Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2025-12-31 @ 8:28 AM
Study NCT ID:
NCT00412061
Status:
COMPLETED
Last Update Posted:
2014-11-21
First Post:
2006-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002276', 'term': 'Carcinoid Tumor'}, {'id': 'D008303', 'term': 'Malignant Carcinoid Syndrome'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015282', 'term': 'Octreotide'}, {'id': 'D000068338', 'term': 'Everolimus'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'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': {'description': 'Double blind period, Safety Set consists all patients received at least one dose of study drug and who had at least one valid post-baseline safety assessment. The Open-label Set consists all patients received at least one dose of open-label everolimus and who had at least one valid safety assessment after initiation of open-label treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Everolimus + Octreotide', 'description': 'Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.', 'otherNumAtRisk': 215, 'otherNumAffected': 214, 'seriousNumAtRisk': 215, 'seriousNumAffected': 126}, {'id': 'EG001', 'title': 'Placebo + Octreotide', 'description': 'Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.', 'otherNumAtRisk': 211, 'otherNumAffected': 194, 'seriousNumAtRisk': 211, 'seriousNumAffected': 74}, {'id': 'EG002', 'title': 'Everolimus Open Label', 'description': 'Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.', 'otherNumAtRisk': 170, 'otherNumAffected': 162, 'seriousNumAtRisk': 170, 'seriousNumAffected': 93}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 34}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 68}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 43}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 77}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 77}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 60}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 63}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 103}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 91}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 63}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 62}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 33}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 33}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 24}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 27}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 30}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 32}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 11}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 38}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 27}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 170, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Renal and urinary 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'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Testicular swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Granulomatous pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Laryngeal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tachypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octreotide+ Everolimus', 'description': 'Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.'}, {'id': 'OG001', 'title': 'Octreotide+ Placebo', 'description': 'Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.43', 'groupId': 'OG000', 'lowerLimit': '13.67', 'upperLimit': '21.19'}, {'value': '11.33', 'groupId': 'OG001', 'lowerLimit': '8.44', 'upperLimit': '14.59'}]}]}], '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, 10 January 2007, until cut-off date 02 April 2010', 'description': 'Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary analysis of PFS was based on the independent central adjudicated assessment using Kaplan-Meier method.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consisted of all randomized patients.'}, {'type': 'SECONDARY', 'title': 'Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octreotide+ Everolimus', 'description': 'Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.'}, {'id': 'OG001', 'title': 'Octreotide+ Placebo', 'description': 'Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '5.30'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '4.7'}]}]}], '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, 10 January 2007, until cut-off date 02 April 2010', 'description': 'The best overall response rate is defined as the percentage of patients having achieved confirmed Complete Response + Partial Response. Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octreotide+ Everolimus', 'description': 'Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.'}, {'id': 'OG001', 'title': 'Octreotide+ Placebo', 'description': 'Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.'}], 'classes': [{'title': '5-HIAA <=median (n=93,96)', 'categories': [{'measurements': [{'value': '21.75', 'comment': 'Upper Limit was not applicable or computable as median was just reached.', 'groupId': 'OG000', 'lowerLimit': '13.93', 'upperLimit': 'NA'}, {'value': '13.90', 'groupId': 'OG001', 'lowerLimit': '8.71', 'upperLimit': '22.44'}]}]}, {'title': '5-HIAA > median (n=94,95)', 'categories': [{'measurements': [{'value': '13.83', 'groupId': 'OG000', 'lowerLimit': '10.61', 'upperLimit': '18.63'}, {'value': '8.41', 'groupId': 'OG001', 'lowerLimit': '8.08', 'upperLimit': '11.33'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010', 'description': "5-HIAA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of 5-HIAA in urine were defined as 'High' if they exceeded the median value, and 'Low' if they were lower than or equal to the median.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients. This analysis includes PFS patients with non missing baseline 5-HIAA data.'}, {'type': 'SECONDARY', 'title': 'Overall Survival Using Kaplan-Meier Methodology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octreotide+ Everolimus', 'description': 'Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.'}, {'id': 'OG001', 'title': 'Octreotide+ Placebo Followed by Open Label Arm', 'description': 'Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1. Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.'}], 'classes': [{'title': '12 Months', 'categories': [{'measurements': [{'value': '80.5', 'groupId': 'OG000', 'lowerLimit': '74.5', 'upperLimit': '85.3'}, {'value': '81.8', 'groupId': 'OG001', 'lowerLimit': '75.8', 'upperLimit': '86.4'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '57.0', 'groupId': 'OG000', 'lowerLimit': '49.9', 'upperLimit': '63.4'}, {'value': '63.6', 'groupId': 'OG001', 'lowerLimit': '56.6', 'upperLimit': '69.8'}]}]}, {'title': '36 Months', 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000', 'lowerLimit': '36.0', 'upperLimit': '49.6'}, {'value': '48.5', 'groupId': 'OG001', 'lowerLimit': '41.4', 'upperLimit': '55.3'}]}]}, {'title': '48 Months', 'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG000', 'lowerLimit': '31.2', 'upperLimit': '44.7'}, {'value': '41.6', 'groupId': 'OG001', 'lowerLimit': '34.6', 'upperLimit': '48.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 12, 24, 36, 48', 'description': 'Overall survival was defined as the time from the date of randomization to the date of death from any cause. If a patient was not known to have died, survival was censored at the date of last contact. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Double-Blind Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octreotide+ Everolimus', 'description': 'Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.'}, {'id': 'OG001', 'title': 'Octreotide+ Placebo', 'description': 'Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.'}], 'classes': [{'title': 'Clinically notable AE', 'categories': [{'measurements': [{'value': '208', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3-4 Adverse Events', 'categories': [{'measurements': [{'value': '162', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}]}, {'title': 'On treatment death', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first day of treatment up to 28 days after last day of treatment in double blind', 'description': 'AEs 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. SAEs 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': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Open Label Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus Open Label Arm', 'description': 'Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.'}], 'classes': [{'title': 'Clinically notable AE', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3-4 Adverse Events', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}]}]}, {'title': 'On treatment death', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first day of treatment up to 28 days after last day of treatment in double blind', 'description': 'AEs 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. SAEs 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': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline Chromogranin A (CgA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octreotide+ Everolimus', 'description': 'Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.'}, {'id': 'OG001', 'title': 'Octreotide+ Placebo', 'description': 'Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.'}], 'classes': [{'title': 'CgA<=2x ULN (n=60,78)', 'categories': [{'measurements': [{'value': '31.31', 'comment': 'Upper Limit was not applicable or computable as median was just reached.', 'groupId': 'OG000', 'lowerLimit': '19.32', 'upperLimit': 'NA'}, {'value': '20.07', 'comment': 'Upper Limit was not applicable or computable as median was just reached.', 'groupId': 'OG001', 'lowerLimit': '13.04', 'upperLimit': 'NA'}]}]}, {'title': 'CgA>2x ULN (n=152,130)', 'categories': [{'measurements': [{'value': '13.93', 'groupId': 'OG000', 'lowerLimit': '11.30', 'upperLimit': '17.08'}, {'value': '8.41', 'groupId': 'OG001', 'lowerLimit': '7.72', 'upperLimit': '11.14'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010', 'description': 'Serum CgA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of serum CgA were characterized relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be \'Elevated\'; otherwise considered as "Non-elevated".', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients. This analysis includes PFS patients with non missing baseline CgA data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Octreotide+ Everolimus', 'description': 'Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.'}, {'id': 'FG001', 'title': 'Octreotide+ Placebo Followed by Open Label Arm', 'description': 'Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1. Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.'}], 'periods': [{'title': 'Double Blind Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '216'}, {'groupId': 'FG001', 'numSubjects': '213'}]}, {'type': 'Safety Set', 'achievements': [{'comment': '1 patient did not provide at laest one valid post baseline safety assessment.', 'groupId': 'FG000', 'numSubjects': '215'}, {'comment': '1 pt randomized never took drug Another randomized did not have valid post BL safety assessment', 'groupId': 'FG001', 'numSubjects': '211'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '216'}, {'groupId': 'FG001', 'numSubjects': '213'}]}], 'dropWithdraws': [{'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '154'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Final Primary Analysis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'New Cander Therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Open Label Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '170'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '170'}]}], 'dropWithdraws': [{'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '86'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Administrative Problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'New Cancer Therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Total 429 patients were randomized to double blind phase of treatment. 170 patients moved to the Open Label Phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '429', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Octreotide+ Everolimus', 'description': 'Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.'}, {'id': 'BG001', 'title': 'Octreotide+ Placebo', 'description': 'Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.1', 'spread': '10.72', 'groupId': 'BG000'}, {'value': '59.4', 'spread': '11.13', 'groupId': 'BG001'}, {'value': '59.8', 'spread': '10.92', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 429}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-11', 'studyFirstSubmitDate': '2006-12-13', 'resultsFirstSubmitDate': '2011-10-25', 'studyFirstSubmitQcDate': '2006-12-14', 'lastUpdatePostDateStruct': {'date': '2014-11-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-02-07', 'studyFirstPostDateStruct': {'date': '2006-12-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review', 'timeFrame': 'Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010', 'description': 'Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary analysis of PFS was based on the independent central adjudicated assessment using Kaplan-Meier method.'}], 'secondaryOutcomes': [{'measure': 'Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST)', 'timeFrame': 'Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010', 'description': 'The best overall response rate is defined as the percentage of patients having achieved confirmed Complete Response + Partial Response. Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.'}, {'measure': 'Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level', 'timeFrame': 'If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010', 'description': "5-HIAA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of 5-HIAA in urine were defined as 'High' if they exceeded the median value, and 'Low' if they were lower than or equal to the median."}, {'measure': 'Overall Survival Using Kaplan-Meier Methodology', 'timeFrame': 'Months 12, 24, 36, 48', 'description': 'Overall survival was defined as the time from the date of randomization to the date of death from any cause. If a patient was not known to have died, survival was censored at the date of last contact. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group.'}, {'measure': 'Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Double-Blind Phase)', 'timeFrame': 'From first day of treatment up to 28 days after last day of treatment in double blind', 'description': 'AEs 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. SAEs 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 Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Open Label Phase)', 'timeFrame': 'From first day of treatment up to 28 days after last day of treatment in double blind', 'description': 'AEs 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. SAEs 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': 'Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline Chromogranin A (CgA)', 'timeFrame': 'If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010', 'description': 'Serum CgA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of serum CgA were characterized relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be \'Elevated\'; otherwise considered as "Non-elevated".'}]}, 'conditionsModule': {'keywords': ['Cancer', 'Carcinoid', 'Tumor', 'Neuroendocrine', 'Carcinoma', 'Everolimus', 'Octreotide'], 'conditions': ['Carcinoid Tumor', 'Malignant Carcinoid Syndrome']}, 'referencesModule': {'references': [{'pmid': '28444114', 'type': 'DERIVED', 'citation': 'Pavel ME, Baudin E, Oberg KE, Hainsworth JD, Voi M, Rouyrre N, Peeters M, Gross DJ, Yao JC. Efficacy of everolimus plus octreotide LAR in patients with advanced neuroendocrine tumor and carcinoid syndrome: final overall survival from the randomized, placebo-controlled phase 3 RADIANT-2 study. Ann Oncol. 2017 Jul 1;28(7):1569-1575. doi: 10.1093/annonc/mdx193.'}, {'pmid': '23187897', 'type': 'DERIVED', 'citation': 'Fazio N, Granberg D, Grossman A, Saletan S, Klimovsky J, Panneerselvam A, Wolin EM. Everolimus plus octreotide long-acting repeatable in patients with advanced lung neuroendocrine tumors: analysis of the phase 3, randomized, placebo-controlled RADIANT-2 study. Chest. 2013 Apr;143(4):955-962. doi: 10.1378/chest.12-1108.'}, {'pmid': '22119496', 'type': 'DERIVED', 'citation': 'Pavel ME, Hainsworth JD, Baudin E, Peeters M, Horsch D, Winkler RE, Klimovsky J, Lebwohl D, Jehl V, Wolin EM, Oberg K, Van Cutsem E, Yao JC; RADIANT-2 Study Group. Everolimus plus octreotide long-acting repeatable for the treatment of advanced neuroendocrine tumours associated with carcinoid syndrome (RADIANT-2): a randomised, placebo-controlled, phase 3 study. Lancet. 2011 Dec 10;378(9808):2005-2012. doi: 10.1016/S0140-6736(11)61742-X. Epub 2011 Nov 25.'}], 'seeAlsoLinks': [{'url': 'http://www.novartisclinicaltrials.com', 'label': 'Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate whether everolimus 10 mg / day added to treatment with depot octreotide prolongs progression free survival compared to treatment with octreotide alone in patients with advanced carcinoid tumor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Advanced (unresectable or metastatic) carcinoid tumor\n* Confirmed low-grade or intermediate-grade neuroendocrine carcinoma\n* Documented progression of disease within 12 months prior to randomization.\n* Measurable disease determined by triphasic computer tomography (CT) scan or magnetic resonance imaging (MRI).\n\nExclusion criteria:\n\n* Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoma, or small cell carcinoma.\n* Hepatic artery embolization within the last 6 months or cryoablation of hepatic metastasis within 2 months of enrollment.\n* Previous treatment with mammalian target of rapamycin (mTOR) inhibitors (sirolimus, temsirolimus, everolimus)\n* Intolerance or hypersensitivity to octreotide, everolimus, or other rapamycins.\n* Severe or uncontrolled medical conditions\n* Chronic treatment with corticosteroids or other immunosuppressive agent.\n* Other primary cancer within 3 years.\n\nOther protocol-defined inclusion/exclusion criteria applied'}, 'identificationModule': {'nctId': 'NCT00412061', 'acronym': 'RADIANT-2', 'briefTitle': 'Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind Placebo-controlled, Multicenter Phase III Study in Patients With Advanced Carcinoid Tumor Receiving Octreotide Depot and Everolimus 10 mg/Day or Octreotide Depot and Placebo', 'orgStudyIdInfo': {'id': 'CRAD001C2325'}, 'secondaryIdInfos': [{'id': '2006-004507-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Octreotide+ Everolimus', 'description': 'Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.', 'interventionNames': ['Drug: Octreotide', 'Drug: Everolimus']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Octreotide+ Placebo', 'description': 'Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.', 'interventionNames': ['Drug: Octreotide', 'Drug: Placebo']}], 'interventions': [{'name': 'Octreotide', 'type': 'DRUG', 'otherNames': ['Sandostatin LAR® Depot'], 'description': 'Octreotide 30 mg intramuscularly (i.m.) every 28 days.', 'armGroupLabels': ['Octreotide+ Everolimus', 'Octreotide+ Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'A 10-mg oral daily dosing regimen (two 5-mg tablets) of matching placebo.', 'armGroupLabels': ['Octreotide+ Placebo']}, {'name': 'Everolimus', 'type': 'DRUG', 'otherNames': ['RAD001'], 'description': 'A 10-mg oral daily dosing regimen (two 5-mg tablets) of everolimus.', 'armGroupLabels': ['Octreotide+ Everolimus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona / Arizona Cancer Center Deptof Uof A/Arizona Cancer(2)', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Highlands Oncology Group The Center for Chest Care', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Hematology Oncology Services of Arkansas', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'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 New SC Address', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Dept. of Univ. of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers Dept of Rocky Mountain (2)', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06360', 'city': 'Norwich', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Eastern Connecticut Hematology & Oncology Associates Dept. of ECHO', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}, {'zip': '06489', 'city': 'Southington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Cancer Centers of Connecticut Southington Location', 'geoPoint': {'lat': 41.59649, 'lon': -72.8776}}, {'zip': '06902', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hematology Oncology PC Dept.of Hematology Oncology(2)', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Ocala Oncology Center Dept. of Ocala Oncology Center', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '60714', 'city': 'Niles', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cancer Care and Hematology Specialists of Chicagoland Niles', 'geoPoint': {'lat': 42.01892, 'lon': -87.80284}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Dept.of IndianaUniv.CancerCtr', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46227', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Central Indiana Cancer Centers CICC - 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