Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
Study NCT ID:
NCT01374906
Status:
COMPLETED
Last Update Posted:
2018-05-22
First Post:
2011-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047748', 'term': 'Pituitary ACTH Hypersecretion'}, {'id': 'D006964', 'term': 'Hyperpituitarism'}], 'ancestors': [{'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C517782', 'term': 'pasireotide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'novartis.email@novartis.com', '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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'All analyses in this study were descriptive in nature. No comparisons were made between the two arms, and no p-values are reported. For the primary and key-secondary, success was based on estimating the response rate (and 95% CI) in each arm.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 5 years.', 'eventGroups': [{'id': 'EG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.', 'otherNumAtRisk': 74, 'otherNumAffected': 73, 'seriousNumAtRisk': 74, 'seriousNumAffected': 22}, {'id': 'EG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.', 'otherNumAtRisk': 76, 'otherNumAffected': 76, 'seriousNumAtRisk': 76, 'seriousNumAffected': 19}, {'id': 'EG002', 'title': 'All Patients', 'description': 'All Patients from both the 10 mg and 30 mg groups.', 'otherNumAtRisk': 150, 'otherNumAffected': 149, 'seriousNumAtRisk': 150, 'seriousNumAffected': 41}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 10}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 5}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 61}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 48}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 6}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Gallbladder cholesterolosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 6}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 6}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 7}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Blood cortisol decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Glycosylated haemoglobin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 35}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 71}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 28}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pruritus', 'stats': 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{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 24}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Oedematous pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Stress fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Blood cortisol decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Blood cortisol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Endometrial hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pulmonary artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Participants That Attained a mUFC ≤ 1.0 x ULN at Month 7 Regardless of Dose Titration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.9', 'groupId': 'OG000', 'lowerLimit': '30.51', 'upperLimit': '53.94'}, {'value': '40.8', 'groupId': 'OG001', 'lowerLimit': '29.65', 'upperLimit': '52.67'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 7', 'description': 'Percentage of participants that attained a mean urinary free cortisol (mUFC) \\<= 1.0 x upper limit of normal (ULN) at Month 7 regardless of dose up-titration at Month 4. Patients who discontinued before month 4 evaluations classed as non-responders. For patients missing month 7 mUFC assessments, the last available mUFC assessment at or after month 4 was carried forward as the month 7 mUFC assessment value.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants That Attained a mUFC ≤ 1.0 x ULN at Month 7 and Had Not Had a Dose Increase at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.4', 'groupId': 'OG000', 'lowerLimit': '18.50', 'upperLimit': '40.05'}, {'value': '31.6', 'groupId': 'OG001', 'lowerLimit': '21.39', 'upperLimit': '43.25'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 7', 'description': 'Percentage of participants that attain a mUFC ≤ 1.0×ULN at Month 7 and had not had a dose increase at Month 4. Patients who had a dose increase prior to Month 7 were counted as non-responders in this analysis.\n\nPatients who discontinued before month 4 evaluations classed as non-responders. For patients missing month 7 mUFC assessments, the last available mUFC assessment at or after month 4 was carried forward as the month 7 mUFC assessment value.\n\nA responder was defined as a patient who attains mUFC ≤1.0 X ULN and had not had a dose increase at Month 4.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Actual Change in Mean Urinary Free Cortisol (mUFC) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'title': 'M7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-192.4', 'spread': '271.59', 'groupId': 'OG000'}, {'value': '-234.3', 'spread': '362.86', 'groupId': 'OG001'}]}]}, {'title': 'M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-195.1', 'spread': '282.46', 'groupId': 'OG000'}, {'value': '-247.6', 'spread': '387.05', 'groupId': 'OG001'}]}]}, {'title': 'M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-236.2', 'spread': '292.91', 'groupId': 'OG000'}, {'value': '-265.2', 'spread': '313.47', 'groupId': 'OG001'}]}]}, {'title': 'M36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-398.4', 'spread': '136.09', 'groupId': 'OG000'}, {'value': '-164.6', 'spread': '66.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, Month 7 (M7), Month 12 (M12), Month 24 (M24) , Month 36 (M36)', 'description': 'Actual change in mUFC (nmol/24h) from baseline by randomized groups.', 'unitOfMeasure': 'nmol/24h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Mean Urinary Free Cortisol (mUFC) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'title': 'M7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-29.3', 'spread': '102.76', 'groupId': 'OG000'}, {'value': '-33.2', 'spread': '61.37', 'groupId': 'OG001'}]}]}, {'title': 'M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-30.3', 'spread': '79.73', 'groupId': 'OG000'}, {'value': '-31.1', 'spread': '78.41', 'groupId': 'OG001'}]}]}, {'title': 'M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-50.9', 'spread': '76.48', 'groupId': 'OG000'}, {'value': '-51.2', 'spread': '35.41', 'groupId': 'OG001'}]}]}, {'title': 'M36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-71.6', 'spread': '20.44', 'groupId': 'OG000'}, {'value': '-48.8', 'spread': '11.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'M7, M12, M24, M36', 'description': 'Percentage change in mUFC (nmol/24h) from baseline by randomized groups.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Attain mUFC ≤ 1.0 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'title': 'M7 - Controlled responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.2', 'groupId': 'OG000', 'lowerLimit': '28.04', 'upperLimit': '51.23'}, {'value': '40.8', 'groupId': 'OG001', 'lowerLimit': '29.65', 'upperLimit': '52.67'}]}]}, {'title': 'M12 - Controlled responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.1', 'groupId': 'OG000', 'lowerLimit': '24.39', 'upperLimit': '47.11'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '15.77', 'upperLimit': '36.26'}]}]}, {'title': 'M24 - Controlled responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.7', 'groupId': 'OG000', 'lowerLimit': '27.57', 'upperLimit': '52.80'}, {'value': '21.3', 'groupId': 'OG001', 'lowerLimit': '11.86', 'upperLimit': '33.68'}]}]}, {'title': 'M36 - Controlled responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000', 'lowerLimit': '11.53', 'upperLimit': '35.96'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '0.49', 'upperLimit': '13.71'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'M7, M12, M24, M36', 'description': 'Controlled responder: mUFC ≤ 1.0×ULN by randomized groups.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Attain mUFC ≤1.0 x ULN or Have at Least 50 % Reduction From Baseline in mUFC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'title': 'M7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.6', 'groupId': 'OG000', 'lowerLimit': '33.02', 'upperLimit': '56.61'}, {'value': '53.9', 'groupId': 'OG001', 'lowerLimit': '42.13', 'upperLimit': '65.45'}]}]}, {'title': 'M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.9', 'groupId': 'OG000', 'lowerLimit': '34.29', 'upperLimit': '57.93'}, {'value': '42.1', 'groupId': 'OG001', 'lowerLimit': '30.86', 'upperLimit': '53.98'}]}]}, {'title': 'M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.0', 'groupId': 'OG000', 'lowerLimit': '33.39', 'upperLimit': '59.06'}, {'value': '27.9', 'groupId': 'OG001', 'lowerLimit': '17.15', 'upperLimit': '40.83'}]}]}, {'title': 'M36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000', 'lowerLimit': '16.23', 'upperLimit': '42.49'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '1.25', 'upperLimit': '16.55'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'M7, M12, M24, M36', 'description': 'Controlled responder: mUFC ≤ 1.0×ULN. Partially controlled responder: at least 50% reduction in mUFC from Baseline, and mUFC \\>1.0×ULN.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Are Controlled Responders (mUFC ≤ 1.0 xULN) on at Least 4 of the 7 mUFC Assessments by Month 7 & on at Least 7 of the 12 mUFC Assessments by Month 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'title': 'Month 7', 'categories': [{'measurements': [{'value': '25.7', 'groupId': 'OG000', 'lowerLimit': '16.22', 'upperLimit': '37.16'}, {'value': '31.6', 'groupId': 'OG001', 'lowerLimit': '21.39', 'upperLimit': '43.25'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '25.7', 'groupId': 'OG000', 'lowerLimit': '16.22', 'upperLimit': '37.16'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '15.77', 'upperLimit': '36.26'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 7, Month 12', 'description': 'Percentage of patients with mUFC ≤ 1.0 x ULN at a minimum of 4 months up to and including Month 7, and at a minimum of 7 months up to and including Month 12 by randomized groups.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Uncontrolled Response at Month 7 & Month 12 Within the Subset of Patients Who Had Uncontrolled Response at a) Months 1 and 2; b) Months 1, 2, and 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'title': 'Uncontrolled Resp @ M7: subset: M1 & 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.6', 'groupId': 'OG000'}, {'value': '60.6', 'groupId': 'OG001'}]}]}, {'title': 'Uncontrolled Resp @ M7: subset: M1,2 & 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.3', 'groupId': 'OG000'}, {'value': '65.5', 'groupId': 'OG001'}]}]}, {'title': 'Uncontrolled Resp @ M12: subset: M1 & 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.7', 'groupId': 'OG000'}, {'value': '69.7', 'groupId': 'OG001'}]}]}, {'title': 'Uncontrolled Resp @ M12: subset: M1, 2 & 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.2', 'groupId': 'OG000'}, {'value': '72.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 7, Month12', 'description': 'Percentage of patients with mUFC \\> 1.0 xULN at Month 7 and Month 12 within the subset of patients who were uncontrolled at a) Months 1 \\& 2, b) Months 1, 2, \\& 3 by randomized groups.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Attaining a mUFC ≤ 1.0 x ULN or at Least a 50% Reduction in mUFC From Baseline at Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'title': 'Month 7', 'categories': [{'measurements': [{'value': '86.2', 'groupId': 'OG000', 'lowerLimit': '76.1', 'upperLimit': '93.5'}, {'value': '83.4', 'groupId': 'OG001', 'lowerLimit': '72.6', 'upperLimit': '91.8'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '90.1', 'groupId': 'OG000', 'lowerLimit': '80.7', 'upperLimit': '96.2'}, {'value': '94.5', 'groupId': 'OG001', 'lowerLimit': '81.0', 'upperLimit': '99.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Momth 7, Month 12', 'description': 'Time to first achievement of attaining a mUFC ≤ 1.0 x ULN or at least a 50% reduction in mUFC from baseline by randomized groups.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Attaining a Duration of Controlled or Partially Controlled Response at Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '78.0', 'groupId': 'OG000', 'lowerLimit': '66.5', 'upperLimit': '87.7'}, {'value': '72.9', 'groupId': 'OG001', 'lowerLimit': '61.2', 'upperLimit': '83.4'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '84.0', 'groupId': 'OG000', 'lowerLimit': '73.1', 'upperLimit': '92.2'}, {'value': '82.8', 'groupId': 'OG001', 'lowerLimit': '71.5', 'upperLimit': '91.5'}]}]}, {'title': 'Month 18', 'categories': [{'measurements': [{'value': '84.0', 'groupId': 'OG000', 'lowerLimit': '73.1', 'upperLimit': '92.2'}, {'value': '87.1', 'groupId': 'OG001', 'lowerLimit': '74.6', 'upperLimit': '95.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, 12, 18', 'description': "Duration of controlled or partially controlled response is defined as the period starting from the date of patient's first normalization (mUFC≤ 1.0 x ULN) or at least 50% reduction from baseline up to the date when the patient's mUFC \\>1.0 x ULN and the reduction from baseline falls to less than 50% for the first time.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline on Plasma Adrenocorticotropic Hormone (ACTH) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'title': 'M7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '57.14', 'groupId': 'OG000'}, {'value': '-13.5', 'spread': '46.75', 'groupId': 'OG001'}]}]}, {'title': 'M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.2', 'spread': '57.57', 'groupId': 'OG000'}, {'value': '-14.5', 'spread': '38.72', 'groupId': 'OG001'}]}]}, {'title': 'M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.1', 'spread': '43.51', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '68.69', 'groupId': 'OG001'}]}]}, {'title': 'M36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.4', 'spread': '36.90', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '48.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 7, 12, 24 & 36', 'description': 'Percentage change in ACTH (pmol/L) from Baseline by randomized groups.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline on Serum Cortisol Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'title': 'M7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.2', 'spread': '37.83', 'groupId': 'OG000'}, {'value': '-5.1', 'spread': '40.20', 'groupId': 'OG001'}]}]}, {'title': 'M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.1', 'spread': '29.69', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '35.91', 'groupId': 'OG001'}]}]}, {'title': 'M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.6', 'spread': '30.67', 'groupId': 'OG000'}, {'value': '-7.4', 'spread': '38.37', 'groupId': 'OG001'}]}]}, {'title': 'M36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '55.67', 'groupId': 'OG000'}, {'value': '-23.2', 'spread': '31.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 7, 12, 24 & 36', 'description': 'Percentage change in serum cortisol (nmol/L) from Baseline by randomized groups.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Actual Change From Baseline in Clinical Signs Over Time: Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'title': 'Supine systolic blood pressure (SBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.8', 'spread': '15.64', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '14.51', 'groupId': 'OG001'}]}]}, {'title': 'Supine diastolic blood (DBP) pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.8', 'spread': '12.06', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '12.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 7', 'description': 'Change in blood pressure measurements from Baseline', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Actual Change From Baseline in Clinical Signs Over Time: Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '2.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 7', 'description': 'Change in BMI measurements from Baseline', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Actual Change From Baseline in Clinical Signs Over Time: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '4.16', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '5.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 7', 'description': 'Change in weight measurements from Baseline', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Actual Change From Baseline in Clinical Signs Over Time: Body Composition: Region', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '3.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 7', 'description': 'Change in body composition: region measurements from Baseline', 'unitOfMeasure': 'percentage fat', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Actual Change From Baseline in Clinical Signs Over Time: Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '8.47', 'groupId': 'OG000'}, {'value': '-7.1', 'spread': '11.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 7', 'description': 'Change in waist circumference measurements from Baseline', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Actual Change From Baseline in Clinical Signs Over Time: Cholesterol & Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'title': 'Total cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.00', 'groupId': 'OG001'}]}]}, {'title': 'HDL cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 7', 'description': 'Change in parameter measurements: cholesterol \\& triglycerides from Baseline', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Clinical Signs Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'title': 'SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.3', 'spread': '11.46', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '10.18', 'groupId': 'OG001'}]}]}, {'title': 'DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.7', 'spread': '14.19', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '13.78', 'groupId': 'OG001'}]}]}, {'title': 'BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '5.26', 'groupId': 'OG000'}, {'value': '-6.1', 'spread': '6.94', 'groupId': 'OG001'}]}]}, {'title': 'Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '5.26', 'groupId': 'OG000'}, {'value': '-6.1', 'spread': '6.91', 'groupId': 'OG001'}]}]}, {'title': 'Waist circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '8.60', 'groupId': 'OG000'}, {'value': '-6.6', 'spread': '10.06', 'groupId': 'OG001'}]}]}, {'title': 'HDL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.7', 'spread': '15.18', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '20.91', 'groupId': 'OG001'}]}]}, {'title': 'Total cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.2', 'spread': '16.86', 'groupId': 'OG000'}, {'value': '-6.6', 'spread': '16.40', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '39.54', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '39.61', 'groupId': 'OG001'}]}]}, {'title': 'Body composition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '6.68', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '10.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 7', 'description': 'Percentage change in parameter measurements: blood pressure, body mass index, waist circumference, fasting serum lipid profile, weight, bone density and body composition (examined by DXA scan) from Baseline', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Having a Favorable Shift From Baseline in Clinical Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'title': 'Facial rubor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.7', 'groupId': 'OG000'}, {'value': '53.6', 'groupId': 'OG001'}]}]}, {'title': 'Hirsutism (females only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000'}, {'value': '32.6', 'groupId': 'OG001'}]}]}, {'title': 'Striae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000'}, {'value': '23.6', 'groupId': 'OG001'}]}]}, {'title': 'Bruising', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}]}]}, {'title': 'Supraclavicular fat pad', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.4', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}]}]}, {'title': 'Dorsal fat pad', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}]}]}, {'title': 'Muscle strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}, {'value': '4.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 7', 'description': 'This includes patients with improvements in symptoms from baseline. Clinical signs over time include: facial rubor, fat pads, hirsutism, striae, (via photographs by a second local physician who was blinded to the treatment dose and time point of the photograph) and muscle strength.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants That Attained a Mean Urinary Free Cortisol (mUFC) <= 1.0 x Upper Limit of Normal (ULN) at Month 7 Regardless of Dose Up-titration at Month 4.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'title': 'stratum:1.5 x ULN to < 2.0 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.0', 'groupId': 'OG000', 'lowerLimit': '31.31', 'upperLimit': '72.20'}, {'value': '52.0', 'groupId': 'OG001', 'lowerLimit': '31.31', 'upperLimit': '72.20'}]}]}, {'title': 'stratum:2.0 x ULN to <= 5.0 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.7', 'groupId': 'OG000', 'lowerLimit': '23.42', 'upperLimit': '51.71'}, {'value': '35.3', 'groupId': 'OG001', 'lowerLimit': '22.43', 'upperLimit': '49.93'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 7', 'description': 'All of the participants who discontinued prior to month 4 evaluations were classed as non-responders. For participants missing month 7 mUFC assessments, the last available mUFC assessment at or after month 4 was carried forward as the month 7 mUFC assessment value.\n\nAnalysis split by screening strata of mUFC Stratum 1: mUFC 1.5x to \\< 2.0 x ULN Stratum 2: mUFC 2.0x to \\<= 5.0 x ULN', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients That Attain a Reduction of at Least 50% in mUFC From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'title': 'M7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.1', 'groupId': 'OG000', 'lowerLimit': '24.39', 'upperLimit': '47.11'}, {'value': '43.4', 'groupId': 'OG001', 'lowerLimit': '32.08', 'upperLimit': '55.29'}]}]}, {'title': 'M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.1', 'groupId': 'OG000', 'lowerLimit': '24.39', 'upperLimit': '47.11'}, {'value': '38.2', 'groupId': 'OG001', 'lowerLimit': '27.25', 'upperLimit': '50.02'}]}]}, {'title': 'M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '62.62', 'upperLimit': '95.26'}, {'value': '57.1', 'groupId': 'OG001', 'lowerLimit': '28.86', 'upperLimit': '82.34'}]}]}, {'title': 'M36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '63.06', 'upperLimit': '100.00'}, {'value': '33.33', 'groupId': 'OG001', 'lowerLimit': '0.84', 'upperLimit': '90.57'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 7, 12, 24 & 36', 'description': 'All of the participants who discontinued prior to month 4 evaluations were classed as non-responders. For participants missing month 7 mUFC assessments, the last available mUFC assessment at or after month 4 was carried forward as the month 7 mUFC assessment value.\n\nAnalysis split by screening strata of mUFC\n\nStratum 1:', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Attaining a Time to First Achievement of at Least a 50% Reduction in mUFC From Baseline at Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'title': 'M7', 'categories': [{'measurements': [{'value': '80.5', 'groupId': 'OG000', 'lowerLimit': '69.7', 'upperLimit': '89.3'}, {'value': '73.4', 'groupId': 'OG001', 'lowerLimit': '62.4', 'upperLimit': '83.4'}]}]}, {'title': 'M12', 'categories': [{'measurements': [{'value': '84.4', 'groupId': 'OG000', 'lowerLimit': '74.0', 'upperLimit': '92.3'}, {'value': '80.7', 'groupId': 'OG001', 'lowerLimit': '69.4', 'upperLimit': '89.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'every month in the core phase and every 3 months in the extension phase) up to and including the cut-off date for the Month 12 CSR (10-Nov-2015)', 'description': 'Time to first achievement of a 5by randomized groups.0% reduction in mUFC from baseline', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With a Duration of at Least 50% Reduction in mUFC From Baseline at Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'title': 'M6', 'categories': [{'measurements': [{'value': '78.4', 'groupId': 'OG000', 'lowerLimit': '66.6', 'upperLimit': '88.3'}, {'value': '77.8', 'groupId': 'OG001', 'lowerLimit': '66.0', 'upperLimit': '87.7'}]}]}, {'title': 'M12', 'categories': [{'measurements': [{'value': '84.9', 'groupId': 'OG000', 'lowerLimit': '73.7', 'upperLimit': '93.1'}, {'value': '83.7', 'groupId': 'OG001', 'lowerLimit': '72.6', 'upperLimit': '92.1'}]}]}, {'title': 'M18', 'categories': [{'measurements': [{'value': '84.9', 'groupId': 'OG000', 'lowerLimit': '73.7', 'upperLimit': '93.1'}, {'value': '83.7', 'groupId': 'OG001', 'lowerLimit': '72.6', 'upperLimit': '92.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 6, 12 & 18', 'description': "Duration of 50% reduction from baseline is defined as the period starting from the date of patient's first 50% reduction from baseline", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameter: Ctrough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}, {'id': 'OG002', 'title': '5 mg Pasireotide LAR Dose', 'description': 'These patients were dosed with 5 mg of Pasireotide LAR to assess Pharmacokinetics (PK).'}, {'id': 'OG003', 'title': '40 mg Pasireotide LAR Dose', 'description': 'These patients were dosed with 40 mg of Pasireotide LAR to assess Pharmacokinetics (PK).'}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.03', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '7.63', 'spread': '4.58', 'groupId': 'OG001'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.35', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '7.82', 'spread': '4.22', 'groupId': 'OG001'}, {'value': '0.83', 'spread': 'NA', 'comment': 'N/A = not enough patients on this day to derive data', 'groupId': 'OG002'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.39', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '8.56', 'spread': '4.26', 'groupId': 'OG001'}, {'value': '1.03', 'spread': '0.63', 'groupId': 'OG002'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.40', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '8.31', 'spread': '3.87', 'groupId': 'OG001'}, {'value': '1.29', 'spread': '0.24', 'groupId': 'OG002'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.47', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '7.88', 'spread': '4.00', 'groupId': 'OG001'}, {'value': '1.04', 'spread': '0.68', 'groupId': 'OG002'}, {'value': '10.7', 'spread': '4.91', 'groupId': 'OG003'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.47', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '8.46', 'spread': '3.51', 'groupId': 'OG001'}, {'value': '2.01', 'spread': '0.22', 'groupId': 'OG002'}, {'value': '12.0', 'spread': '5.08', 'groupId': 'OG003'}]}]}, {'title': 'Day 197', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.88', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '9.13', 'spread': '4.25', 'groupId': 'OG001'}, {'value': '0.72', 'spread': '0.39', 'groupId': 'OG002'}, {'value': '11.9', 'spread': '5.87', 'groupId': 'OG003'}]}]}, {'title': 'Day 225', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.68', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '8.57', 'spread': '4.70', 'groupId': 'OG001'}, {'value': '1.19', 'spread': '0.43', 'groupId': 'OG002'}, {'value': '11.3', 'spread': '5.18', 'groupId': 'OG003'}]}]}, {'title': 'Day 253', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.87', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '9.00', 'spread': '4.93', 'groupId': 'OG001'}, {'value': '1.77', 'spread': '0.88', 'groupId': 'OG002'}, {'value': '12.1', 'spread': '5.21', 'groupId': 'OG003'}]}]}, {'title': 'Day 281', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.36', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '8.18', 'spread': '4.23', 'groupId': 'OG001'}, {'value': '1.24', 'spread': '0.52', 'groupId': 'OG002'}, {'value': '11.4', 'spread': '5.85', 'groupId': 'OG003'}]}]}, {'title': 'Day 309', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.50', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '9.34', 'spread': '5.61', 'groupId': 'OG001'}, {'value': '0.66', 'spread': 'NA', 'comment': 'N/A = not enough patients on this day to derive data', 'groupId': 'OG002'}, {'value': '12.0', 'spread': '4.58', 'groupId': 'OG003'}]}]}, {'title': 'Day 337', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.07', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '8.90', 'spread': '4.37', 'groupId': 'OG001'}, {'value': '1.91', 'spread': '1.79', 'groupId': 'OG002'}, {'value': '12.6', 'spread': '6.21', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337', 'description': 'Pasireotide trough levels (Ctrough) was 1 of the parameters used for PK assessments. Ctrough is the pre-dose PK concentration with an elapsed time from previous injection of 28+/-2 days. All patients randomized to the study had at least 1 PK observation \\& were therefore included in the pharmacokinetic analysis set. PK observations with missing concentrations, missing dose, missing elapsed time or an elapsed time from previous injection outside of 28 ±2 days window were excluded. Given that SOM230 LAR was administered once a month, Ctrough was collected every 28 days and thus this provides a summary of Ctrough values provided by incident dose (last dose administered prior to PK sample collection), not by randomized dose, hence each column is equivalent to an incident dose \\& not an arm/group. Patients randomized to either 10mg or 30mg could be titrated down to 5mg due to safety, or titrated up to 40mg, hence the 4 incident doses/columns that were allowed per protocol during this study.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PAS): The PAS consists of all randomized patients who have received at least one dose of study drug and had at least one post dosing PK assessment.\n\nPatients were analyzed according to incident dose (defined as the last dose prior to the PK sample).'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameter: Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}, {'id': 'OG002', 'title': '5 mg Pasireptide LAR Dose', 'description': 'These patients were dosed with 5 mg of Pasireotide LAR to assess Pharmacokinetics (PK).'}, {'id': 'OG003', 'title': '40 mg Pasireotide LAR Dose', 'description': 'These patients were dosed with 40 mg of Pasireotide LAR to assess Pharmacokinetics (PK).'}], 'classes': [{'title': 'Day 22 (M 0.75)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '3.99', 'groupId': 'OG001'}]}]}, {'title': 'Day 106 (M 3.75)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '3.72', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '0.42', 'groupId': 'OG002'}]}]}, {'title': 'Day 190 (M6.75)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '3.91', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '0.78', 'groupId': 'OG002'}, {'value': '12.1', 'spread': '5.21', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 22, 106, 190', 'description': 'Pasireotide peak levels (Cmax) was one of the parameters used for PK assessments. Cmax is the post-dose PK concentration with an elapsed time from the previous injection of 21+/-2 days. All patients randomized to the study had at least one PK observation and were therefore included in the pharmacokinetic analysis set (PAS). Cmax PK observations ("Day 20" and "Day 104") with an elapsed time from the previous injection outside of 21+/-2 days window were excluded. Given that SOM230 LAR was administered once a month, the Cmax were collected every 28 days in this study, thus this provides a summary of Cmax values provided by incident dose (last dose administered prior to PK sample collection), not by randomized dose, hence each column is equivalent to an incident dose and not an arm/group. Patients randomized to either the 10mg or 30mg could be titrated down to 5mg due to safety, or titrated up to 40mg, hence the 4 incident doses/columns that were allowed per protocol during this study.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PAS): The PAS consists of all randomized patients who have received at least one dose of study drug and had at least one post dosing PK assessment.\n\nPatients were analyzed according to incident dose (defined as the last dose prior to the PK sample).'}, {'type': 'SECONDARY', 'title': "Actual Change in Standardized Score of Cushing's Disease HRQoL (CushingQOL) Score From Baseline", 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'title': 'M7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '15.97', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '11.63', 'groupId': 'OG001'}]}]}, {'title': 'M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.4', 'spread': '17.56', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '14.42', 'groupId': 'OG001'}]}]}, {'title': 'M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.9', 'spread': '15.56', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '12.80', 'groupId': 'OG001'}]}]}, {'title': 'M36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '9.10', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '5.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 7, 12, 24 & 36', 'description': "CushingQol is a disease-specific patient-reported outcome instrument. It is a single-domain 12 item Cushing's disease quality of life instrument. The Cushing's syndrome quality of life (CushingQoL) questionnaire is a single domain questionnaire which includes 12 self-report items scored using a five point Likert scale anchored at (1=always/very much and 5=never/not at all). The patient is asked to report what they think or feel about their Cushing's syndrome and how much the illness has interfered in usual activities over the past 4 weeks. The total score is standardized on a 0-100 scale with lower scores indicating a greater impact on quality of life.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Actual Change in SF-12v2 Score From Baseline - Mental Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'title': 'M7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '8.81', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '8.05', 'groupId': 'OG001'}]}]}, {'title': 'M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '9.97', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '8.26', 'groupId': 'OG001'}]}]}, {'title': 'M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '10.43', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '2.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 7, 12 & 24', 'description': 'SF-12v2 General Health Survey is a general patient reported outcome instrument over time. It is scored to provide eight health domain scores (Bodily Pain (BP), General Health (GH), Physical Functioning (PF), Role-Physical (RP), Social Functioning (SF), Role-Emotional (RE), Vitality (VT) and Mental Health (MH)). These eight domain scores can be combined to form two summary scores reflecting overall physical and mental health: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The analyses reported here focus on PCS and MCS scores. The domain scores use a norm-based score, which standardizes the scores with respect to the mean and standard deviation of a nationally representative sample of United States (US) adults. These are the scores on the original scale which have not been transformed in any way. The possible range of scores is 0 to 100, with higher scores representing better outcomes.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Actual Change in SF-12v2 Score From Baseline - Physical Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'OG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'classes': [{'title': 'M7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '8.50', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '7.46', 'groupId': 'OG001'}]}]}, {'title': 'M12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': '5.56', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '6.73', 'groupId': 'OG001'}]}]}, {'title': 'M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '4.32', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '5.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 7, 12 & 24', 'description': 'SF-12v2 General Health Survey is a general patient reported outcome instrument over time. It is scored to provide eight health domain scores (Bodily Pain (BP), General Health (GH), Physical Functioning (PF), Role-Physical (RP), Social Functioning (SF), Role-Emotional (RE), Vitality (VT) and Mental Health (MH)). These eight domain scores can be combined to form two summary scores reflecting overall physical and mental health: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The analyses reported here focus on PCS and MCS scores. The domain scores use a norm-based score, which standardizes the scores with respect to the mean and standard deviation of a nationally representative sample of United States (US) adults. These are the scores on the original scale which have not been transformed in any way. The possible range of scores is 0 to 100, with higher scores representing better outcomes.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'FG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'DC Dur Core Phs at/Prior to Data Cutoff', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Completed Core Phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'Completed Core/Did Not Enter Ext. Phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Completed Core Phase/Entered Ext. Phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'DC Dur Ext Phs at/Prior to Data Cutoff', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'Completed Extension Phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '48'}]}], 'dropWithdraws': [{'type': 'Abnormal laboratory value(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '19'}]}]}], 'recruitmentDetails': 'At least 148 patients (Pts.) were planned \\& 150 were randomized \\& analyzed. Pts. were all treated with either pasireotide long-acting 10 mg or pasireotide long-acting 30 mg. 81 Pts. completed the Core phase \\& entered the Extension phase with 39 completing the Extension phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '10 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 10 mg of Pasireotide LAR.'}, {'id': 'BG001', 'title': '30 mg Pasireotide LAR Dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. These patients were dosed with 30 mg of Pasireotide LAR.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.3', 'spread': '12.52', 'groupId': 'BG000'}, {'value': '38.6', 'spread': '12.99', 'groupId': 'BG001'}, {'value': '38.5', 'spread': '12.72', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-25', 'studyFirstSubmitDate': '2011-06-14', 'resultsFirstSubmitDate': '2017-12-11', 'studyFirstSubmitQcDate': '2011-06-15', 'lastUpdatePostDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-13', 'studyFirstPostDateStruct': {'date': '2011-06-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Participants That Attained a mUFC ≤ 1.0 x ULN at Month 7 Regardless of Dose Titration', 'timeFrame': 'Month 7', 'description': 'Percentage of participants that attained a mean urinary free cortisol (mUFC) \\<= 1.0 x upper limit of normal (ULN) at Month 7 regardless of dose up-titration at Month 4. Patients who discontinued before month 4 evaluations classed as non-responders. For patients missing month 7 mUFC assessments, the last available mUFC assessment at or after month 4 was carried forward as the month 7 mUFC assessment value.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants That Attained a mUFC ≤ 1.0 x ULN at Month 7 and Had Not Had a Dose Increase at Month 4', 'timeFrame': 'Month 7', 'description': 'Percentage of participants that attain a mUFC ≤ 1.0×ULN at Month 7 and had not had a dose increase at Month 4. Patients who had a dose increase prior to Month 7 were counted as non-responders in this analysis.\n\nPatients who discontinued before month 4 evaluations classed as non-responders. For patients missing month 7 mUFC assessments, the last available mUFC assessment at or after month 4 was carried forward as the month 7 mUFC assessment value.\n\nA responder was defined as a patient who attains mUFC ≤1.0 X ULN and had not had a dose increase at Month 4.'}, {'measure': 'Actual Change in Mean Urinary Free Cortisol (mUFC) From Baseline', 'timeFrame': 'baseline, Month 7 (M7), Month 12 (M12), Month 24 (M24) , Month 36 (M36)', 'description': 'Actual change in mUFC (nmol/24h) from baseline by randomized groups.'}, {'measure': 'Percentage Change in Mean Urinary Free Cortisol (mUFC) From Baseline', 'timeFrame': 'M7, M12, M24, M36', 'description': 'Percentage change in mUFC (nmol/24h) from baseline by randomized groups.'}, {'measure': 'Percentage of Patients Who Attain mUFC ≤ 1.0 x ULN', 'timeFrame': 'M7, M12, M24, M36', 'description': 'Controlled responder: mUFC ≤ 1.0×ULN by randomized groups.'}, {'measure': 'Percentage of Patients Who Attain mUFC ≤1.0 x ULN or Have at Least 50 % Reduction From Baseline in mUFC', 'timeFrame': 'M7, M12, M24, M36', 'description': 'Controlled responder: mUFC ≤ 1.0×ULN. Partially controlled responder: at least 50% reduction in mUFC from Baseline, and mUFC \\>1.0×ULN.'}, {'measure': 'Percentage of Patients Who Are Controlled Responders (mUFC ≤ 1.0 xULN) on at Least 4 of the 7 mUFC Assessments by Month 7 & on at Least 7 of the 12 mUFC Assessments by Month 12.', 'timeFrame': 'Month 7, Month 12', 'description': 'Percentage of patients with mUFC ≤ 1.0 x ULN at a minimum of 4 months up to and including Month 7, and at a minimum of 7 months up to and including Month 12 by randomized groups.'}, {'measure': 'Percentage of Patients With Uncontrolled Response at Month 7 & Month 12 Within the Subset of Patients Who Had Uncontrolled Response at a) Months 1 and 2; b) Months 1, 2, and 3', 'timeFrame': 'Month 7, Month12', 'description': 'Percentage of patients with mUFC \\> 1.0 xULN at Month 7 and Month 12 within the subset of patients who were uncontrolled at a) Months 1 \\& 2, b) Months 1, 2, \\& 3 by randomized groups.'}, {'measure': 'Percent of Participants Attaining a mUFC ≤ 1.0 x ULN or at Least a 50% Reduction in mUFC From Baseline at Indicated Time Points', 'timeFrame': 'Momth 7, Month 12', 'description': 'Time to first achievement of attaining a mUFC ≤ 1.0 x ULN or at least a 50% reduction in mUFC from baseline by randomized groups.'}, {'measure': 'Percent of Participants Attaining a Duration of Controlled or Partially Controlled Response at Indicated Time Points', 'timeFrame': 'Month 6, 12, 18', 'description': "Duration of controlled or partially controlled response is defined as the period starting from the date of patient's first normalization (mUFC≤ 1.0 x ULN) or at least 50% reduction from baseline up to the date when the patient's mUFC \\>1.0 x ULN and the reduction from baseline falls to less than 50% for the first time."}, {'measure': 'Percentage Change From Baseline on Plasma Adrenocorticotropic Hormone (ACTH) Over Time', 'timeFrame': 'Months 7, 12, 24 & 36', 'description': 'Percentage change in ACTH (pmol/L) from Baseline by randomized groups.'}, {'measure': 'Percentage Change From Baseline on Serum Cortisol Over Time', 'timeFrame': 'Months 7, 12, 24 & 36', 'description': 'Percentage change in serum cortisol (nmol/L) from Baseline by randomized groups.'}, {'measure': 'Actual Change From Baseline in Clinical Signs Over Time: Blood Pressure', 'timeFrame': 'Month 7', 'description': 'Change in blood pressure measurements from Baseline'}, {'measure': 'Actual Change From Baseline in Clinical Signs Over Time: Body Mass Index (BMI)', 'timeFrame': 'Month 7', 'description': 'Change in BMI measurements from Baseline'}, {'measure': 'Actual Change From Baseline in Clinical Signs Over Time: Weight', 'timeFrame': 'Month 7', 'description': 'Change in weight measurements from Baseline'}, {'measure': 'Actual Change From Baseline in Clinical Signs Over Time: Body Composition: Region', 'timeFrame': 'Month 7', 'description': 'Change in body composition: region measurements from Baseline'}, {'measure': 'Actual Change From Baseline in Clinical Signs Over Time: Waist Circumference', 'timeFrame': 'Month 7', 'description': 'Change in waist circumference measurements from Baseline'}, {'measure': 'Actual Change From Baseline in Clinical Signs Over Time: Cholesterol & Triglycerides', 'timeFrame': 'Month 7', 'description': 'Change in parameter measurements: cholesterol \\& triglycerides from Baseline'}, {'measure': 'Percentage Change From Baseline in Clinical Signs Over Time', 'timeFrame': 'Month 7', 'description': 'Percentage change in parameter measurements: blood pressure, body mass index, waist circumference, fasting serum lipid profile, weight, bone density and body composition (examined by DXA scan) from Baseline'}, {'measure': 'Percentage of Participants Having a Favorable Shift From Baseline in Clinical Signs', 'timeFrame': 'Month 7', 'description': 'This includes patients with improvements in symptoms from baseline. Clinical signs over time include: facial rubor, fat pads, hirsutism, striae, (via photographs by a second local physician who was blinded to the treatment dose and time point of the photograph) and muscle strength.'}, {'measure': 'Percentage of Participants That Attained a Mean Urinary Free Cortisol (mUFC) <= 1.0 x Upper Limit of Normal (ULN) at Month 7 Regardless of Dose Up-titration at Month 4.', 'timeFrame': 'Month 7', 'description': 'All of the participants who discontinued prior to month 4 evaluations were classed as non-responders. For participants missing month 7 mUFC assessments, the last available mUFC assessment at or after month 4 was carried forward as the month 7 mUFC assessment value.\n\nAnalysis split by screening strata of mUFC Stratum 1: mUFC 1.5x to \\< 2.0 x ULN Stratum 2: mUFC 2.0x to \\<= 5.0 x ULN'}, {'measure': 'Percentage of Patients That Attain a Reduction of at Least 50% in mUFC From Baseline', 'timeFrame': 'Months 7, 12, 24 & 36', 'description': 'All of the participants who discontinued prior to month 4 evaluations were classed as non-responders. For participants missing month 7 mUFC assessments, the last available mUFC assessment at or after month 4 was carried forward as the month 7 mUFC assessment value.\n\nAnalysis split by screening strata of mUFC\n\nStratum 1:'}, {'measure': 'Percent of Participants Attaining a Time to First Achievement of at Least a 50% Reduction in mUFC From Baseline at Indicated Time Points', 'timeFrame': 'every month in the core phase and every 3 months in the extension phase) up to and including the cut-off date for the Month 12 CSR (10-Nov-2015)', 'description': 'Time to first achievement of a 5by randomized groups.0% reduction in mUFC from baseline'}, {'measure': 'Percent of Participants With a Duration of at Least 50% Reduction in mUFC From Baseline at Indicated Time Points', 'timeFrame': 'Months 6, 12 & 18', 'description': "Duration of 50% reduction from baseline is defined as the period starting from the date of patient's first 50% reduction from baseline"}, {'measure': 'Pharmacokinetic (PK) Parameter: Ctrough', 'timeFrame': 'Days 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337', 'description': 'Pasireotide trough levels (Ctrough) was 1 of the parameters used for PK assessments. Ctrough is the pre-dose PK concentration with an elapsed time from previous injection of 28+/-2 days. All patients randomized to the study had at least 1 PK observation \\& were therefore included in the pharmacokinetic analysis set. PK observations with missing concentrations, missing dose, missing elapsed time or an elapsed time from previous injection outside of 28 ±2 days window were excluded. Given that SOM230 LAR was administered once a month, Ctrough was collected every 28 days and thus this provides a summary of Ctrough values provided by incident dose (last dose administered prior to PK sample collection), not by randomized dose, hence each column is equivalent to an incident dose \\& not an arm/group. Patients randomized to either 10mg or 30mg could be titrated down to 5mg due to safety, or titrated up to 40mg, hence the 4 incident doses/columns that were allowed per protocol during this study.'}, {'measure': 'Pharmacokinetic (PK) Parameter: Cmax', 'timeFrame': 'Days 22, 106, 190', 'description': 'Pasireotide peak levels (Cmax) was one of the parameters used for PK assessments. Cmax is the post-dose PK concentration with an elapsed time from the previous injection of 21+/-2 days. All patients randomized to the study had at least one PK observation and were therefore included in the pharmacokinetic analysis set (PAS). Cmax PK observations ("Day 20" and "Day 104") with an elapsed time from the previous injection outside of 21+/-2 days window were excluded. Given that SOM230 LAR was administered once a month, the Cmax were collected every 28 days in this study, thus this provides a summary of Cmax values provided by incident dose (last dose administered prior to PK sample collection), not by randomized dose, hence each column is equivalent to an incident dose and not an arm/group. Patients randomized to either the 10mg or 30mg could be titrated down to 5mg due to safety, or titrated up to 40mg, hence the 4 incident doses/columns that were allowed per protocol during this study.'}, {'measure': "Actual Change in Standardized Score of Cushing's Disease HRQoL (CushingQOL) Score From Baseline", 'timeFrame': 'Months 7, 12, 24 & 36', 'description': "CushingQol is a disease-specific patient-reported outcome instrument. It is a single-domain 12 item Cushing's disease quality of life instrument. The Cushing's syndrome quality of life (CushingQoL) questionnaire is a single domain questionnaire which includes 12 self-report items scored using a five point Likert scale anchored at (1=always/very much and 5=never/not at all). The patient is asked to report what they think or feel about their Cushing's syndrome and how much the illness has interfered in usual activities over the past 4 weeks. The total score is standardized on a 0-100 scale with lower scores indicating a greater impact on quality of life."}, {'measure': 'Actual Change in SF-12v2 Score From Baseline - Mental Component Summary', 'timeFrame': 'Months 7, 12 & 24', 'description': 'SF-12v2 General Health Survey is a general patient reported outcome instrument over time. It is scored to provide eight health domain scores (Bodily Pain (BP), General Health (GH), Physical Functioning (PF), Role-Physical (RP), Social Functioning (SF), Role-Emotional (RE), Vitality (VT) and Mental Health (MH)). These eight domain scores can be combined to form two summary scores reflecting overall physical and mental health: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The analyses reported here focus on PCS and MCS scores. The domain scores use a norm-based score, which standardizes the scores with respect to the mean and standard deviation of a nationally representative sample of United States (US) adults. These are the scores on the original scale which have not been transformed in any way. The possible range of scores is 0 to 100, with higher scores representing better outcomes.'}, {'measure': 'Actual Change in SF-12v2 Score From Baseline - Physical Component Summary', 'timeFrame': 'Months 7, 12 & 24', 'description': 'SF-12v2 General Health Survey is a general patient reported outcome instrument over time. It is scored to provide eight health domain scores (Bodily Pain (BP), General Health (GH), Physical Functioning (PF), Role-Physical (RP), Social Functioning (SF), Role-Emotional (RE), Vitality (VT) and Mental Health (MH)). These eight domain scores can be combined to form two summary scores reflecting overall physical and mental health: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The analyses reported here focus on PCS and MCS scores. The domain scores use a norm-based score, which standardizes the scores with respect to the mean and standard deviation of a nationally representative sample of United States (US) adults. These are the scores on the original scale which have not been transformed in any way. The possible range of scores is 0 to 100, with higher scores representing better outcomes.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SOM230', "Cushing's Disease", 'Mean Urinary Free Cortisol', 'Pasireotide', 'Pasireotide LAR', 'Pasireotide long-acting release', 'secondary hypercortisolism', 'secondary hypercorticism', 'Itsenko-Cushing disease', 'increased secretion of adrenocorticotropic hormone (ACTH)', 'hyperpituitarism'], 'conditions': ["Cushing's Disease"]}, 'referencesModule': {'references': [{'pmid': '32385851', 'type': 'DERIVED', 'citation': "Lacroix A, Bronstein MD, Schopohl J, Delibasi T, Salvatori R, Li Y, Barkan A, Suzaki N, Tauchmanova L, Ortmann CE, Ravichandran S, Petersenn S, Pivonello R. Long-acting pasireotide improves clinical signs and quality of life in Cushing's disease: results from a phase III study. J Endocrinol Invest. 2020 Nov;43(11):1613-1622. doi: 10.1007/s40618-020-01246-0. Epub 2020 May 8."}, {'pmid': '31804965', 'type': 'DERIVED', 'citation': "Newell-Price J, Pivonello R, Tabarin A, Fleseriu M, Witek P, Gadelha MR, Petersenn S, Tauchmanova L, Ravichandran S, Gupta P, Lacroix A, Biller BMK. Use of late-night salivary cortisol to monitor response to medical treatment in Cushing's disease. Eur J Endocrinol. 2020 Feb;182(2):207-217. doi: 10.1530/EJE-19-0695."}, {'pmid': '31465533', 'type': 'DERIVED', 'citation': "Fleseriu M, Petersenn S, Biller BMK, Kadioglu P, De Block C, T'Sjoen G, Vantyghem MC, Tauchmanova L, Wojna J, Roughton M, Lacroix A, Newell-Price J. Long-term efficacy and safety of once-monthly pasireotide in Cushing's disease: A Phase III extension study. Clin Endocrinol (Oxf). 2019 Dec;91(6):776-785. doi: 10.1111/cen.14081. Epub 2019 Oct 1."}, {'pmid': '29032078', 'type': 'DERIVED', 'citation': "Lacroix A, Gu F, Gallardo W, Pivonello R, Yu Y, Witek P, Boscaro M, Salvatori R, Yamada M, Tauchmanova L, Roughton M, Ravichandran S, Petersenn S, Biller BMK, Newell-Price J; Pasireotide G2304 Study Group. Efficacy and safety of once-monthly pasireotide in Cushing's disease: a 12 month clinical trial. Lancet Diabetes Endocrinol. 2018 Jan;6(1):17-26. doi: 10.1016/S2213-8587(17)30326-1. Epub 2017 Oct 12."}, {'pmid': '27405306', 'type': 'DERIVED', 'citation': "Silverstein JM. Hyperglycemia induced by pasireotide in patients with Cushing's disease or acromegaly. Pituitary. 2016 Oct;19(5):536-43. doi: 10.1007/s11102-016-0734-1."}]}, 'descriptionModule': {'briefSummary': "This is a randomized, double-blind, multicenter, phase III study to evaluate the safety and efficacy of 2 dosing regiments of Pasireotide long acting release (LAR) in patients with Cushing's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Karnofsky performance status ≥ 60 (i.e. requires occasional assistance, but is able to care for most of their personal needs)\n* For patients on medical treatment for Cushing's disease the following washout periods must be completed before screening assessments are performed\n\n * Inhibitors of steroidogenesis (ketoconazole, metyrapone): 1 week\n * Pituitary directed agents: Dopamine agonists (bromocriptine, cabergoline) and PPARγ agonists (rosiglitazone or pioglitazone): 4 weeks\n * Octreotide LAR, Lanreotide SR and Lanreotide autogel: 14 weeks\n * Octreotide (immediate release formulation): 1 week\n\nExclusion Criteria:\n\n* Patients who are considered candidates for surgical treatment at the time of study entry\n* Patients who have received pituitary irradiation within the last ten years prior to visit 1\n* Patients who have had any previous pasireotide treatment\n* Patients who have been treated with mitotane during the last 6 months prior to Visit 1\n* Diabetic patients on antihyperglycemic medications with poor glycemic control as evidenced by HbA1c \\>8%\n* Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF \\>470 ms, hypokalemia, uncontrolled hypothyroidism, family history of long QT syndrome, or concomitant medications known to prolong QT interval\n* Female patients who are pregnant or lactating, or are of childbearing potential (defined as all women physiologically capable of becoming pregnant) and not practicing an effective method of contraception/birth control. Sexually active males must use a condom during intercourse while taking the drug and for 2 months after the last dose of study drug and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid"}, 'identificationModule': {'nctId': 'NCT01374906', 'briefTitle': "Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': "A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Pasireotide LAR in Patients With Cushing's Disease", 'orgStudyIdInfo': {'id': 'CSOM230G2304'}, 'secondaryIdInfos': [{'id': '2009-011128-70', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '10 mg LAR dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms.', 'interventionNames': ['Drug: pasireotide LAR', 'Drug: SOM230 LAR 10 mg']}, {'type': 'EXPERIMENTAL', 'label': '30 mg LAR dose', 'description': 'Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms.', 'interventionNames': ['Drug: pasireotide LAR', 'Drug: SOM230 LAR 30 mg']}], 'interventions': [{'name': 'pasireotide LAR', 'type': 'DRUG', 'otherNames': ['SOM230'], 'description': 'Pasireotide long-acting was administered as an intra-muscular depot intragluteal injection once every 28 days (±2 days). Patients were administered pasireotide long-acting 10 mg or 30 mg for four months, followed by either continuation of the starting dose, or dose up-titration (if mUFC was still \\>1.5xULN unless titration was precluded by safety reasons).', 'armGroupLabels': ['10 mg LAR dose', '30 mg LAR dose']}, {'name': 'SOM230 LAR 30 mg', 'type': 'DRUG', 'description': 'starting dose of 30 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of starting dose.', 'armGroupLabels': ['30 mg LAR dose']}, {'name': 'SOM230 LAR 10 mg', 'type': 'DRUG', 'description': 'starting does of SOM230 LAR 10 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of the starting dose.', 'armGroupLabels': ['10 mg LAR dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85381', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'ClinTriCo', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Los Angeles UCLA Tiverton', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90509', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor-UCLA Medical Center LA Biomed', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine/Winship Cancer Institute G2304 - C2301', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Pituitary Center, Division of Endocrinology SC', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48109-0944', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Comprehensive Cancer Center SC-2', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine Mt. 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