupId': 'OG001'}]}]}, {'title': 'Cmin', 'categories': [{'measurements': [{'value': '9.80', 'spread': '4.95', 'groupId': 'OG000'}, {'value': '12.2', 'spread': 'NA', 'comment': 'Summary statistics will only be produced if the sample size for the dose group in the respective cycle is 3 or more.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of every cycle (28 days/cycle) throughout the study', 'description': 'The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. The PK parameter: maximum (peak) drug concentration (Cmax) and minimum (trough) drug concentration (Cmin).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Pharmacokinetics (PK) Parameter: CL/F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus 10 mg/Day', 'description': 'Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}, {'id': 'OG001', 'title': 'Everolimus 5 mg/Day', 'description': 'Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}], 'classes': [{'categories': [{'measurements': [{'value': '20.2', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '10.7', 'spread': 'NA', 'comment': 'Summary statistics were only produced if the sample size for the dose group in the respective cycle is 3 or more.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of every cycle (28 days/cycle) throughout the study', 'description': 'The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. The PK parameter clearance of distribution expressed as a function of bioavailability (CL/F).', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Pharmacokinetics (PK) Parameter: Tmax -Time to Maximum (Peak) Drug Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus 10 mg/Day', 'description': 'Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}, {'id': 'OG001', 'title': 'Everolimus 5 mg/Day', 'description': 'Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.17', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '24.0'}, {'value': '3.0', 'comment': 'Summary statistics were only produced if the sample size for the dose group in the respective cycle is 3 or more.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 of every cycle (28 days/cycle) throughout the study', 'description': 'The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. Values for tmax where summarized in median (range).', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.'}, {'type': 'SECONDARY', 'title': 'Analysis of Time to Definitive Deterioration of WHO Performance Status Using Kaplan-Meier', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus 10 mg/Day', 'description': 'Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).'}], 'classes': [{'title': 'Month 3', 'categories': [{'measurements': [{'value': '94.4', 'groupId': 'OG000', 'lowerLimit': '90.0', 'upperLimit': '96.8'}, {'value': '91.8', 'groupId': 'OG001', 'lowerLimit': '86.8', 'upperLimit': '95.0'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '90.6', 'groupId': 'OG000', 'lowerLimit': '85.2', 'upperLimit': '94.0'}, {'value': '86.3', 'groupId': 'OG001', 'lowerLimit': '79.3', 'upperLimit': '91.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months, 6 months', 'description': 'Time to definitive worsening is defined as a definitive increase in performance status from a baseline of 0 or 1 to WHO \\>= 2, or from a baseline value of 2 to WHO \\>= 3. If no earlier deterioration, patients were censored at the end of follow-up or at the start of further antineoplastic therapy. Rates of patients with no deterioration at 3 and 6 months were computed using Kaplan-meier method. Grade 0: Able to carry out all activity without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory \\& able to do light work; Grade 2: Ambulatory \\& capable of all self-care but unable to carry out any work. Up \\& about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled \\& cannot carry on any self-care; totally confined to bed or chair.', 'unitOfMeasure': '% of participants with no deterioration', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all patients who were randomized.'}, {'type': 'SECONDARY', 'title': 'Plasma Angiogenesis Marker: Basic Fibroblast Growth Factor (bFGF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus 10 mg/Day', 'description': 'Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).'}], 'classes': [{'title': 'Baseline (n:198, 195)', 'categories': [{'measurements': [{'value': '52.59', 'spread': '101.659', 'groupId': 'OG000'}, {'value': '51.49', 'spread': '78.049', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 1 (n: 185, 184)', 'categories': [{'measurements': [{'value': '38.43', 'spread': '51.809', 'groupId': 'OG000'}, {'value': '58.33', 'spread': '72.938', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 1 (n: 185, 174)', 'categories': [{'measurements': [{'value': '51.97', 'spread': '89.064', 'groupId': 'OG000'}, {'value': '59.08', 'spread': '72.495', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4 Day 1 (n: 171, 159)', 'categories': [{'measurements': [{'value': '51.28', 'spread': '82.139', 'groupId': 'OG000'}, {'value': '54.58', 'spread': '75.350', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1', 'description': 'This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all patients who were randomized.'}, {'type': 'SECONDARY', 'title': 'Plasma Angiogenesis Marker: Placental Growth Factor (PLGF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus 10 mg/Day', 'description': 'Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).'}], 'classes': [{'title': 'Baseline (n:198, 195)', 'categories': [{'measurements': [{'value': '45.82', 'spread': '282.084', 'groupId': 'OG000'}, {'value': '32.92', 'spread': '52.586', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 1 (n: 185, 184)', 'categories': [{'measurements': [{'value': '25.78', 'spread': '33.420', 'groupId': 'OG000'}, {'value': '35.38', 'spread': '57.135', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 1 (n: 185, 174)', 'categories': [{'measurements': [{'value': '26.55', 'spread': '28.839', 'groupId': 'OG000'}, {'value': '33.84', 'spread': '65.361', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4 Day 1 (n: 171, 159)', 'categories': [{'measurements': [{'value': '25.69', 'spread': '18.312', 'groupId': 'OG000'}, {'value': '35.47', 'spread': '67.314', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1', 'description': 'This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all patients who were randomized.'}, {'type': 'SECONDARY', 'title': 'Plasma Angiogenesis Marker: Soluble Vascular Endothelial Growth Factor Receptor 1 (sVEGFR1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus 10 mg/Day', 'description': 'Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).'}], 'classes': [{'title': 'Baseline (n:198, 195)', 'categories': [{'measurements': [{'value': '264.18', 'spread': '272.190', 'groupId': 'OG000'}, {'value': '256.69', 'spread': '187.866', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 1 (n: 185, 184)', 'categories': [{'measurements': [{'value': '307.46', 'spread': '808.316', 'groupId': 'OG000'}, {'value': '299.03', 'spread': '541.933', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 1 (n: 185, 174)', 'categories': [{'measurements': [{'value': '263.81', 'spread': '187.329', 'groupId': 'OG000'}, {'value': '253.37', 'spread': '250.841', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4 Day 1 (n: 171, 159)', 'categories': [{'measurements': [{'value': '258.03', 'spread': '223.980', 'groupId': 'OG000'}, {'value': '242.17', 'spread': '163.561', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1', 'description': 'This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all patients who were randomized.'}, {'type': 'SECONDARY', 'title': 'Plasma Angiogenesis Marker: Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus 10 mg/Day', 'description': 'Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).'}], 'classes': [{'title': 'Baseline (n:197, 193)', 'categories': [{'measurements': [{'value': '30061.30', 'spread': '8607.379', 'groupId': 'OG000'}, {'value': '31299.61', 'spread': '9091.460', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 1 (n: 185, 183)', 'categories': [{'measurements': [{'value': '22691.18', 'spread': '6793.409', 'groupId': 'OG000'}, {'value': '30223.21', 'spread': '8447.992', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 1 (n: 185, 173)', 'categories': [{'measurements': [{'value': '22021.23', 'spread': '6393.414', 'groupId': 'OG000'}, {'value': '29264.67', 'spread': '8408.405', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4 Day 1 (n: 172, 158)', 'categories': [{'measurements': [{'value': '21218.17', 'spread': '6249.977', 'groupId': 'OG000'}, {'value': '28308.58', 'spread': '8477.049', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1', 'description': 'This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all patients who were randomized.'}, {'type': 'SECONDARY', 'title': 'Plasma Angiogenesis Marker: Vascular Endothelial Growth Factor (VEGF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus 10 mg/Day', 'description': 'Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).'}], 'classes': [{'title': 'Baseline (n:198, 195)', 'categories': [{'measurements': [{'value': '265.09', 'spread': '283.123', 'groupId': 'OG000'}, {'value': '326.16', 'spread': '323.891', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 1 (n: 185, 184)', 'categories': [{'measurements': [{'value': '243.03', 'spread': '183.010', 'groupId': 'OG000'}, {'value': '326.78', 'spread': '377.752', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 1 (n: 185, 174)', 'categories': [{'measurements': [{'value': '280.18', 'spread': '268.582', 'groupId': 'OG000'}, {'value': '292.27', 'spread': '286.154', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4 Day 1 (n: 171, 159)', 'categories': [{'measurements': [{'value': '283.51', 'spread': '326.634', 'groupId': 'OG000'}, {'value': '319.60', 'spread': '325.409', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1', 'description': 'This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all patients who were randomized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Everolimus 10 mg/Day', 'description': 'Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).'}], 'periods': [{'title': 'Double-blind Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '207'}, {'groupId': 'FG001', 'numSubjects': '203'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '204'}, {'groupId': 'FG001', 'numSubjects': '203'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '207'}, {'groupId': 'FG001', 'numSubjects': '203'}]}], 'dropWithdraws': [{'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '169'}]}, {'type': 'Final primary analysis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Abnormal test result (s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Open-label Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '172 patients switched over from placebo \\& 53 who were initially randomized to Everolimus arm.', 'groupId': 'FG000', 'numSubjects': '225'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '225'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'New cancer therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Abnormal laboratory value (s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '410', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Everolimus 10 mg/Day', 'description': 'Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '56.2', 'spread': '11.4', 'groupId': 'BG001'}, {'value': '56.6', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '322', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 410}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-04', 'studyFirstSubmitDate': '2007-07-31', 'resultsFirstSubmitDate': '2011-11-11', 'studyFirstSubmitQcDate': '2007-07-31', 'lastUpdatePostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-11-11', 'studyFirstPostDateStruct': {'date': '2007-08-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology', 'timeFrame': 'Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010', 'description': 'Progression of disease is defined as the time from study start to the date of first documented progression of disease or death due to any cause. Progression of disease is defined by RECIST criteria: Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Objective Response Rate ( CR {Complete Response} OR PR {Partial Response})', 'timeFrame': 'Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010', 'description': 'Objective Response defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of the longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks . Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions'}, {'measure': 'Overall Survival', 'timeFrame': 'Baseline, to death- no time limit', 'description': 'Overall survival (OS) was defined as the time from date of randomization to the date of death due to any cause. Analyses were performed using all deaths in the FAS population regardless of whether they were observed during the double-blind treatment period, the open-label treatment period, the post-treatment evaluations, or the survival follow-up period.'}, {'measure': 'Progression Free Survival According to Ki-67 Levels Categorized as: Less Than or Equal to 2%, > 2% to Less Than or Equal to 5% and > 5%', 'timeFrame': 'Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010', 'description': 'The level of Ki 67 expression for evaluable tumor samples were analyzed towards progression free survival (PFS) as per local investigator assessment. The Ki-67 protein is a cellular marker for proliferation. It is strictly associated with cell proliferation. During interphase, the Ki-67 antigen can be exclusively detected within the cell nucleus, whereas in mitosis most of the protein is relocated to the surface of the chromosomes. Baseline Ki 67 levels were categorized as: less than or equal to 2%, \\> 2% to less than or equal to 5% and \\> 5%.'}, {'measure': 'Progression Free Survival According to Chromogramin A Tumor Marker (CgA) Baseline Level and According to CgA Early Response', 'timeFrame': 'Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010', 'description': 'Baseline levels of serum CgA SE were characterized towards progression free survival (PFS) as per local investigator assessment, relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be \'Elevated\' otherwise considered as "Non-elevated". An \'early response\' (applicable to only those patients with elevated levels at baseline) was defined as a decrease of greater than or equal to 30% from baseline to Cycle 2 Day 1 or normalization by Cycle 2 Day 1. CgA is widely expressed in well-differentiated pancreatic NET. CgA is present in the secretory granules of neuroendocrine cells. Pancreatic NET patients often present with elevated circulating levels of CgA in their blood. Baseline levels of these biomarkers are considered as prognostic factors.'}, {'measure': 'Progression Free Survival According to Neuron Specific Enolase Tumor Marker (NSE) Baseline Level and According to NSE Early Response', 'timeFrame': 'Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010', 'description': 'Baseline levels of serum NSE were characterized towards PFS as per local investigator assessment, relative to the upper limited of normal (ULN). NSE levels exceeding ULN were considered to be \'Elevated\' otherwise considered as "Non-elevated". An \'early response\' (applicable to only those patients with elevated levels at baseline) was defined as a decrease of greater than or equal to 30% from baseline to Cycle 2 Day 1 or normalization by Cycle 2 Day 1. NSE is widely expressed in well-differentiated pancreatic NET. NSE is usually expressed in the cytoplasm. Pancreatic NET patients often present with elevated circulating levels of NSE in their blood. Baseline levels of these biomarkers are considered as prognostic factors.'}, {'measure': 'Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs)', 'timeFrame': 'on or after the start of double-blind study medication until no later than 28 days after double-blind study medication discontinuation', 'description': 'Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.'}, {'measure': 'Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) (Open-label Period)', 'timeFrame': 'on or after the start of open-label study medication until no later than 28 days after open-label study medication discontinuation', 'description': 'Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.'}, {'measure': 'Evaluation of Pharmacokinetics (PK) Parameter: AUC0-t Last', 'timeFrame': 'Day 1 of every cycle (28 days/cycle) throughout the study', 'description': 'The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. This PK parameter is area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t last).'}, {'measure': 'Evaluation of Pharmacokinetics (PK) Parameters: Cmax, Cmin', 'timeFrame': 'Day 1 of every cycle (28 days/cycle) throughout the study', 'description': 'The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. The PK parameter: maximum (peak) drug concentration (Cmax) and minimum (trough) drug concentration (Cmin).'}, {'measure': 'Evaluation of Pharmacokinetics (PK) Parameter: CL/F', 'timeFrame': 'Day 1 of every cycle (28 days/cycle) throughout the study', 'description': 'The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. The PK parameter clearance of distribution expressed as a function of bioavailability (CL/F).'}, {'measure': 'Evaluation of Pharmacokinetics (PK) Parameter: Tmax -Time to Maximum (Peak) Drug Concentration', 'timeFrame': 'Day 1 of every cycle (28 days/cycle) throughout the study', 'description': 'The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. Values for tmax where summarized in median (range).'}, {'measure': 'Analysis of Time to Definitive Deterioration of WHO Performance Status Using Kaplan-Meier', 'timeFrame': '3 months, 6 months', 'description': 'Time to definitive worsening is defined as a definitive increase in performance status from a baseline of 0 or 1 to WHO \\>= 2, or from a baseline value of 2 to WHO \\>= 3. If no earlier deterioration, patients were censored at the end of follow-up or at the start of further antineoplastic therapy. Rates of patients with no deterioration at 3 and 6 months were computed using Kaplan-meier method. Grade 0: Able to carry out all activity without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory \\& able to do light work; Grade 2: Ambulatory \\& capable of all self-care but unable to carry out any work. Up \\& about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled \\& cannot carry on any self-care; totally confined to bed or chair.'}, {'measure': 'Plasma Angiogenesis Marker: Basic Fibroblast Growth Factor (bFGF)', 'timeFrame': 'Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1', 'description': 'This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.'}, {'measure': 'Plasma Angiogenesis Marker: Placental Growth Factor (PLGF)', 'timeFrame': 'Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1', 'description': 'This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.'}, {'measure': 'Plasma Angiogenesis Marker: Soluble Vascular Endothelial Growth Factor Receptor 1 (sVEGFR1)', 'timeFrame': 'Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1', 'description': 'This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.'}, {'measure': 'Plasma Angiogenesis Marker: Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2)', 'timeFrame': 'Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1', 'description': 'This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.'}, {'measure': 'Plasma Angiogenesis Marker: Vascular Endothelial Growth Factor (VEGF)', 'timeFrame': 'Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1', 'description': 'This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Phase III', 'Advanced Neuroendocrine Tumor in adults', 'RAD001', 'NET', 'everolimus', 'mTOr', 'islet cell', 'neuroendocrine'], 'conditions': ['Advanced Neuroendocrine Tumors of Pancreatic Origin']}, 'referencesModule': {'references': [{'pmid': '33560090', 'type': 'DERIVED', 'citation': 'Chan DL, Yao JC, Carnaghi C, Buzzoni R, Herbst F, Ridolfi A, Strosberg J, Kulke MH, Pavel M, Singh S. Markers of Systemic Inflammation in Neuroendocrine Tumors: A Pooled Analysis of the RADIANT-3 and RADIANT-4 Studies. Pancreas. 2021 Feb 1;50(2):130-137. doi: 10.1097/MPA.0000000000001745.'}, {'pmid': '28113028', 'type': 'DERIVED', 'citation': 'Yao JC, Voi M, Lincy J, Pavel M. Reply to V. Amoroso et al. J Clin Oncol. 2017 May 1;35(13):1488-1489. doi: 10.1200/JCO.2017.71.3875. Epub 2017 Jan 23. No abstract available.'}, {'pmid': '27621394', 'type': 'DERIVED', 'citation': 'Yao JC, Pavel M, Lombard-Bohas C, Van Cutsem E, Voi M, Brandt U, He W, Chen D, Capdevila J, de Vries EGE, Tomassetti P, Hobday T, Pommier R, Oberg K. Everolimus for the Treatment of Advanced Pancreatic Neuroendocrine Tumors: Overall Survival and Circulating Biomarkers From the Randomized, Phase III RADIANT-3 Study. J Clin Oncol. 2016 Nov 10;34(32):3906-3913. doi: 10.1200/JCO.2016.68.0702. Epub 2016 Sep 30.'}, {'pmid': '25479584', 'type': 'DERIVED', 'citation': 'Lombard-Bohas C, Yao JC, Hobday T, Van Cutsem E, Wolin EM, Panneerselvam A, Stergiopoulos S, Shah MH, Capdevila J, Pommier R. Impact of prior chemotherapy use on the efficacy of everolimus in patients with advanced pancreatic neuroendocrine tumors: a subgroup analysis of the phase III RADIANT-3 trial. Pancreas. 2015 Mar;44(2):181-9. doi: 10.1097/MPA.0000000000000262.'}, {'pmid': '21306238', 'type': 'DERIVED', 'citation': 'Yao JC, Shah MH, Ito T, Bohas CL, Wolin EM, Van Cutsem E, Hobday TJ, Okusaka T, Capdevila J, de Vries EG, Tomassetti P, Pavel ME, Hoosen S, Haas T, Lincy J, Lebwohl D, Oberg K; RAD001 in Advanced Neuroendocrine Tumors, Third Trial (RADIANT-3) Study Group. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med. 2011 Feb 10;364(6):514-23. doi: 10.1056/NEJMoa1009290.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate progression free survival in those participants assigned everolimus 10 mg/day plus Best Supportive Care versus those assigned to placebo plus Best Supportive Care in Advanced Neuroendocrine Tumors of pancreatic origin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Patients must have advanced (unresectable or metastatic) biopsy-proven pancreatic NET\n2. Measurable disease by radiologic assessment\n3. Adequate blood work\n4. Performance Status 0-2 : Ability to be out of bed most of the time\n5. Adult male or female patients ≥ 18 years of age\n6. Women of childbearing potential must have a negative serum pregnancy test\n7. Written informed consent from patients must be obtained in accordance to local guidelines\n\nExclusion criteria:\n\n1. Patients with severe kind of (poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma) cancer are not eligible\n2. Other chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to starting this trial\n3. Hepatic artery procedure called embolization within the last 6 months (1 month if there are other sites of measurable disease), or cryoablation/ radiofrequency ablation of hepatic metastasis within 2 months of enrollment\n4. Prior therapy with the same kind of medication (mTOR inhibitors: sirolimus, temsirolimus, everolimus).\n5. Uncontrolled diabetes mellitus Patients who have any severe and/or uncontrolled medical conditions such as:\n6. Patients receiving chronic treatment with corticosteroids or another immunosuppressive agent\n7. Patients with a known history of HIV seropositivity\n8. No other prior or concurrent cancer at the time enrolling to this trial\n\nOther protocol defined inclusion/ exclusion criteria applied'}, 'identificationModule': {'nctId': 'NCT00510068', 'acronym': 'RADIANT-3', 'briefTitle': 'Efficacy and Safety of Everolimus (RAD001) Compared to Placebo in Patients With Advanced Neuroendocrine Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized Double-blind Phase III Study of RAD001 10 mg/d Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Neuroendocrine Tumor (NET)', 'orgStudyIdInfo': {'id': 'CRAD001C2324'}, 'secondaryIdInfos': [{'id': '2006-006819-75', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Everolimus 10 mg/day', 'description': 'Participants received 10 mg per day of Everolimus plus best supportive care. 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Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).', 'interventionNames': ['Drug: Everolimus Placebo']}], 'interventions': [{'name': 'Everolimus', 'type': 'DRUG', 'otherNames': ['RAD001'], 'description': 'A 10-mg dose of everolimus was given by continuous oral daily dosing of two 5-mg tablets.', 'armGroupLabels': ['Everolimus 10 mg/day']}, {'name': 'Everolimus Placebo', 'type': 'DRUG', 'description': 'a 10-mg dose of matching placebo to Everolimus was given by continuous oral daily dosing of two 5-mg tablets.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36688', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2)', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Cancer Medical Center, Inc.', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center SC-2', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Los Angeles UCLA (3)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143-0128', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco Dept. of UCSF Comp. 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