Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-02-22 @ 6:45 PM
Study NCT ID:
NCT02468193
Status:
COMPLETED
Last Update Posted:
2020-05-06
First Post:
2015-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003480', 'term': 'Cushing Syndrome'}, {'id': 'D000182', 'term': 'ACTH Syndrome, Ectopic'}, {'id': 'D000306', 'term': 'Adrenal Cortex Neoplasms'}, {'id': 'C565662', 'term': 'Acth-Independent Macronodular Adrenal Hyperplasia'}], 'ancestors': [{'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009384', 'term': 'Paraneoplastic Endocrine Syndromes'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000310', 'term': 'Adrenal Gland Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D000303', 'term': 'Adrenal Cortex Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C553306', 'term': 'Osilodrostat'}]}}, '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}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 68.0 weeks.', 'description': 'AE description; Any sign or symptom that occurs during the study treatment plus the 30 days post treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Osilodrostat', 'description': 'Patients in this arm took the study drug, osilodrostat.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 5}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Steroid withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Primary biliary cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Mood altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Nightmare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Reactive psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Peripheral coldness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Psychiatric symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in the Mean Urine Free Cortisol (mUFC) at the Individual Level at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Osilodrostat', 'description': 'Patients in this arm took the study drug, osilodrostat.'}], 'classes': [{'title': 'AIMAH- Patient 1 (n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-99.0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma - Patient 1 (n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-97.8', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma - Patient 2 (n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-94.5', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma - Patient 3 (n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-91.5', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma - Patient 4 (n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-81.8', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma - Patient 5 (n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-52.6', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome - Patient 1 (n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-99.0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic c orticotropin syndrome - Patient 2(n=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome - Patient 3 (n=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Percent change from baseline in the mUFC at the individual patient level', 'unitOfMeasure': 'percentage change', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in the mUFC at Individual Patient Level at Week 24 (Day 169) and Week 48 (Day 337)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Osilodrostat', 'description': 'Patients in this arm took the study drug, osilodrostat.'}], 'classes': [{'title': 'AIMAH-Patient (Pt) 1: Week (Wk) 24 (n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-99.5', 'groupId': 'OG000'}]}]}, {'title': 'AIMAH-Patient 1:Wk 48 (n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-99.1', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 1: Wk 24(n=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 1: Wk 48(n=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 2: Wk 24(n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-85.2', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 2: Wk 48(n=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 3: Wk 24(n=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 3: Wk 48(n=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 4: Wk 24(n=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 4: Wk 48(n=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 5: Wk 24(n=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 5: Wk 48(n=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 1: Wk 24(n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-91.6', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 1: Wk 48(n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-91.0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 2: Wk 24(n=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 2: Wk 48(n=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 3: Wk 24(n=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 3: Wk 48(n=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24 (day 169) and Week 48 (day 337)', 'description': 'Percent change from baseline in the mUFC at the individual patient level', 'unitOfMeasure': 'percentage change', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in the mUFC at Week 12 (Day 85), Week 24 (Day 169) and Week 48 (Day 337)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Osilodrostat', 'description': 'Patients in this arm took the study drug, osilodrostat.'}], 'classes': [{'title': 'Week 12 (day 85)( n = 7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-422.10', 'groupId': 'OG000', 'lowerLimit': '-10487.5', 'upperLimit': '-157.0'}]}]}, {'title': 'Week 24 (day 169) (n = 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7428.10', 'groupId': 'OG000', 'lowerLimit': '-9702.0', 'upperLimit': '-367.9'}]}]}, {'title': 'Week 48 (day 337) (n = 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8521.00', 'groupId': 'OG000', 'lowerLimit': '-9640.5', 'upperLimit': '-7401.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': 'Absolute change from baseline in the mUFC', 'unitOfMeasure': 'nmol/24hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in the mUFC at Week 12 (Day 85), Week 24 (Day 169) and Week 48 (Day 337)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Osilodrostat', 'description': 'Patients in this arm took the study drug, osilodrostat.'}], 'classes': [{'title': 'Week 12 (day 85)( n = 7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-94.47', 'groupId': 'OG000', 'lowerLimit': '-99.0', 'upperLimit': '-52.6'}]}]}, {'title': 'Week 24 (day 169) (n = 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-91.57', 'groupId': 'OG000', 'lowerLimit': '-99.5', 'upperLimit': '-85.2'}]}]}, {'title': 'Week 48 (day 337) (n = 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-95.04', 'groupId': 'OG000', 'lowerLimit': '-99.1', 'upperLimit': '-91.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': 'Percent change from baseline in the mUFC', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With mUFC Response of Complete, Partial, and Overall Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Osilodrostat', 'description': 'Patients in this arm took the study drug, osilodrostat.'}], 'classes': [{'title': 'Week 12: Complete responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '29.9', 'upperLimit': '92.5'}]}]}, {'title': 'Week 12: Partial responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '48.2'}]}]}, {'title': 'Week 12: Overall responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000', 'lowerLimit': '40.0', 'upperLimit': '97.2'}]}]}, {'title': 'Week 24: Complete responders (n =3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '99.2'}]}]}, {'title': 'Week 24: Partial responders (n = 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '90.6'}]}]}, {'title': 'Week 24: Overall responders (n = 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '29.2', 'upperLimit': '100.0'}]}]}, {'title': 'Week 48: Complete responders (n = 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Week 48: Partial responders (n = 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Week 48: Overall responders (n = 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12, 24 and 48 weeks', 'description': 'Complete response rate = percentage of participants who had mUFC≤ ULN; Partial response rate = Percentage of participants who had mUFC\\>ULN and at least 50% reduction from baseline in mUFC. Overall response rate = Percentage of participants who had mUFC ≤ ULN or at least 50% reduction from baseline.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Morning Serum Cortisol at Individual Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Osilodrostat', 'description': 'Patients in this arm took the study drug, osilodrostat.'}], 'classes': [{'title': 'AIMAH-Patient (Pt) 1: Week (Wk) 12 (n = 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-607', 'groupId': 'OG000'}]}]}, {'title': 'AIMAH-Patient 1: Wk 24 (n = 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-571', 'groupId': 'OG000'}]}]}, {'title': 'AIMAH-Patient 1: Wk 48 (n = 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-580', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 1: Wk 12 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-334', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 1:Wk 24 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 1: Wk 48 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 2: Wk 12(n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-157', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 2: Wk 24 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-135', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 2: Wk 48 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 3: Wk 12 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-300', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 3: Wk 24 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 3: Wk 48 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 4: Wk 12 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-30', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 4: Wk 24 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 4: Wk 48 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 5: Wk 12 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 5: Wk 24 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 5: Wk 48 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 1: Wk 12 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-949', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 1: Wk24 (n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-927', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 1: Wk48 (n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-861', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 2: Wk 12 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 2: Wk 24 (n=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 2: Wk48 (n=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 3: Wk 12 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 3: Wk24 (n=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 3: Wk48 (n=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': 'Absolute change from baseline in morning serum cortisol at the individual patient level', 'unitOfMeasure': 'nmol/L', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Morning Serum Cortisol at Individual Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Osilodrostat', 'description': 'Patients in this arm took the study drug, osilodrostat.'}], 'classes': [{'title': 'AIMAH-Patient (Pt) 1: Week (Wk) 12 (n = 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-73.3', 'groupId': 'OG000'}]}]}, {'title': 'AIMAH-Patient 1: Wk 24 (n = 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-69.0', 'groupId': 'OG000'}]}]}, {'title': 'AIMAH-Patient 1: Wk 48 (n = 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-70.0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 1: Wk 12 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-78.0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 1:Wk 24 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 1: Wk 48 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 2: Wk 12(n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-50.8', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 2: Wk 24 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-43.7', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 2: Wk 48 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 3: Wk 12 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-56.1', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 3: Wk 24 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 3: Wk 48 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 4: Wk 12 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.7', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 4: Wk 24 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 4: Wk 48 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 5: Wk 12 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 5: Wk 24 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 5: Wk 48 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 1: Wk 12 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-71.4', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 1: Wk24 (n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-69.7', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 1: Wk48 (n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-64.7', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 2: Wk 12 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 2: Wk24 (n=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 2: Wk48 (n=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 3: Wk 12 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 3: Wk24 (n=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 3: Wk48 (n=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': 'Percentage change from baseline in morning serum cortisol at the individual patient level', 'unitOfMeasure': 'percentage change', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in ACTH and Other Adrenal Steroid Hormones at Individual Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTH', 'description': 'Adrenocorticotropic hormone'}, {'id': 'OG001', 'title': 'Serum 11-deoxycorticosterone', 'description': 'adrenal steroid hormones: Serum 11-deoxycorticosterone'}, {'id': 'OG002', 'title': 'Aldosterone', 'description': 'adrenal steroid hormones: Aldosterone'}, {'id': 'OG003', 'title': 'Estradiol', 'description': 'adrenal steroid hormones: Estradiol'}], 'classes': [{'title': 'AIMAH-Patient (Pt) 1 Wk 12 (n=1,1,1,1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2179', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '705', 'groupId': 'OG003'}]}]}, {'title': 'AIMAH-Pt 1 Wk 24 (n=1,1,1,1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3601', 'groupId': 'OG001'}, {'value': '236', 'groupId': 'OG002'}, {'value': '235', 'groupId': 'OG003'}]}]}, {'title': 'AIMAH-Pt 1 Wk 48 (n=1,1,1,1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '400', 'groupId': 'OG003'}]}]}, {'title': 'Adrenal adenoma-Pt 1 Wk 12 (n=1,1,1,1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '2966', 'groupId': 'OG001'}, {'value': '-27', 'groupId': 'OG002'}, {'value': '-404', 'groupId': 'OG003'}]}]}, {'title': 'Adrenal adenoma-Pt 1 Wk 24 (n =0,0,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Adrenal adenoma-Pt 1 Wk 48 (n=0,0,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Adrenal adenoma-Pt 2 Wk 12 (n=1,1,1,1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5145', 'groupId': 'OG001'}, {'value': '-981', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Adrenal adenoma-Pt 2 Wk 24(n=1,1,1,1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '450', 'groupId': 'OG002'}, {'value': '-4', 'groupId': 'OG003'}]}]}, {'title': 'Adrenal adenoma-Pt 2 Wk 48 (n=0,0,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Adrenal adenoma-Pt 3 Wk 12 (n=1,1,1,1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '-147', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}]}, {'title': 'Adrenal adenoma-Pt 3 Wk 24 (n=0, 0,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Adrenal adenoma-Pt 3 Wk 48(n=0,0,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Adrenal adenoma-Pt 4 Wk 12 (n=1,1,1,1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '787', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'Adrenal adenoma-Pt 4 Wk 24 (n=0,0,0,0)', 'denoms': [{'units': 'Participants', 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[{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Adrenal adenoma-Pt 3 Wk 12 (n=1,1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.3', 'groupId': 'OG000'}, {'value': '-8.9', 'groupId': 'OG001'}]}]}, {'title': 'Adrenal adenoma-Pt 3 Wk 24 (n=0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Adrenal adenoma-Pt 3 Wk 48 (n=0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Adrenal adenoma-Pt 4 Wk 12 (n=1,1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.3', 'groupId': 'OG000'}, {'value': '9.9', 'groupId': 'OG001'}]}]}, {'title': 'Adrenal adenoma-Pt 4 Wk 24 (n=0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Adrenal adenoma-Pt 4 Wk 48 (n=0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Adrenal adenoma-Pt 5 Wk 12 (n=1,1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'Adrenal adenoma-Pt 5 Wk 24 (n=0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Adrenal adenoma-Pt 5 Wk 48 (n=0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ectopic ACTH syndrome-Pt 1 Wk 12(n=1,1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.1', 'groupId': 'OG000'}, {'value': '-16.5', 'groupId': 'OG001'}]}]}, {'title': 'Ectopic ACTH syndrome-Pt 1 Wk 24 (n=1,1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '4.8', 'groupId': 'OG001'}]}]}, {'title': 'Ectopic ACTH syndrome-Pt 1 Wk 48 (n=1,1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000'}, {'value': '-0.8', 'groupId': 'OG001'}]}]}, {'title': 'Ectopic ACTH syndrome-Pt 2 Wk 12 (n=0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ectopic ACTH syndrome-Pt 2 Wk 24 (n=0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ectopic ACTH syndrome-Pt 2 Wk 48 (n=0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ectopic ACTH syndrome-Pt 3 Wk 12 (n=0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ectopic ACTH syndrome-Pt 3 Wk 24 (n=0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ectopic ACTH syndrome-Pt 3 Wk 48 (n=0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': "Percentage change in cardiovascular-related metabolic parameter: sitting systolic BP \\& sitting diastolic BP, associated with Cushing's syndrome", 'unitOfMeasure': 'percentage change', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.'}, {'type': 'SECONDARY', 'title': 'Total Scores in Patient-Reported Outcomes Health-related Quality of Life (QoL) as Assessed by Cushing QoL at Individual Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Osilodrostat', 'description': 'Patients in this arm took the study drug, osilodrostat.'}], 'classes': [{'title': 'AIMAH-Patient 1: Week (Wk) 12 (n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}, {'title': 'AIMAH-Patient 1: Wk 24 (n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'AIMAH-Patient 1: Wk 48 (n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 1: Wk 12(n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 1: Wk 24 (n = 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 1: Wk 48 (n = 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 2: Wk 12(n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 2: Wk 24 (n = 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 2: Wk 48 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 3: Wk 12 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 3: Wk 24 (n = 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 3: Wk 48 (n = 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 4: Wk 12 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 4: Wk 24 (n = 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 4: Wk 48 (n = 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 5: Wk 12 (n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 5: Wk 24 (n = 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 5: Wk 48 (n = 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 1: Wk 12 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 1: Wk 24 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 1: Wk 48 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 2: Wk 12 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 2: Wk 24 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 2: Wk 48 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 3: Wk 12 n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 3: Wk 24 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 3: Wk 48 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': "The Cushing's Disease Health-Related Quality of Life Questionnaire (Cushing QoL) (version 1.0) was developed to evaluate quality of life in patients with Cushing's syndrome (Webb et al 2008). The Cushing QoL is comprised of 12 items that capture patient responses on seven concepts: daily activities, healing and pain, mood and self-confidence, social concerns, physical appearance, memory and concern about the future. Each questionnaire of the Cushing QOL has a scale of 1-5 where '1' corresponding to 'Always' or 'Very much' and '5' to 'Never' or 'Not at all'. The lower the score, the greater the impact on HRQoL. The score is the sum of all the item response and can range from 12 (worst) to 60 points (best).", 'unitOfMeasure': 'scores on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.'}, {'type': 'SECONDARY', 'title': 'Total Scores in Patient-Reported Outcomes Health-related Quality of Life (QoL) as Assessed by Beck Depression Inventory II (BDI-ll) Depression Score at Individual Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Osilodrostat', 'description': 'Patients in this arm took the study drug, osilodrostat.'}], 'classes': [{'title': 'AIMAH-Patient 1: Week (Wk) 12 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'AIMAH-Patient 1: Wk 24 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'AIMAH-Patient 1: Wk 48 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 1: Wk 12 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 1: Wk 24 (n = 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 1: Wk 48 (n = 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 2: Wk 12 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 2: Wk 24 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 2: Wk 48 (n = 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 3: Wk 12 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 3: Wk 24 (n = 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 3: Wk 48 (n = 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 4: Wk 12 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 4: Wk 24 (n = 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 4: Wk 48 (n = 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 5: Wk 12 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 5: Wk 24 (n = 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adrenal adenoma-Patient 5: Wk 48 (n = 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 1: Wk 12 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 1: Wk 24 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 1: Wk 48 (n =1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 2: Wk 12 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 2: Wk 24 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 2: Wk 48 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 3: Wk 12 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 3: Wk 24 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ectopic corticotropin syndrome-Pt 3: Wk 48 (n =0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': 'The Beck Depression Inventory II (BDI-II) is a patient reported instrument that consists of 21 items designed to assess the intensity of depression in clinical \\& normal patients in the preceding two weeks. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. Each of 21 items corresponds to a symptom of depression and the sum of total score will be calculated where each item has a four-point scale ranging from 0 to 3, leading to a total score from zero to 63.', 'unitOfMeasure': 'scores on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Osilodrostat 1mg', 'description': 'Patients in this arm took 1mg of study drug, osilodrostat.'}, {'id': 'OG001', 'title': 'Osilodrostat 2mg', 'description': 'Patients in this arm took 2mg of study drug, osilodrostat.'}, {'id': 'OG002', 'title': 'Osilodrostat 3mg', 'description': 'Patients in this arm took 3mg of study drug, osilodrostat.'}, {'id': 'OG003', 'title': 'Osilodrostat 5mg', 'description': 'Patients in this arm took 5mg of study drug, osilodrostat.'}], 'classes': [{'title': 'Week 0: 0.75 hour post-dose', 'categories': [{'measurements': [{'value': '0.971', 'spread': 'NA', 'comment': 'N/A : not enough participants to calculate the standard deviation', 'groupId': 'OG000'}, {'value': '0.405', 'spread': '0.673', 'groupId': 'OG001'}]}]}, {'title': 'Week 0: 2 hours post-dose', 'categories': [{'measurements': [{'value': '5.11', 'spread': 'NA', 'comment': 'N/A : not enough participants to calculate the standard deviation', 'groupId': 'OG000'}, {'value': '5.29', 'spread': '4.94', 'groupId': 'OG001'}]}]}, {'title': 'Week 0: 4 hours post-dose', 'categories': [{'measurements': [{'value': '3.77', 'spread': 'NA', 'comment': 'N/A : not enough participants to calculate the standard deviation', 'groupId': 'OG000'}, {'value': '8.12', 'spread': '2.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Osilodrostat 1mg', 'description': 'Patients in this arm took 1mg of study drug, osilodrostat.'}, {'id': 'OG001', 'title': 'Osilodrostat 2mg', 'description': 'Patients in this arm took 2mg of study drug, osilodrostat.'}, {'id': 'OG002', 'title': 'Osilodrostat 3mg', 'description': 'Patients in this arm took 3mg of study drug, osilodrostat.'}, {'id': 'OG003', 'title': 'Osilodrostat 5mg', 'description': 'Patients in this arm took 5mg of study drug, osilodrostat.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'spread': 'NA', 'comment': 'N/A : not enough participants to calculate the standard deviation', 'groupId': 'OG000'}, {'value': '10.5', 'spread': '6.57', 'groupId': 'OG001'}, {'value': '21.3', 'spread': 'NA', 'comment': 'N/A : not enough participants to calculate the standard deviation', 'groupId': 'OG002'}, {'value': '22.3', 'spread': '14.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1, 2 hours post-dose', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Osilodrostat 1mg', 'description': 'Patients in this arm took 1mg of study drug, osilodrostat.'}, {'id': 'OG001', 'title': 'Osilodrostat 2mg', 'description': 'Patients in this arm took 2mg of study drug, osilodrostat.'}, {'id': 'OG002', 'title': 'Osilodrostat 3mg', 'description': 'Patients in this arm took 3mg of study drug, osilodrostat.'}, {'id': 'OG003', 'title': 'Osilodrostat 5mg', 'description': 'Patients in this arm took 5mg of study drug, osilodrostat.'}], 'classes': [{'title': 'Week 2: 0.75 hour post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.89', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '3.69', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '33.1', 'spread': '19.2', 'groupId': 'OG002'}, {'value': '34.9', 'spread': '34.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 2: 2 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.93', 'spread': '2.36', 'groupId': 'OG000'}, {'value': '14.3', 'spread': '7.64', 'groupId': 'OG001'}, {'value': '21.3', 'spread': '4.53', 'groupId': 'OG002'}, {'value': '33.6', 'spread': '8.84', 'groupId': 'OG003'}]}]}, {'title': 'Week 2: 4 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.01', 'spread': '2.69', 'groupId': 'OG000'}, {'value': '11.1', 'spread': 'NA', 'comment': 'N/A : not enough participants to calculate the standard deviation', 'groupId': 'OG001'}, {'value': '13.6', 'spread': '3.89', 'groupId': 'OG002'}, {'value': '29.2', 'spread': '0.354', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Osilodrostat 1mg', 'description': 'Patients in this arm took 1mg of study drug, osilodrostat.'}, {'id': 'OG001', 'title': 'Osilodrostat 2mg', 'description': 'Patients in this arm took 2mg of study drug, osilodrostat.'}, {'id': 'OG002', 'title': 'Osilodrostat 3mg', 'description': 'Patients in this arm took 3mg of study drug, osilodrostat.'}, {'id': 'OG003', 'title': 'Osilodrostat 5mg', 'description': 'Patients in this arm took 5mg of study drug, osilodrostat.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.09', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '7.62', 'spread': 'NA', 'comment': 'N/A : not enough participants to calculate the standard deviation', 'groupId': 'OG001'}, {'value': '23.2', 'spread': 'NA', 'comment': 'N/A : not enough participants to calculate the standard deviation', 'groupId': 'OG002'}, {'value': '37.8', 'spread': '0.849', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 3, 2 hours post-dose', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Osilodrostat 1mg', 'description': 'Patients in this arm took 1mg of study drug, osilodrostat.'}, {'id': 'OG001', 'title': 'Osilodrostat 2mg', 'description': 'Patients in this arm took 2mg of study drug, osilodrostat.'}, {'id': 'OG002', 'title': 'Osilodrostat 3mg', 'description': 'Patients in this arm took 3mg of study drug, osilodrostat.'}, {'id': 'OG003', 'title': 'Osilodrostat 5mg', 'description': 'Patients in this arm took 5mg of study drug, osilodrostat.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.08', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '9.91', 'spread': '3.53', 'groupId': 'OG001'}, {'value': '24.0', 'spread': '21.00', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4, 2 hours post-dose', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Osilodrostat 1mg', 'description': 'Patients in this arm took 1mg of study drug, osilodrostat.'}, {'id': 'OG001', 'title': 'Osilodrostat 2mg', 'description': 'Patients in this arm took 2mg of study drug, osilodrostat.'}, {'id': 'OG002', 'title': 'Osilodrostat 3mg', 'description': 'Patients in this arm took 3mg of study drug, osilodrostat.'}, {'id': 'OG003', 'title': 'Osilodrostat 5mg', 'description': 'Patients in this arm took 5mg of study drug, osilodrostat.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.74', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '9.08', 'groupId': 'OG001'}, {'value': '31.7', 'spread': 'NA', 'comment': 'N/A : not enough participants to calculate the standard deviation', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 6, 2 hours post-dose', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Osilodrostat 1mg', 'description': 'Patients in this arm took 1mg of study drug, osilodrostat.'}, {'id': 'OG001', 'title': 'Osilodrostat 2mg', 'description': 'Patients in this arm took 2mg of study drug, osilodrostat.'}, {'id': 'OG002', 'title': 'Osilodrostat 3mg', 'description': 'Patients in this arm took 3mg of study drug, osilodrostat.'}, {'id': 'OG003', 'title': 'Osilodrostat 5mg', 'description': 'Patients in this arm took 5mg of study drug, osilodrostat.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.35', 'spread': '2.75', 'groupId': 'OG000'}, {'value': '13.9', 'spread': 'NA', 'comment': 'N/A : not enough participants to calculate the standard deviation', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8, 2 hours post-dose', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Osilodrostat 1mg', 'description': 'Patients in this arm took 1mg of study drug, osilodrostat.'}, {'id': 'OG001', 'title': 'Osilodrostat 2mg', 'description': 'Patients in this arm took 2mg of study drug, osilodrostat.'}, {'id': 'OG002', 'title': 'Osilodrostat 3mg', 'description': 'Patients in this arm took 3mg of study drug, osilodrostat.'}, {'id': 'OG003', 'title': 'Osilodrostat 5mg', 'description': 'Patients in this arm took 5mg of study drug, osilodrostat.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.73', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '11.3', 'spread': '4.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 10, 2 hours post-dose', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Osilodrostat 1mg', 'description': 'Patients in this arm took 1mg of study drug, osilodrostat.'}, {'id': 'OG001', 'title': 'Osilodrostat 2mg', 'description': 'Patients in this arm took 2mg of study drug, osilodrostat.'}, {'id': 'OG002', 'title': 'Osilodrostat 3mg', 'description': 'Patients in this arm took 3mg of study drug, osilodrostat.'}, {'id': 'OG003', 'title': 'Osilodrostat 5mg', 'description': 'Patients in this arm took 5mg of study drug, osilodrostat.'}], 'classes': [{'title': 'Week 12: 0.75 hour post-dose', 'categories': [{'measurements': [{'value': '0.382', 'spread': '0.171', 'groupId': 'OG000'}, {'value': '3.1', 'spread': 'NA', 'comment': 'N/A : not enough participants to calculate the standard deviation', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: 2 hours post-dose', 'categories': [{'measurements': [{'value': '4.62', 'spread': '2.51', 'groupId': 'OG000'}, {'value': '9.98', 'spread': 'NA', 'comment': 'N/A : not enough participants to calculate the standard deviation', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: 4 hours post-dose', 'categories': [{'measurements': [{'value': '3.58', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '6.57', 'spread': 'NA', 'comment': 'N/A : not enough participants to calculate the standard deviation', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Osilodrostat 1mg', 'description': 'Patients in this arm took 1mg of study drug, osilodrostat.'}, {'id': 'OG001', 'title': 'Osilodrostat 2mg', 'description': 'Patients in this arm took 2mg of study drug, osilodrostat.'}, {'id': 'OG002', 'title': 'Osilodrostat 3mg', 'description': 'Patients in this arm took 3mg of study drug, osilodrostat.'}, {'id': 'OG003', 'title': 'Osilodrostat 5mg', 'description': 'Patients in this arm took 5mg of study drug, osilodrostat.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.71', 'spread': '1.33', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16, 2 hours post-dose', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Osilodrostat 1mg', 'description': 'Patients in this arm took 1mg of study drug, osilodrostat.'}, {'id': 'OG001', 'title': 'Osilodrostat 2mg', 'description': 'Patients in this arm took 2mg of study drug, osilodrostat.'}, {'id': 'OG002', 'title': 'Osilodrostat 3mg', 'description': 'Patients in this arm took 3mg of study drug, osilodrostat.'}, {'id': 'OG003', 'title': 'Osilodrostat 5mg', 'description': 'Patients in this arm took 5mg of study drug, osilodrostat.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.794', 'spread': 'NA', 'comment': 'N/A : not enough participants to calculate the standard deviation', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 20, 2 hours post-dose', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Osilodrostat 1mg', 'description': 'Patients in this arm took 1mg of study drug, osilodrostat.'}, {'id': 'OG001', 'title': 'Osilodrostat 2mg', 'description': 'Patients in this arm took 2mg of study drug, osilodrostat.'}, {'id': 'OG002', 'title': 'Osilodrostat 3mg', 'description': 'Patients in this arm took 3mg of study drug, osilodrostat.'}, {'id': 'OG003', 'title': 'Osilodrostat 5mg', 'description': 'Patients in this arm took 5mg of study drug, osilodrostat.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.51', 'spread': '2.14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24, 2 hours post-dose', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Osilodrostat', 'description': 'Patients in this arm took the study drug, osilodrostat.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Completed Week-12 (Study Period I)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Discontinued at or Prior to Week-12', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Completed Week-12, Did Not Enter Per. II', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Completed Week-12, Entered Study Per. II', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Completed Week-48 (Study Period II)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Discontinued at or Prior to Week48', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': "Compl. Wk-48, Didn't Enter Opt. Ext. Per", 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'Compl. Wk-48, Entered Opt. Ext. Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Completed Optional Extension Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'Discontinued Study in Optional Ext. Per.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Subject/ Guardian decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Planned subjects: 10 subjects Actual enrolled: 9 subjects', 'preAssignmentDetails': 'Planned subjects: 10 subjects'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Osilodrostat', 'description': 'Patients in this arm took the study drug, osilodrostat.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.0', 'spread': '18.17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Japanese', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Type of disease', 'classes': [{'title': 'ACTH-Independent Macronodular Adrena;l Hyperplasia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Adrenal Adenoma', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Ectopic Corticotropin Syndrome', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-31', 'size': 1255024, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-24T21:14', 'hasProtocol': True}, {'date': '2018-06-22', 'size': 365357, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-24T21:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-23', 'studyFirstSubmitDate': '2015-06-08', 'resultsFirstSubmitDate': '2019-10-25', 'studyFirstSubmitQcDate': '2015-06-08', 'lastUpdatePostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-25', 'studyFirstPostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in the Mean Urine Free Cortisol (mUFC) at the Individual Level at Week 12', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Percent change from baseline in the mUFC at the individual patient level'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in the mUFC at Individual Patient Level at Week 24 (Day 169) and Week 48 (Day 337)', 'timeFrame': 'Baseline, Week 24 (day 169) and Week 48 (day 337)', 'description': 'Percent change from baseline in the mUFC at the individual patient level'}, {'measure': 'Absolute Change From Baseline in the mUFC at Week 12 (Day 85), Week 24 (Day 169) and Week 48 (Day 337)', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': 'Absolute change from baseline in the mUFC'}, {'measure': 'Percentage Change From Baseline in the mUFC at Week 12 (Day 85), Week 24 (Day 169) and Week 48 (Day 337)', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': 'Percent change from baseline in the mUFC'}, {'measure': 'Percentage of Participants With mUFC Response of Complete, Partial, and Overall Response', 'timeFrame': '12, 24 and 48 weeks', 'description': 'Complete response rate = percentage of participants who had mUFC≤ ULN; Partial response rate = Percentage of participants who had mUFC\\>ULN and at least 50% reduction from baseline in mUFC. Overall response rate = Percentage of participants who had mUFC ≤ ULN or at least 50% reduction from baseline.'}, {'measure': 'Absolute Change From Baseline in Morning Serum Cortisol at Individual Level', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': 'Absolute change from baseline in morning serum cortisol at the individual patient level'}, {'measure': 'Percentage Change From Baseline in Morning Serum Cortisol at Individual Level', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': 'Percentage change from baseline in morning serum cortisol at the individual patient level'}, {'measure': 'Absolute Change From Baseline in ACTH and Other Adrenal Steroid Hormones at Individual Level', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': 'Absolute change from baseline in several steroid hormones at individual levels: ACTH, Serum 11-deoxycorticosterone, Aldosterone, Estradiol'}, {'measure': 'Percentage Change From Baseline in ACTH and Other Adrenal Steroid Hormones at Individual Level', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': 'Percent change from baseline in several steroid hormones at individual levels: ACTH, Serum 11-deoxycorticosterone, Aldosterone, Estradiol'}, {'measure': 'Absolute Change From Baseline in Other Adrenal Steroid Hormones at Individual Levels', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': 'Absolute change from baseline in several steroid hormones at individual levels: Serum 11-deoxycortisol, Testosterone'}, {'measure': 'Percentage Change From Baseline in Other Adrenal Steroid Hormones at Individual Levels', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': 'Percent change from baseline in several steroid hormones at individual levels: Serum 11-deoxycortisol, Testosterone'}, {'measure': 'Absolute Change From Baseline in Cardiovascular-related Metabolic Parameter, Fasting Glucose, at Individual Level', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': "Absolute change in cardiovascular-related metabolic parameter fasting glucose, associated with Cushing's syndrome (CS)"}, {'measure': 'Percentage Change From Baseline in Cardiovascular-related Metabolic Parameter, Fasting Glucose, at Individual Level', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': "Percentasge change in cardiovascular-related metabolic parameter fasting glucose, associated with Cushing's syndrome (CS)"}, {'measure': 'Absolute Change From Baseline in Cardiovascular-related Metabolic Parameter, HbA1c, at Individual Level', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': "Absolute change in cardiovascular-related metabolic parameter HbA1c associated with Cushing's syndrome (CS)"}, {'measure': 'Percentage Change From Baseline in Cardiovascular-related Metabolic Parameter, HbA1c, at Individual Level', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': "Percentage change in cardiovascular-related metabolic parameter HbA1c associated with Cushing's syndrome (CS)"}, {'measure': 'Absolute Change From Baseline in Cardiovascular-related Metabolic Parameters, Cholesterol, HDL Cholesterol, LDL Cholesterol & Triglycerides, at Individual Level', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': "Absolute change in cardiovascular-related metabolic parameters: cholesterol, HDL cholesterol, LDL cholesterol \\& triglycerides, associated with Cushing's syndrome (CS)"}, {'measure': 'Percentage Change From Baseline in Cardiovascular-related Metabolic Parameters, Cholesterol, HDL Cholesterol, LDL Cholesterol & Triglycerides, at Individual Level', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': "Percent change in cardiovascular-related metabolic parameters: cholesterol, HDL cholesterol, LDL cholesterol \\& triglycerides, associated with Cushing's syndrome (CS)"}, {'measure': 'Absolute Change From Baseline in Cardiovascular-related Metabolic Parameter, BMI, at Individual Level', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': "Absolute change in cardiovascular-related metabolic parameter: BMI, associated with Cushing's syndrome (CS)"}, {'measure': 'Percentage Change From Baseline in Cardiovascular-related Metabolic Parameter, BMI, at Individual Level', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': "Percent change in cardiovascular-related metabolic parameter: BMI, associated with Cushing's syndrome (CS)"}, {'measure': 'Absolute Change From Baseline in Cardiovascular-related Metabolic Parameter, Waist Circumference, at Individual Level', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': "Absolute change in cardiovascular-related metabolic parameter: Waist circumference, associated with Cushing's syndrome (CS)"}, {'measure': 'Percentage Change From Baseline in Cardiovascular-related Metabolic Parameter, Waist Circumference, at Individual Level', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': "Percent change in cardiovascular-related metabolic parameter: Waist circumference, associated with Cushing's syndrome (CS)"}, {'measure': 'Absolute Change From Baseline in Cardiovascular-related Metabolic Parameter, Sitting Blood Pressure (BP) at Individual Level', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': "Absolute change in cardiovascular-related metabolic parameter: sitting systolic BP \\& sitting diastolic BP, associated with Cushing's syndrome (CS)"}, {'measure': 'Percentage Change From Baseline in Cardiovascular-related Metabolic Parameter, Sitting Blood Pressure (BP) at Individual Level', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': "Percentage change in cardiovascular-related metabolic parameter: sitting systolic BP \\& sitting diastolic BP, associated with Cushing's syndrome"}, {'measure': 'Total Scores in Patient-Reported Outcomes Health-related Quality of Life (QoL) as Assessed by Cushing QoL at Individual Level', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': "The Cushing's Disease Health-Related Quality of Life Questionnaire (Cushing QoL) (version 1.0) was developed to evaluate quality of life in patients with Cushing's syndrome (Webb et al 2008). The Cushing QoL is comprised of 12 items that capture patient responses on seven concepts: daily activities, healing and pain, mood and self-confidence, social concerns, physical appearance, memory and concern about the future. Each questionnaire of the Cushing QOL has a scale of 1-5 where '1' corresponding to 'Always' or 'Very much' and '5' to 'Never' or 'Not at all'. The lower the score, the greater the impact on HRQoL. The score is the sum of all the item response and can range from 12 (worst) to 60 points (best)."}, {'measure': 'Total Scores in Patient-Reported Outcomes Health-related Quality of Life (QoL) as Assessed by Beck Depression Inventory II (BDI-ll) Depression Score at Individual Level', 'timeFrame': 'Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)', 'description': 'The Beck Depression Inventory II (BDI-II) is a patient reported instrument that consists of 21 items designed to assess the intensity of depression in clinical \\& normal patients in the preceding two weeks. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. Each of 21 items corresponds to a symptom of depression and the sum of total score will be calculated where each item has a four-point scale ranging from 0 to 3, leading to a total score from zero to 63.'}, {'measure': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 0', 'timeFrame': 'Week 0', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.'}, {'measure': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 1', 'timeFrame': 'Week 1, 2 hours post-dose', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.'}, {'measure': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 2', 'timeFrame': 'Week 2', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.'}, {'measure': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 3', 'timeFrame': 'Week 3, 2 hours post-dose', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.'}, {'measure': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 4', 'timeFrame': 'Week 4, 2 hours post-dose', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.'}, {'measure': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 6', 'timeFrame': 'Week 6, 2 hours post-dose', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.'}, {'measure': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 8', 'timeFrame': 'Week 8, 2 hours post-dose', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.'}, {'measure': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 10', 'timeFrame': 'Week 10, 2 hours post-dose', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.'}, {'measure': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 12', 'timeFrame': 'Week 12', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.'}, {'measure': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 16', 'timeFrame': 'Week 16, 2 hours post-dose', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.'}, {'measure': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 20', 'timeFrame': 'Week 20, 2 hours post-dose', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.'}, {'measure': 'Plasma Concentrations of Osilodrostat (LCI699) at Week 24', 'timeFrame': 'Week 24, 2 hours post-dose', 'description': 'Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Cushing's syndrome", 'osilodrostat', 'LCI699', 'ectopic corticotropin syndrome', 'adrenal adenoma', 'adrenal carcinoma', 'ACTH-Independent Macronodular Adrenal Hyperplasia', 'AIMAH', 'Primary Pigmented Nodular Adrenal Dysplasia', 'PPNAD'], 'conditions': ["Cushing's Syndrome", 'Ectopic Corticotropin Syndrome', 'Adrenal Adenoma', 'Adrenal Carcinoma', 'AIMAH', 'PPNAD']}, 'descriptionModule': {'briefSummary': "The study aim was to investigate the efficacy and safety of Osilodrostat in patients with Cushing's syndrome due to causes other than Cushing's disease in Japan.", 'detailedDescription': 'This was a Phase II, single arm, open-label, dose titration, multi-center study which consisted of two distinct Study Periods plus an optional extension period in non-CD patients with CS. The 3 Study Periods (two distinct Study Periods plus an optional extension period) were as follows:\n\nStudy Period I \\[Week 0 (Day 1) to Week-12\\]: Study Period I was the dose titration period to achieve a stable therapeutic dose and to assess the efficacy and safety of osilodrostat.\n\nThe dosing regimen of osilodrostat in this study was titrated according to the following escalation sequence: osilodrostat 2 mg bid, 5 mg bid, 10 mg bid, 20 mg bid, and 30 mg bid. Dose adjustments were based on the serum cortisol values measured by the local lab at each site. Osilodrostat titration was done weekly for the initial 4-weeks, up to a maximum dose of 10 mg bid.\n\nThe mean of three 24-hour UFC (mUFC) values were measured to evaluate the efficacy in this period.\n\nStudy Period II (After Week-12 to Week-48): Study Period II was the period to assess the sustainability of efficacy and long term safety.\n\nDuring Study Period II, only patients who tolerated and agreed to continue osilodrostat treatment continued on the study. The patient was administered with the stable therapeutic dose which was achieved in the Study Period I.\n\nOptional extension period (After Week-48): Patients who continued to receive clinical benefit, as assessed by the study Investigator and who wished to enter the extension period were reconsented at Week-48. Patients who entered the extension period continued to be treated with the study drug without interruption to be assessed for efficacy and safety. Patients who continued to benefit from study treatment as assessed by the study investigator and who completed Week-72 were offered to participate in a separate long-term safety follow-up study. The optional extension period ended after all patients had completed Week-72 or had discontinued early.\n\nPost-treatment Follow-up: All patients had 30 days safety follow-up after the last dose of study treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with confirmed Cushing's syndrome \\[i.e. ectopic corticotropin syndrome, adrenal adenoma, adrenal carcinoma, ACTH-Independent Macronodular Adrenal Hyperplasia (AIMAH), or Primary Pigmented Nodular Adrenal Dysplasia (PPNAD)\\]\n* For patients on medical treatment for hypercortisolism due to Cushing's syndrome, the washout periods had to be completed prior to baseline efficacy assessments\n\nExclusion Criteria:\n\n* Patients with Cushing's disease\n* History of hypersensitivity to osilodrostat or to drugs of similar chemical classes\n* History of malignancy of any organ system, treated or untreated, within the past 5 years\n* Patients receiving treatment for within 4 weeks or ≤5 x half-life of the agent (whichever is longer) before first dose of osilodrostat\n* Patients with risk factors for QTc prolongation or Torsade de Pointes"}, 'identificationModule': {'nctId': 'NCT02468193', 'briefTitle': "Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome", 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': "A Phase II, Open-label, Dose Titration, Multi-center Study to Assess the Safety/Tolerability and Efficacy of Osilodrostat in Patients With All Types of Endogenous Cushing's Syndrome Except Cushing's Disease", 'orgStudyIdInfo': {'id': 'CLCI699C1201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Osilodrostat', 'description': 'Patients in this arm took the study drug, osilodrostat.', 'interventionNames': ['Drug: Osilodrostat']}], 'interventions': [{'name': 'Osilodrostat', 'type': 'DRUG', 'otherNames': ['LCI699'], 'description': 'Osirodrostat 1mg, 5mg \\& 10mg in the form of film-coated tablets was used for oral administration.', 'armGroupLabels': ['Osilodrostat']}]}, 'contactsLocationsModule': {'locations': [{'zip': '960 1295', 'city': 'Fukushima', 'state': 'Fukushima', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'zip': '245-8575', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '980 8574', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '260 8677', 'city': 'Chiba', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'url': 'https://www.clinicalstudydatarequest.com', 'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data is currently available according to the process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}