Viewing Study NCT01360866

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Ignite Creation Date: 2025-12-24 @ 4:08 PM
Ignite Modification Date: 2025-12-25 @ 4:50 PM
Study NCT ID: NCT01360866
Status: COMPLETED
Last Update Posted: 2018-09-17
First Post: 2011-05-24
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Czechia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089983', 'term': 'Escitalopram'}, {'id': 'D005473', 'term': 'Fluoxetine'}, {'id': 'D017374', 'term': 'Paroxetine'}, {'id': 'D020280', 'term': 'Sertraline'}, {'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}, {'id': 'D000069470', 'term': 'Venlafaxine Hydrochloride'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltransparency@otsuka-us.com', 'phone': '609 524 6788', 'title': 'Global Clinical Development', 'organization': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'certainAgreement': {'otherDetails': 'Until the information herein is released by Otsuka to the public domain, the contents of this document are Otsuka confidential information and should not be duplicated or re-distributed without prior written consent of Otsuka.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.', 'description': 'An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related.\n\nAn AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event', 'eventGroups': [{'id': 'EG000', 'title': 'Prior Placebo', 'description': 'Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.', 'otherNumAtRisk': 516, 'deathsNumAtRisk': 516, 'otherNumAffected': 296, 'seriousNumAtRisk': 516, 'deathsNumAffected': 2, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Prior Brexpiprazole', 'description': 'Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.', 'otherNumAtRisk': 706, 'deathsNumAtRisk': 706, 'otherNumAffected': 323, 'seriousNumAtRisk': 706, 'deathsNumAffected': 2, 'seriousNumAffected': 23}, {'id': 'EG002', 'title': 'Prior ADT', 'description': 'Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.', 'otherNumAtRisk': 1640, 'deathsNumAtRisk': 1640, 'otherNumAffected': 787, 'seriousNumAtRisk': 1640, 'deathsNumAffected': 0, 'seriousNumAffected': 33}, {'id': 'EG003', 'title': 'Prior Seroquel', 'description': 'Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 33, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 61}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fatigue', 'notes': 'General Disorders and Administration Site Conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 88}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 98}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Weight Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 118}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 100}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 296}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Increased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 117}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 99}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 105}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 60}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 130}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 76}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 108}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Iron Deficiency Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aortic Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ventricular Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blepharospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Retinal Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': "Crohn's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastric Ulcer Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Drug Withdrawal Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hepatitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Kidney Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intentional Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Patella Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Electrocardiogram Qt Prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Type 2 Diabetes Mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lumbar Spinal Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Spinal Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intraductal Proliferative Breast Lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ovarian Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pancreatic Neuroendocrine Tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rectal Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Renal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Extrapyramidal Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lumbar Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ruptured Cerebral Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Completed Suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Depressive Symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intentional Self-Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Major Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Renal Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pelvic Adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chronic Obstructive Pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 706, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1640, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adverse Events (AEs) - All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}, {'value': '706', 'groupId': 'OG001'}, {'value': '1640', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo', 'description': 'Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}, {'id': 'OG001', 'title': 'Prior Brexpiprazole', 'description': 'Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}, {'id': 'OG002', 'title': 'Prior ADT', 'description': 'Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}, {'id': 'OG003', 'title': 'Prior Seroquel', 'description': 'Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}], 'classes': [{'title': 'Participants with adverse events', 'categories': [{'measurements': [{'value': '400', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}, {'value': '1165', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}]}, {'title': 'Participants with treatment emergent AE (TEAE)', 'categories': [{'measurements': [{'value': '399', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}, {'value': '1163', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}]}, {'title': 'Participants with serious TEAE', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Participants with severe TEAE', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Partcipants discontinued due to AEs', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From screening to week 52/early termination', 'description': 'To assess the frequency and severity of AEs as the variables of safety and tolerability of brexpiprazole.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '698', 'groupId': 'OG001'}, {'value': '1630', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo', 'description': 'Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}, {'id': 'OG001', 'title': 'Prior Brexpiprazole', 'description': 'Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}, {'id': 'OG002', 'title': 'Prior ADT', 'description': 'Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}, {'id': 'OG003', 'title': 'Prior Seroquel', 'description': 'Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.77', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '-0.63', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '-0.48', 'spread': '1.04', 'groupId': 'OG002'}, {'value': '-0.93', 'spread': '0.85', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From screening to week 52/early termination', 'description': 'The severity of illness for each participant was rated using the CGI-S . On the basis of the investigator answer to the question: "Considering your total clinical experience with this particular population, how mentally ill was the participant at that time?" Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '505', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}, {'value': '1606', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo', 'description': 'Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}, {'id': 'OG001', 'title': 'Prior Brexpiprazole', 'description': 'Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}, {'id': 'OG002', 'title': 'Prior ADT', 'description': 'Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}, {'id': 'OG003', 'title': 'Prior Seroquel', 'description': 'Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.60', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '2.63', 'spread': '1.34', 'groupId': 'OG001'}, {'value': '2.63', 'spread': '1.39', 'groupId': 'OG002'}, {'value': '2.40', 'spread': '1.17', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From screening to week 52/early termination', 'description': "The efficacy of trial treatment was rated for each participant using the CGI-I. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. All responses were compared to the participant's condition at screening. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S.'}, {'type': 'SECONDARY', 'title': 'Summary of Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '457', 'groupId': 'OG001'}, {'value': '1165', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo', 'description': 'Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}, {'id': 'OG001', 'title': 'Prior Brexpiprazole', 'description': 'Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}, {'id': 'OG002', 'title': 'Prior ADT', 'description': 'Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}, {'id': 'OG003', 'title': 'Prior Seroquel', 'description': 'Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.80', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '2.60', 'groupId': 'OG001'}, {'value': '-0.40', 'spread': '2.30', 'groupId': 'OG002'}, {'value': '-1.00', 'spread': '1.70', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From screening to week 52/early termination', 'description': "The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on regular life responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains with scores from 0 = not at all, to 10 = extremely.\n\nScores of 5 and above were associated with significant functional impairment.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Inventory of Depressive Symptomatology - Self Report (IDS-SR) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '491', 'groupId': 'OG000'}, {'value': '664', 'groupId': 'OG001'}, {'value': '1556', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo', 'description': 'Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}, {'id': 'OG001', 'title': 'Prior Brexpiprazole', 'description': 'Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}, {'id': 'OG002', 'title': 'Prior ADT', 'description': 'Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}, {'id': 'OG003', 'title': 'Prior Seroquel', 'description': 'Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.25', 'spread': '12.21', 'groupId': 'OG000'}, {'value': '-4.76', 'spread': '11.79', 'groupId': 'OG001'}, {'value': '-3.94', 'spread': '10.57', 'groupId': 'OG002'}, {'value': '-7.44', 'spread': '8.89', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From screening to week 52/early termination', 'description': 'The IDS-SR was a 30-item self-report measure used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of MDD. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the "best" rating and 3 being the "worst" rating. The IDS-SR Total Score is the sum of ratings of 28 item scores. The possible IDS-SR Total Score ranges from 0 (best) to 84 (worst).\n\nUnder item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. If the number of items recorded is at least 23 and at most 27, the IDS-SR Total Score will be the mean of the recorded items multiplied by 28 and then rounded to the first decimal place.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prior Placebo', 'description': 'Participants who received placebo with antidepressant therapy \\[ADT\\] in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}, {'id': 'FG001', 'title': 'Prior Brexpiprazole', 'description': 'Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}, {'id': 'FG002', 'title': 'Prior ADT', 'description': 'Participants who received only ADT in previous double blind phase 3 studies and were not randomized, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}, {'id': 'FG003', 'title': 'Prior Seroquel', 'description': 'Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '516'}, {'groupId': 'FG001', 'numSubjects': '707'}, {'groupId': 'FG002', 'numSubjects': '1645'}, {'groupId': 'FG003', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '295'}, {'groupId': 'FG001', 'numSubjects': '420'}, {'groupId': 'FG002', 'numSubjects': '1126'}, {'groupId': 'FG003', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '221'}, {'groupId': 'FG001', 'numSubjects': '287'}, {'groupId': 'FG002', 'numSubjects': '519'}, {'groupId': 'FG003', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '134'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Paticipant met withdrawal criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawn by Investigator', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by participant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '168'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '61'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'This trial was conducted in 2944 participants at 188 sites in 11 countries: Canada, France, Germany, Hungary, Poland, Romania, Russian Federation, Serbia, Slovakia, Ukraine, and United States (US).', 'preAssignmentDetails': 'The study population consisted of eligible participants who completed one of the double-blind, phase 3 brexpiprazole major depressive disorder (MDD) trials and who, could potentially benefit from adjunctive treatment with oral brexpiprazole for MDD.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'BG000'}, {'value': '707', 'groupId': 'BG001'}, {'value': '1645', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}, {'value': '2944', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Prior Placebo', 'description': 'Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}, {'id': 'BG001', 'title': 'Prior Brexpiprazole', 'description': 'Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}, {'id': 'BG002', 'title': 'Prior ADT', 'description': 'Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}, {'id': 'BG003', 'title': 'Prior Seroquel', 'description': 'Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.0', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '45.0', 'spread': '11.0', 'groupId': 'BG001'}, {'value': '44.0', 'spread': '12.0', 'groupId': 'BG002'}, {'value': '44.0', 'spread': '11.0', 'groupId': 'BG003'}, {'value': '45.0', 'spread': '12.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '367', 'groupId': 'BG000'}, {'value': '479', 'groupId': 'BG001'}, {'value': '1108', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '2005', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '228', 'groupId': 'BG001'}, {'value': '537', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '939', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '452', 'groupId': 'BG000'}, {'value': '609', 'groupId': 'BG001'}, {'value': '1459', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '2588', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '288', 'groupId': 'BG004'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'comprised of all participants who signed an informed consent form (ICF) for the trial.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-06-13', 'size': 1369255, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-05-25T11:26', 'hasProtocol': True}, {'date': '2017-05-25', 'size': 2403656, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-05-25T11:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2944}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-14', 'studyFirstSubmitDate': '2011-05-24', 'resultsFirstSubmitDate': '2018-05-25', 'studyFirstSubmitQcDate': '2011-05-25', 'lastUpdatePostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-14', 'studyFirstPostDateStruct': {'date': '2011-05-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events (AEs) - All Participants', 'timeFrame': 'From screening to week 52/early termination', 'description': 'To assess the frequency and severity of AEs as the variables of safety and tolerability of brexpiprazole.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness Score', 'timeFrame': 'From screening to week 52/early termination', 'description': 'The severity of illness for each participant was rated using the CGI-S . On the basis of the investigator answer to the question: "Considering your total clinical experience with this particular population, how mentally ill was the participant at that time?" Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.'}, {'measure': 'Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score', 'timeFrame': 'From screening to week 52/early termination', 'description': "The efficacy of trial treatment was rated for each participant using the CGI-I. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. All responses were compared to the participant's condition at screening. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse."}, {'measure': 'Summary of Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score', 'timeFrame': 'From screening to week 52/early termination', 'description': "The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on regular life responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains with scores from 0 = not at all, to 10 = extremely.\n\nScores of 5 and above were associated with significant functional impairment."}, {'measure': 'Change From Baseline in the Inventory of Depressive Symptomatology - Self Report (IDS-SR) Total Score', 'timeFrame': 'From screening to week 52/early termination', 'description': 'The IDS-SR was a 30-item self-report measure used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of MDD. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the "best" rating and 3 being the "worst" rating. The IDS-SR Total Score is the sum of ratings of 28 item scores. The possible IDS-SR Total Score ranges from 0 (best) to 84 (worst).\n\nUnder item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. If the number of items recorded is at least 23 and at most 27, the IDS-SR Total Score will be the mean of the recorded items multiplied by 28 and then rounded to the first decimal place.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['OPC-34712', 'brexpiprazole', 'Major Depressive Disorder', 'Adjunctive Treatment'], 'conditions': ['Depressive Disorder', 'Depression', 'Depressive Disorder, Major', 'Mood Disorders', 'Mental Disorders']}, 'referencesModule': {'references': [{'pmid': '37656180', 'type': 'DERIVED', 'citation': 'Newcomer JW, Meehan SR, Chen D, Brubaker M, Weiss C. Changes in Metabolic Parameters and Body Weight in Patients With Prediabetes Treated With Adjunctive Brexpiprazole for Major Depressive Disorder: Pooled Analysis of Short- and Long-Term Clinical Studies. J Clin Psychiatry. 2023 Aug 28;84(5):23m14786. doi: 10.4088/JCP.23m14786.'}, {'pmid': '31577867', 'type': 'DERIVED', 'citation': 'Newcomer JW, Eriksson H, Zhang P, Meehan SR, Weiss C. Changes in Metabolic Parameters and Body Weight in Patients With Major Depressive Disorder Treated With Adjunctive Brexpiprazole: Pooled Analysis of Phase 3 Clinical Studies. J Clin Psychiatry. 2019 Oct 1;80(6):18m12680. doi: 10.4088/JCP.18m12680.'}]}, 'descriptionModule': {'briefSummary': 'To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and Female outpatients 18-65 years of age\n\nEligible subjects from Trials 331-10-227, 331-10-228 or 331-12-282:\n\n* Subjects who completed participation in the Double-blind Randomization Phase (i.e. Week 14 visit) in Trial 331-10-227, Trial 331-10-228, or Trial 331-12-282 or\n* Subjects who met criteria for a response, but did not meet criteria for remission at Week 14 of either trial\n\nEligible subjects from other Phase 3, Double-blind, Brexpiprazole MDD trials:\n\n• Subjects who completed the last scheduled visit of the prior Double-blind Randomized Phase 3 trial.\n\nExclusion Criteria:\n\n* Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving OPC-34712.\n* Subjects with a major protocol violation during the course of their participation in the Double-blind Randomization Phase'}, 'identificationModule': {'nctId': 'NCT01360866', 'acronym': 'Orion', 'briefTitle': 'Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'officialTitle': 'A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder, the Orion Trial', 'orgStudyIdInfo': {'id': '331-10-238'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OPC-34712 (Brexpiprazole) and Escitalopram', 'description': 'OPC-34712: Oral tablet; 0.5 to 3 mg/day Escitalopram: Oral tablet; 10 or 20 mg/day', 'interventionNames': ['Drug: OPC-34712', 'Drug: Escitalopram']}, {'type': 'EXPERIMENTAL', 'label': 'OPC-34712 and Fluoxetine', 'description': 'OPC-34712: Oral tablet; 0.5 to 3 mg/day Fluoxetine: Oral capsules; 20 or 40 mg/day', 'interventionNames': ['Drug: OPC-34712', 'Drug: Fluoxetine']}, {'type': 'EXPERIMENTAL', 'label': 'OPC-34712 and Paroxetine CR', 'description': 'OPC-34712: Oral tablet; 0.5 to 3 mg/day Paroxetine CR: Oral controlled-release tablets; 37.5 or 50 mg/day', 'interventionNames': ['Drug: OPC-34712', 'Drug: Paroxetine CR']}, {'type': 'EXPERIMENTAL', 'label': 'OPC-34712 and Sertraline', 'description': 'OPC-34712: Oral tablet; 0.5 to 3 mg/day Sertraline: Oral tablets; 100, 150, or 200 mg/day', 'interventionNames': ['Drug: OPC-34712', 'Drug: Sertraline']}, {'type': 'EXPERIMENTAL', 'label': 'OPC-34712 and Duloxetine', 'description': 'OPC-34712: Oral tablet; 0.5 to 3 mg/day Duloxetine: Oral delayed-release capsules; 40 or 60 mg/day', 'interventionNames': ['Drug: OPC-34712', 'Drug: Duloxetine']}, {'type': 'EXPERIMENTAL', 'label': 'OPC-34712 and Venlafaxine XR', 'description': 'OPC-34712: Oral tablet; 0.5 to 3 mg/day Venlafaxine XR: Oral extended-release capsules; 75, 150, or 225 mg/day', 'interventionNames': ['Drug: OPC-34712', 'Drug: Venlafaxine XR']}], 'interventions': [{'name': 'OPC-34712', 'type': 'DRUG', 'description': 'Tablet', 'armGroupLabels': ['OPC-34712 (Brexpiprazole) and Escitalopram', 'OPC-34712 and Duloxetine', 'OPC-34712 and Fluoxetine', 'OPC-34712 and Paroxetine CR', 'OPC-34712 and Sertraline', 'OPC-34712 and Venlafaxine XR']}, {'name': 'Escitalopram', 'type': 'DRUG', 'otherNames': ['Lexapro'], 'description': 'Tablet', 'armGroupLabels': ['OPC-34712 (Brexpiprazole) and Escitalopram']}, {'name': 'Fluoxetine', 'type': 'DRUG', 'otherNames': ['Prozac'], 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