Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-02-25 @ 11:06 PM
Study NCT ID:
NCT01438060
Status:
COMPLETED
Last Update Posted:
2013-12-02
First Post:
2011-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068180', 'term': 'Aripiprazole'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'title': 'BMS Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Limitations of the study, such as early termination leading to small numbers of subjects analyzed and technical problems with measurement leading to unreliable or uninterpretable data'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '1 Double Blind Aripiprazole', 'otherNumAtRisk': 105, 'otherNumAffected': 31, 'seriousNumAtRisk': 105, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': '2 Double Blind Placebo', 'otherNumAtRisk': 102, 'otherNumAffected': 27, 'seriousNumAtRisk': 102, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': '3 Ext - Aripiprazole', 'otherNumAtRisk': 161, 'otherNumAffected': 101, 'seriousNumAtRisk': 161, 'seriousNumAffected': 84}], 'otherEvents': [{'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SOMNOLENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 30}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 18}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 14}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'APATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 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'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ECZEMA VESICULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ESCHERICHIA SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'FEMUR FRACTURE', 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'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SALIVARY HYPERSECRETION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'URINARY RETENTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BRONCHOPNEUMOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CIRCULATORY COLLAPSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PERIPHERAL ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PROSTATE CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PYELONEPHRITIS', 'stats': 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CARDIAC ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CARDIAC FAILURE ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CARDIOPULMONARY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HUMERUS FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Injury, 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'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'RENAL FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ATRIAL FLUTTER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 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{'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'FEMORAL NECK FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HAND FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PSYCHOTIC DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 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'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SUDDEN CARDIAC DEATH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'AGGRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CATARACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MALNUTRITION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'RESPIRATORY ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'VARICOSE VEIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ABDOMINAL 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'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CHILLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DEMENTIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HIP FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LOSS OF CONSCIOUSNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LUNG INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': "MENDELSON'S SYNDROME", 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MYOCARDIAL ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PANCREATIC CARCINOMA METASTATIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PELVIC FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'RESPIRATORY DISTRESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SUDDEN DEATH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'TRANSIENT ISCHAEMIC ATTACK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 10 in Acute Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Baseline (Day 0)', 'categories': [{'measurements': [{'value': '12.12', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '12.29', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'Mean Change from Baseline at Week 10', 'categories': [{'measurements': [{'value': '-5.52', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '-6.55', 'spread': '0.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.802', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-1.15', 'ciUpperLimit': '1.49', 'pValueComment': 'Baseline data was evaluated by analysis of variance (ANOVA) with treatment and study center as main effects.', 'estimateComment': 'Model based estimate.', 'groupDescription': 'Analysis at Baseline (Day 0)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.169', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.02', 'ciLowerLimit': '-2.49', 'ciUpperLimit': '0.44', 'pValueComment': 'ANCOVA model for LOCF data set included the baseline measure as covariate and the study center and treatment as main effects.', 'estimateComment': 'Model based estimate', 'groupDescription': 'Analysis at Week 10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Week 10', 'description': 'The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Last Observation Carried forward (LOCF) data set, efficacy sample.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Baseline (Day 0)', 'categories': [{'measurements': [{'value': '12.12', 'spread': '0.60', 'groupId': 'OG000', 'lowerLimit': '10.95', 'upperLimit': '13.30'}, {'value': '12.29', 'spread': '0.59', 'groupId': 'OG001', 'lowerLimit': '11.12', 'upperLimit': '13.46'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '-3.33', 'spread': '0.53', 'groupId': 'OG000', 'lowerLimit': '-4.37', 'upperLimit': '-2.28'}, {'value': '-2.26', 'spread': '0.52', 'groupId': 'OG001', 'lowerLimit': '-3.29', 'upperLimit': '-1.22'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-3.96', 'spread': '0.67', 'groupId': 'OG000', 'lowerLimit': '-5.27', 'upperLimit': '-2.65'}, {'value': '-3.81', 'spread': '0.66', 'groupId': 'OG001', 'lowerLimit': '-5.11', 'upperLimit': '-2.50'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-4.54', 'spread': '0.64', 'groupId': 'OG000', 'lowerLimit': '-5.80', 'upperLimit': '-3.28'}, {'value': '-4.86', 'spread': '0.64', 'groupId': 'OG001', 'lowerLimit': '-6.12', 'upperLimit': '-3.61'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-5.38', 'spread': '0.61', 'groupId': 'OG000', 'lowerLimit': '-6.59', 'upperLimit': '-4.18'}, {'value': '-5.66', 'spread': '0.61', 'groupId': 'OG001', 'lowerLimit': '-6.86', 'upperLimit': '-4.47'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-4.87', 'spread': '0.64', 'groupId': 'OG000', 'lowerLimit': '-6.13', 'upperLimit': '-3.61'}, {'value': '-6.00', 'spread': '0.63', 'groupId': 'OG001', 'lowerLimit': '-7.25', 'upperLimit': '-4.75'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-5.04', 'spread': '0.69', 'groupId': 'OG000', 'lowerLimit': '-6.40', 'upperLimit': '-3.69'}, {'value': '-6.01', 'spread': '0.68', 'groupId': 'OG001', 'lowerLimit': '-7.36', 'upperLimit': '-4.67'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, and 8', 'description': 'The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.', 'unitOfMeasure': 'Units on Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF data set, efficacy sample.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in NPI Total Score in Acute Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Baseline (Day 0)', 'categories': [{'measurements': [{'value': '40.08', 'spread': '1.88', 'groupId': 'OG000', 'lowerLimit': '36.38', 'upperLimit': '43.78'}, {'value': '39.82', 'spread': '1.86', 'groupId': 'OG001', 'lowerLimit': '36.14', 'upperLimit': '43.49'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '-6.26', 'spread': '1.58', 'groupId': 'OG000', 'lowerLimit': '-9.39', 'upperLimit': '-3.13'}, {'value': '-4.13', 'spread': '1.57', 'groupId': 'OG001', 'lowerLimit': '-7.23', 'upperLimit': '-1.03'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-9.98', 'spread': '1.86', 'groupId': 'OG000', 'lowerLimit': '-13.65', 'upperLimit': '-6.32'}, {'value': '-8.40', 'spread': '1.84', 'groupId': 'OG001', 'lowerLimit': '-12.04', 'upperLimit': '-4.77'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-10.85', 'spread': '2.13', 'groupId': 'OG000', 'lowerLimit': '-15.04', 'upperLimit': '-6.65'}, {'value': '-8.61', 'spread': '2.11', 'groupId': 'OG001', 'lowerLimit': '-12.77', 'upperLimit': '-4.45'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-11.81', 'spread': '1.87', 'groupId': 'OG000', 'lowerLimit': '-15.50', 'upperLimit': '-8.12'}, {'value': '-11.74', 'spread': '1.86', 'groupId': 'OG001', 'lowerLimit': '-15.40', 'upperLimit': '-8.08'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-10.47', 'spread': '2.09', 'groupId': 'OG000', 'lowerLimit': '-14.59', 'upperLimit': '-6.35'}, {'value': '-11.61', 'spread': '2.07', 'groupId': 'OG001', 'lowerLimit': '-15.69', 'upperLimit': '-7.52'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-9.68', 'spread': '2.32', 'groupId': 'OG000', 'lowerLimit': '-14.26', 'upperLimit': '-5.09'}, {'value': '-10.71', 'spread': '2.30', 'groupId': 'OG001', 'lowerLimit': '-15.26', 'upperLimit': '-6.17'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-9.75', 'spread': '2.35', 'groupId': 'OG000', 'lowerLimit': '-14.40', 'upperLimit': '-5.11'}, {'value': '-11.20', 'spread': '2.33', 'groupId': 'OG001', 'lowerLimit': '-15.80', 'upperLimit': '-6.59'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Total Score is calculated by adding the Individual Item Scores for all 12 domains, to yield a possible NPI Total Score of 0 to 144. Lower score=less severity. A negative change score from baseline indicates improvement.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF data set, efficacy sample.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Participants Who Demonstrated a ≥ 50% Decrease From Baseline to Endpoint in the NPI Psychosis Subscale Score in Acute Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.391', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.47', 'ciUpperLimit': '1.35', 'groupDescription': 'Analysis at Week 1', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Cochran-Mantel-Haenszel (CMH) test with controlling for treatment and study center', 'testedNonInferiority': False}, {'pValue': '0.766', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.31', 'groupDescription': 'Analysis at Week 2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'CMH test with controlling for treatment and study center', 'testedNonInferiority': False}, {'pValue': '0.967', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.32', 'pValueComment': 'CMH test with controlling for treatment and study center', 'groupDescription': 'Analysis at Week 3', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.505', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.19', 'pValueComment': 'CMH test with controlling for treatment and study center', 'groupDescription': 'Analysis at Week 4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.590', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.36', 'pValueComment': 'CMH test with controlling for treatment and study center', 'groupDescription': 'Analysis at Week 6', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.374', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.37', 'pValueComment': 'CMH test with controlling for treatment and study center', 'groupDescription': 'Analysis at Week 8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.175', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.41', 'pValueComment': 'CMH test with controlling for treatment and study center', 'groupDescription': 'Analysis at Week 10', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF data set, efficacy sample.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Participants Who Demonstrated a ≥ 50% Decrease From Baseline in the Total NPI Score in Acute Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.753', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.41', 'ciUpperLimit': '1.92', 'pValueComment': 'CMH test with controlling for treatment and study center', 'groupDescription': 'Analysis at week 1', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.600', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.32', 'pValueComment': 'CMH test with controlling for treatment and study center', 'groupDescription': 'Analysis at week 2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.673', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.31', 'pValueComment': 'CMH test with controlling for treatment and study center', 'groupDescription': 'Analysis at week 3', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.255', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.14', 'pValueComment': 'CMH test with controlling for treatment and study center', 'groupDescription': 'Analysis at week 4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.958', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.33', 'pValueComment': 'CMH test with controlling for treatment and study center', 'groupDescription': 'Analysis at week 6', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.525', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.19', 'pValueComment': 'CMH test with controlling for treatment and study center', 'groupDescription': 'Analysis at week 8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.602', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.40', 'pValueComment': 'CMH test with controlling for treatment and study center', 'groupDescription': 'Analysis at week 10', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Total Score is calculated by adding the Individual Item Scores for all 12 domains, to yield a possible NPI Total Score of 0 to 144. Lower score=less severity. A negative change score from baseline indicates improvement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF data set, efficacy sample.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in NPI Psychosis Subscale Caregiver Distress Score in Acute Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Baseline (Day 0)', 'categories': [{'measurements': [{'value': '4.80', 'spread': '0.25', 'groupId': 'OG000', 'lowerLimit': '4.30', 'upperLimit': '5.29'}, {'value': '4.70', 'spread': '0.25', 'groupId': 'OG001', 'lowerLimit': '4.21', 'upperLimit': '5.19'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '-0.80', 'spread': '0.21', 'groupId': 'OG000', 'lowerLimit': '-1.21', 'upperLimit': '-0.38'}, {'value': '-0.64', 'spread': '0.21', 'groupId': 'OG001', 'lowerLimit': '-1.05', 'upperLimit': '-0.24'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.84', 'spread': '0.23', 'groupId': 'OG000', 'lowerLimit': '-1.30', 'upperLimit': '-0.38'}, {'value': '-0.78', 'spread': '0.23', 'groupId': 'OG001', 'lowerLimit': '-1.24', 'upperLimit': '-0.33'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-1.15', 'spread': '0.24', 'groupId': 'OG000', 'lowerLimit': '-1.62', 'upperLimit': '-0.69'}, {'value': '-0.93', 'spread': '0.23', 'groupId': 'OG001', 'lowerLimit': '-1.40', 'upperLimit': '-0.47'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-1.31', 'spread': '0.23', 'groupId': 'OG000', 'lowerLimit': '-1.76', 'upperLimit': '-0.86'}, {'value': '-1.28', 'spread': '0.23', 'groupId': 'OG001', 'lowerLimit': '-1.73', 'upperLimit': '-0.84'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-1.36', 'spread': '0.27', 'groupId': 'OG000', 'lowerLimit': '-1.89', 'upperLimit': '-0.84'}, {'value': '-1.62', 'spread': '0.26', 'groupId': 'OG001', 'lowerLimit': '-2.14', 'upperLimit': '-1.10'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-1.18', 'spread': '0.27', 'groupId': 'OG000', 'lowerLimit': '-1.71', 'upperLimit': '-0.65'}, {'value': '-1.65', 'spread': '0.27', 'groupId': 'OG001', 'lowerLimit': '-2.17', 'upperLimit': '-1.12'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-1.35', 'spread': '0.26', 'groupId': 'OG000', 'lowerLimit': '-1.86', 'upperLimit': '-0.83'}, {'value': '-1.79', 'spread': '0.26', 'groupId': 'OG001', 'lowerLimit': '-2.30', 'upperLimit': '-1.28'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale:0=not at all distressing to 5=extremely distressing). The NPI Psychosis Subscale Caregiver Distress Score is calculated by adding Individual Item Scores for the domains of Delusions and Hallucinations, to yield a possible total score of 0 to 10. Lower score=less severity. A negative change score from baseline=improvement.', 'unitOfMeasure': 'Unit on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF data set, efficacy sample.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in NPI Total Caregiver Distress Score in Acute Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Baseline (Day 0)', 'categories': [{'measurements': [{'value': '16.58', 'spread': '0.87', 'groupId': 'OG000', 'lowerLimit': '14.87', 'upperLimit': '18.29'}, {'value': '17.06', 'spread': '0.86', 'groupId': 'OG001', 'lowerLimit': '15.37', 'upperLimit': '18.76'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '-1.81', 'spread': '0.65', 'groupId': 'OG000', 'lowerLimit': '-3.08', 'upperLimit': '-0.53'}, {'value': '-1.64', 'spread': '0.65', 'groupId': 'OG001', 'lowerLimit': '-2.92', 'upperLimit': '-0.36'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-3.25', 'spread': '0.72', 'groupId': 'OG000', 'lowerLimit': '-4.67', 'upperLimit': '-1.83'}, {'value': '-3.04', 'spread': '0.72', 'groupId': 'OG001', 'lowerLimit': '-4.47', 'upperLimit': '-1.61'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-4.10', 'spread': '0.81', 'groupId': 'OG000', 'lowerLimit': '-5.76', 'upperLimit': '-2.44'}, {'value': '-2.58', 'spread': '0.84', 'groupId': 'OG001', 'lowerLimit': '-4.25', 'upperLimit': '-0.92'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-4.01', 'spread': '0.80', 'groupId': 'OG000', 'lowerLimit': '-5.59', 'upperLimit': '-2.44'}, {'value': '-3.48', 'spread': '0.80', 'groupId': 'OG001', 'lowerLimit': '-5.06', 'upperLimit': '-1.90'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-3.58', 'spread': '0.98', 'groupId': 'OG000', 'lowerLimit': '-5.51', 'upperLimit': '-1.66'}, {'value': '-3.72', 'spread': '0.98', 'groupId': 'OG001', 'lowerLimit': '-5.65', 'upperLimit': '-1.79'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-3.20', 'spread': '0.99', 'groupId': 'OG000', 'lowerLimit': '-5.16', 'upperLimit': '-1.25'}, {'value': '-3.46', 'spread': '0.99', 'groupId': 'OG001', 'lowerLimit': '-5.42', 'upperLimit': '-1.50'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-3.15', 'spread': '1.03', 'groupId': 'OG000', 'lowerLimit': '-5.19', 'upperLimit': '-1.11'}, {'value': '-3.53', 'spread': '1.04', 'groupId': 'OG001', 'lowerLimit': '-5.57', 'upperLimit': '-1.48'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The total NPI Caregiver Distress Score is calculated by adding the 12 Caregiver Distress Individual Item Scores, to yield a possible total score of 0 to 60. Lower score=less severity. A negative change score from baseline indicates improvement.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF data set, efficacy sample.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score in Acute Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Baseline (Day 0)', 'categories': [{'measurements': [{'value': '4.84', 'spread': '0.09', 'groupId': 'OG000', 'lowerLimit': '4.67', 'upperLimit': '5.01'}, {'value': '4.83', 'spread': '0.09', 'groupId': 'OG001', 'lowerLimit': '4.66', 'upperLimit': '5.00'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.08', 'groupId': 'OG000', 'lowerLimit': '-0.34', 'upperLimit': '-0.04'}, {'value': '-0.10', 'spread': '0.08', 'groupId': 'OG001', 'lowerLimit': '-0.25', 'upperLimit': '0.05'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.11', 'groupId': 'OG000', 'lowerLimit': '-0.52', 'upperLimit': '-0.06'}, {'value': '-0.19', 'spread': '0.12', 'groupId': 'OG001', 'lowerLimit': '-0.41', 'upperLimit': '0.04'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-0.44', 'spread': '0.11', 'groupId': 'OG000', 'lowerLimit': '-0.65', 'upperLimit': '-0.22'}, {'value': '-0.44', 'spread': '0.11', 'groupId': 'OG001', 'lowerLimit': '-0.65', 'upperLimit': '-0.22'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.47', 'spread': '0.12', 'groupId': 'OG000', 'lowerLimit': '-0.70', 'upperLimit': '-0.24'}, {'value': '-0.49', 'spread': '0.12', 'groupId': 'OG001', 'lowerLimit': '-0.73', 'upperLimit': '-0.26'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-0.44', 'spread': '0.12', 'groupId': 'OG000', 'lowerLimit': '-0.69', 'upperLimit': '-0.20'}, {'value': '-0.58', 'spread': '0.12', 'groupId': 'OG001', 'lowerLimit': '-0.83', 'upperLimit': '-0.34'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.56', 'spread': '0.13', 'groupId': 'OG000', 'lowerLimit': '-0.83', 'upperLimit': '-0.30'}, {'value': '-0.65', 'spread': '0.13', 'groupId': 'OG001', 'lowerLimit': '-0.92', 'upperLimit': '-0.39'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-0.54', 'spread': '0.14', 'groupId': 'OG000', 'lowerLimit': '-0.82', 'upperLimit': '-0.26'}, {'value': '-0.69', 'spread': '0.14', 'groupId': 'OG001', 'lowerLimit': '-0.98', 'upperLimit': '-0.41'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': "The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Severity scale is a 7-point scale that requires the clinician to rate the severity of the illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. The assessment is based on severity of mental illness at the time of rating, 0=not assessed, 1=normal, 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill.", 'unitOfMeasure': 'Units on Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF data set, efficacy sample.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2). An additional participant did not have CGI-Severity score and was not included in the analysis'}, {'type': 'SECONDARY', 'title': 'CGI Improvement Score in Acute Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Week 1; n=98, 102', 'categories': [{'measurements': [{'value': '3.81', 'spread': '0.09', 'groupId': 'OG000', 'lowerLimit': '0.09'}, {'value': '3.96', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Week 2; n=98, 102', 'categories': [{'measurements': [{'value': '3.55', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '3.71', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Week 3; n=100, 103', 'categories': [{'measurements': [{'value': '3.37', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '3.49', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 4; n=100, 103', 'categories': [{'measurements': [{'value': '3.28', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '3.32', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 6; n=100, 103', 'categories': [{'measurements': [{'value': '3.26', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '3.23', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Week 8; n=100, 103', 'categories': [{'measurements': [{'value': '3.11', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '3.16', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Week 10; n=100, 103', 'categories': [{'measurements': [{'value': '3.07', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '3.17', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.133', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'CMH Row Means test with controlling for study center', 'groupDescription': 'Analysis at Week 1', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.282', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'CMH Row Means test with controlling for study center', 'groupDescription': 'Analysis at Week 2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.571', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'CMH Row Means test with controlling for study center', 'groupDescription': 'Analysis at Week 3', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.895', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'CMH Row Means test with controlling for study center', 'groupDescription': 'Analysis at Week 4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.817', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'CMH Row Means test with controlling for study center', 'groupDescription': 'Analysis at Week 6', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.795', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'CMH Row Means test with controlling for study center', 'groupDescription': 'Analysis at Week 8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.564', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'CMH Row Means test with controlling for study center', 'groupDescription': 'Analysis at Week 10', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': "The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Improvement scale is a 7 point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.", 'unitOfMeasure': 'Units on Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF data set, efficacy sample. n = Participants who had both post baseline and baseline values.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score in Acute Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Baseline (Day 0); n=95, 100', 'categories': [{'measurements': [{'value': '43.42', 'spread': '1.32', 'groupId': 'OG000', 'lowerLimit': '40.32', 'upperLimit': '46.02'}, {'value': '43.63', 'spread': '1.28', 'groupId': 'OG001', 'lowerLimit': '41.10', 'upperLimit': '46.16'}]}]}, {'title': 'Week 2; n=87, 95', 'categories': [{'measurements': [{'value': '-4.65', 'spread': '0.95', 'groupId': 'OG000', 'lowerLimit': '-6.54', 'upperLimit': '-2.77'}, {'value': '-5.82', 'spread': '0.94', 'groupId': 'OG001', 'lowerLimit': '-7.68', 'upperLimit': '-3.96'}]}]}, {'title': 'Week 4; n=95, 100', 'categories': [{'measurements': [{'value': '-5.80', 'spread': '0.97', 'groupId': 'OG000', 'lowerLimit': '-7.72', 'upperLimit': '-3.88'}, {'value': '-7.44', 'spread': '0.95', 'groupId': 'OG001', 'lowerLimit': '-9.31', 'upperLimit': '-5.58'}]}]}, {'title': 'Week 6; n=95, 100', 'categories': [{'measurements': [{'value': '-6.13', 'spread': '1.09', 'groupId': 'OG000', 'lowerLimit': '-8.29', 'upperLimit': '-3.97'}, {'value': '-8.50', 'spread': '1.07', 'groupId': 'OG001', 'lowerLimit': '-10.60', 'upperLimit': '-6.40'}]}]}, {'title': 'Week 8; n=95, 100', 'categories': [{'measurements': [{'value': '-6.45', 'spread': '1.17', 'groupId': 'OG000', 'lowerLimit': '-8.76', 'upperLimit': '-4.14'}, {'value': '-8.47', 'spread': '1.14', 'groupId': 'OG001', 'lowerLimit': '-10.72', 'upperLimit': '-6.22'}]}]}, {'title': 'Week 10; n=95, 100', 'categories': [{'measurements': [{'value': '-6.28', 'spread': '1.26', 'groupId': 'OG000', 'lowerLimit': '-9.07', 'upperLimit': '-4.09'}, {'value': '-8.53', 'spread': '1.23', 'groupId': 'OG001', 'lowerLimit': '-10.95', 'upperLimit': '-6.10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The BPRS is designed to measure clinical change in participants and is used as a global measure of psychopathology. The BPRS includes 18 items with items devoted to hallucinatory behavior, suspiciousness, unusual thought content, etc. BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126.\n\nA negative change score signifies improvement.', 'unitOfMeasure': 'Unit on Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF data set, efficacy sample. n = Participants who had both post baseline and baseline values.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mini Mental State Examination (MMSE) Total Score in Acute Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Baseline (Day 0); N=86,94', 'categories': [{'measurements': [{'value': '14.13', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '14.35', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Week 10; n=82, 87', 'categories': [{'measurements': [{'value': '0.53', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '-0.81', 'spread': '0.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.733', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '-1.08', 'ciUpperLimit': '1.54', 'groupDescription': 'Analysis at baseline', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.35', 'ciLowerLimit': '-2.16', 'ciUpperLimit': '-0.54', 'groupDescription': 'Analysis at Week 10', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Week 10', 'description': 'The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language). It is a 19 item scale, the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline.', 'unitOfMeasure': 'Units on Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF data set, efficacy sample. n=Participants who had both post baseline and baseline values.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data set: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Delusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Baseline (Day 0)', 'categories': [{'measurements': [{'value': '7.85', 'groupId': 'OG000', 'lowerLimit': '7.29', 'upperLimit': '8.41'}, {'value': '8.11', 'groupId': 'OG001', 'lowerLimit': '7.55', 'upperLimit': '8.67'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '-2.37', 'groupId': 'OG000', 'lowerLimit': '-3.02', 'upperLimit': '-1.71'}, {'value': '-1.61', 'groupId': 'OG001', 'lowerLimit': '-2.25', 'upperLimit': '-0.97'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-2.84', 'groupId': 'OG000', 'lowerLimit': '-3.69', 'upperLimit': '-1.98'}, {'value': '-2.72', 'groupId': 'OG001', 'lowerLimit': '-3.57', 'upperLimit': '-1.88'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-3.25', 'groupId': 'OG000', 'lowerLimit': '-4.07', 'upperLimit': '-2.42'}, {'value': '-3.50', 'groupId': 'OG001', 'lowerLimit': '-4.32', 'upperLimit': '-2.69'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-3.72', 'groupId': 'OG000', 'lowerLimit': '-4.54', 'upperLimit': '-2.90'}, {'value': '-3.89', 'groupId': 'OG001', 'lowerLimit': '-4.69', 'upperLimit': '-3.08'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-3.45', 'groupId': 'OG000', 'lowerLimit': '-4.28', 'upperLimit': '-2.61'}, {'value': '-3.95', 'groupId': 'OG001', 'lowerLimit': '-4.78', 'upperLimit': '-3.13'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-3.52', 'groupId': 'OG000', 'lowerLimit': '-4.41', 'upperLimit': '-2.63'}, {'value': '-3.91', 'groupId': 'OG001', 'lowerLimit': '-4.79', 'upperLimit': '-3.03'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-3.94', 'groupId': 'OG000', 'lowerLimit': '-4.81', 'upperLimit': '-3.07'}, {'value': '-4.28', 'groupId': 'OG001', 'lowerLimit': '-5.14', 'upperLimit': '-3.43'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF data set, efficacy sample.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Hallucinations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Baseline (Day 0)', 'categories': [{'measurements': [{'value': '4.27', 'groupId': 'OG000', 'lowerLimit': '3.25', 'upperLimit': '5.29'}, {'value': '4.18', 'groupId': 'OG001', 'lowerLimit': '3.17', 'upperLimit': '5.19'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '-0.98', 'groupId': 'OG000', 'lowerLimit': '-1.63', 'upperLimit': '-0.32'}, {'value': '-0.65', 'groupId': 'OG001', 'lowerLimit': '-1.30', 'upperLimit': '0.00'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-1.15', 'groupId': 'OG000', 'lowerLimit': '-1.86', 'upperLimit': '-0.43'}, {'value': '-1.09', 'groupId': 'OG001', 'lowerLimit': '-1.80', 'upperLimit': '-0.38'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-1.34', 'groupId': 'OG000', 'lowerLimit': '-2.05', 'upperLimit': '-0.63'}, {'value': '-1.37', 'groupId': 'OG001', 'lowerLimit': '-2.08', 'upperLimit': '-0.67'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-1.71', 'groupId': 'OG000', 'lowerLimit': '-2.31', 'upperLimit': '-1.10'}, {'value': '-1.79', 'groupId': 'OG001', 'lowerLimit': '-2.40', 'upperLimit': '-1.19'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-1.43', 'groupId': 'OG000', 'lowerLimit': '-2.02', 'upperLimit': '-0.84'}, {'value': '-2.03', 'groupId': 'OG001', 'lowerLimit': '-2.62', 'upperLimit': '-1.45'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-1.57', 'groupId': 'OG000', 'lowerLimit': '-2.22', 'upperLimit': '-0.91'}, {'value': '-2.12', 'groupId': 'OG001', 'lowerLimit': '-2.77', 'upperLimit': '-1.47'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-1.65', 'groupId': 'OG000', 'lowerLimit': '-2.28', 'upperLimit': '-1.03'}, {'value': '-2.30', 'groupId': 'OG001', 'lowerLimit': '-2.92', 'upperLimit': '-1.67'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF data set, efficacy sample.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Agitation/Aggression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Baseline (Day 0)', 'categories': [{'measurements': [{'value': '3.52', 'groupId': 'OG000', 'lowerLimit': '2.68', 'upperLimit': '4.37'}, {'value': '4.04', 'groupId': 'OG001', 'lowerLimit': '3.20', 'upperLimit': '4.87'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '-0.34', 'groupId': 'OG000', 'lowerLimit': '-1.12', 'upperLimit': '0.43'}, {'value': '0.10', 'groupId': 'OG001', 'lowerLimit': '-0.68', 'upperLimit': '0.88'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-1.16', 'groupId': 'OG000', 'lowerLimit': '-1.86', 'upperLimit': '-0.47'}, {'value': '-0.69', 'groupId': 'OG001', 'lowerLimit': '-1.38', 'upperLimit': '0.01'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-0.73', 'groupId': 'OG000', 'lowerLimit': '-1.50', 'upperLimit': '0.03'}, {'value': '-0.59', 'groupId': 'OG001', 'lowerLimit': '-1.35', 'upperLimit': '0.17'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.78', 'groupId': 'OG000', 'lowerLimit': '-1.51', 'upperLimit': '-0.05'}, {'value': '-1.38', 'groupId': 'OG001', 'lowerLimit': '-2.11', 'upperLimit': '-0.65'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-0.31', 'groupId': 'OG000', 'lowerLimit': '-1.08', 'upperLimit': '0.46'}, {'value': '-0.94', 'groupId': 'OG001', 'lowerLimit': '-1.71', 'upperLimit': '-0.18'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.12', 'groupId': 'OG000', 'lowerLimit': '-0.94', 'upperLimit': '0.69'}, {'value': '-0.84', 'groupId': 'OG001', 'lowerLimit': '-1.65', 'upperLimit': '-0.03'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-0.47', 'groupId': 'OG000', 'lowerLimit': '-1.32', 'upperLimit': '0.37'}, {'value': '-1.12', 'groupId': 'OG001', 'lowerLimit': '-1.96', 'upperLimit': '-0.28'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF data set, efficacy sample.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Depression/Dysphoria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Baseline (Day 0)', 'categories': [{'measurements': [{'value': '3.27', 'groupId': 'OG000', 'lowerLimit': '2.59', 'upperLimit': '3.95'}, {'value': '2.28', 'groupId': 'OG001', 'lowerLimit': '1.60', 'upperLimit': '2.95'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000', 'lowerLimit': '-0.39', 'upperLimit': '0.81'}, {'value': '-0.04', 'groupId': 'OG001', 'lowerLimit': '-0.62', 'upperLimit': '0.54'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.44', 'groupId': 'OG000', 'lowerLimit': '-1.01', 'upperLimit': '0.13'}, {'value': '-0.36', 'groupId': 'OG001', 'lowerLimit': '-0.91', 'upperLimit': '0.19'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-0.77', 'groupId': 'OG000', 'lowerLimit': '-1.28', 'upperLimit': '-0.25'}, {'value': '-0.33', 'groupId': 'OG001', 'lowerLimit': '-0.84', 'upperLimit': '0.17'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.72', 'groupId': 'OG000', 'lowerLimit': '-1.22', 'upperLimit': '-0.22'}, {'value': '-0.50', 'groupId': 'OG001', 'lowerLimit': '-0.99', 'upperLimit': '-0.02'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-0.47', 'groupId': 'OG000', 'lowerLimit': '-1.04', 'upperLimit': '0.10'}, {'value': '-0.55', 'groupId': 'OG001', 'lowerLimit': '-1.10', 'upperLimit': '0.00'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.65', 'groupId': 'OG000', 'lowerLimit': '-1.20', 'upperLimit': '-0.11'}, {'value': '-0.54', 'groupId': 'OG001', 'lowerLimit': '-1.07', 'upperLimit': '-0.01'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-0.32', 'groupId': 'OG000', 'lowerLimit': '-0.95', 'upperLimit': '0.32'}, {'value': '-0.42', 'groupId': 'OG001', 'lowerLimit': '-1.04', 'upperLimit': '0.19'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF data set, efficacy sample.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Baseline (Day 0)', 'categories': [{'measurements': [{'value': '3.64', 'groupId': 'OG000', 'lowerLimit': '2.81', 'upperLimit': '4.46'}, {'value': '3.17', 'groupId': 'OG001', 'lowerLimit': '2.36', 'upperLimit': '3.99'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '-0.73', 'upperLimit': '0.77'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '-0.69', 'upperLimit': '0.79'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.08', 'groupId': 'OG000', 'lowerLimit': '-0.73', 'upperLimit': '0.58'}, {'value': '0.08', 'groupId': 'OG001', 'lowerLimit': '-0.56', 'upperLimit': '0.72'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-0.43', 'groupId': 'OG000', 'lowerLimit': '-1.14', 'upperLimit': '0.29'}, {'value': '0.07', 'groupId': 'OG001', 'lowerLimit': '-0.63', 'upperLimit': '0.77'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.80', 'groupId': 'OG000', 'lowerLimit': '-1.47', 'upperLimit': '-0.14'}, {'value': '-0.38', 'groupId': 'OG001', 'lowerLimit': '-1.03', 'upperLimit': '0.27'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-0.79', 'groupId': 'OG000', 'lowerLimit': '-1.49', 'upperLimit': '-0.08'}, {'value': '-0.13', 'groupId': 'OG001', 'lowerLimit': '-0.82', 'upperLimit': '0.57'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.23', 'groupId': 'OG000', 'lowerLimit': '-0.90', 'upperLimit': '0.44'}, {'value': '-0.21', 'groupId': 'OG001', 'lowerLimit': '-0.87', 'upperLimit': '0.46'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-0.43', 'groupId': 'OG000', 'lowerLimit': '-1.13', 'upperLimit': '0.26'}, {'value': '-0.31', 'groupId': 'OG001', 'lowerLimit': '-0.99', 'upperLimit': '0.37'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF data set, efficacy sample.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Apathy/Indifference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Baseline (Day 0)', 'categories': [{'measurements': [{'value': '4.14', 'groupId': 'OG000', 'lowerLimit': '3.41', 'upperLimit': '4.86'}, {'value': '3.47', 'groupId': 'OG001', 'lowerLimit': '2.75', 'upperLimit': '4.19'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '-0.66', 'upperLimit': '0.71'}, {'value': '-0.70', 'groupId': 'OG001', 'lowerLimit': '-1.37', 'upperLimit': '-0.03'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.48', 'groupId': 'OG000', 'lowerLimit': '-1.11', 'upperLimit': '0.15'}, {'value': '-0.76', 'groupId': 'OG001', 'lowerLimit': '-1.37', 'upperLimit': '-0.14'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-0.09', 'groupId': 'OG000', 'lowerLimit': '-0.80', 'upperLimit': '0.62'}, {'value': '-0.36', 'groupId': 'OG001', 'lowerLimit': '-1.06', 'upperLimit': '0.33'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.65', 'groupId': 'OG000', 'lowerLimit': '-1.39', 'upperLimit': '0.10'}, {'value': '-0.67', 'groupId': 'OG001', 'lowerLimit': '-1.40', 'upperLimit': '0.06'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-0.63', 'groupId': 'OG000', 'lowerLimit': '-1.43', 'upperLimit': '0.17'}, {'value': '-0.40', 'groupId': 'OG001', 'lowerLimit': '-1.18', 'upperLimit': '0.38'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.87', 'groupId': 'OG000', 'lowerLimit': '-1.60', 'upperLimit': '-0.15'}, {'value': '-0.21', 'groupId': 'OG001', 'lowerLimit': '-0.92', 'upperLimit': '0.49'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-0.95', 'groupId': 'OG000', 'lowerLimit': '-1.78', 'upperLimit': '-0.11'}, {'value': '-0.09', 'groupId': 'OG001', 'lowerLimit': '-0.91', 'upperLimit': '0.72'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF data set, efficacy sample.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Elation/Euphoria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Baseline (Day 0)', 'categories': [{'measurements': [{'value': '0.56', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '1.05'}, {'value': '0.73', 'groupId': 'OG001', 'lowerLimit': '0.24', 'upperLimit': '1.23'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '-0.48', 'groupId': 'OG000', 'lowerLimit': '-0.75', 'upperLimit': '-0.22'}, {'value': '-0.26', 'groupId': 'OG001', 'lowerLimit': '-0.52', 'upperLimit': '0.01'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.37', 'groupId': 'OG000', 'lowerLimit': '-0.63', 'upperLimit': '-0.11'}, {'value': '-0.18', 'groupId': 'OG001', 'lowerLimit': '-0.43', 'upperLimit': '0.08'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-0.48', 'groupId': 'OG000', 'lowerLimit': '-0.76', 'upperLimit': '-0.20'}, {'value': '-0.27', 'groupId': 'OG001', 'lowerLimit': '-0.54', 'upperLimit': '0.01'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.47', 'groupId': 'OG000', 'lowerLimit': '-0.66', 'upperLimit': '-0.28'}, {'value': '-0.40', 'groupId': 'OG001', 'lowerLimit': '-0.59', 'upperLimit': '-0.21'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-0.38', 'groupId': 'OG000', 'lowerLimit': '-0.58', 'upperLimit': '-0.18'}, {'value': '-0.39', 'groupId': 'OG001', 'lowerLimit': '-0.59', 'upperLimit': '-0.20'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.32', 'groupId': 'OG000', 'lowerLimit': '-0.59', 'upperLimit': '-0.04'}, {'value': '-0.25', 'groupId': 'OG001', 'lowerLimit': '-0.52', 'upperLimit': '0.03'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-0.42', 'groupId': 'OG000', 'lowerLimit': '-0.65', 'upperLimit': '-0.19'}, {'value': '-0.36', 'groupId': 'OG001', 'lowerLimit': '-0.59', 'upperLimit': '-0.14'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF data set, efficacy sample.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Disinhibition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Baseline (Day 0)', 'categories': [{'measurements': [{'value': '0.98', 'groupId': 'OG000', 'lowerLimit': '0.39', 'upperLimit': '1.57'}, {'value': '1.36', 'groupId': 'OG001', 'lowerLimit': '0.77', 'upperLimit': '1.94'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '-0.14', 'groupId': 'OG000', 'lowerLimit': '-0.54', 'upperLimit': '0.25'}, {'value': '-0.39', 'groupId': 'OG001', 'lowerLimit': '-0.79', 'upperLimit': '0.00'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.42', 'groupId': 'OG000', 'lowerLimit': '-0.91', 'upperLimit': '0.07'}, {'value': '-0.44', 'groupId': 'OG001', 'lowerLimit': '-0.93', 'upperLimit': '0.05'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-0.27', 'groupId': 'OG000', 'lowerLimit': '-0.86', 'upperLimit': '0.32'}, {'value': '-0.21', 'groupId': 'OG001', 'lowerLimit': '-0.80', 'upperLimit': '0.38'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.55', 'groupId': 'OG000', 'lowerLimit': '-1.04', 'upperLimit': '-0.06'}, {'value': '-0.67', 'groupId': 'OG001', 'lowerLimit': '-1.16', 'upperLimit': '-0.19'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-0.19', 'groupId': 'OG000', 'lowerLimit': '-0.64', 'upperLimit': '0.26'}, {'value': '-0.72', 'groupId': 'OG001', 'lowerLimit': '-1.17', 'upperLimit': '-0.28'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.20', 'groupId': 'OG000', 'lowerLimit': '-0.67', 'upperLimit': '0.28'}, {'value': '-0.44', 'groupId': 'OG001', 'lowerLimit': '-0.91', 'upperLimit': '0.03'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '-0.47', 'upperLimit': '0.60'}, {'value': '-0.35', 'groupId': 'OG001', 'lowerLimit': '-0.88', 'upperLimit': '0.18'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. 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A negative change score from baseline indicates improvement.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF data set, efficacy sample.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Irritability/Lability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Baseline (Day 0)', 'categories': [{'measurements': [{'value': '3.73', 'groupId': 'OG000', 'lowerLimit': '2.80', 'upperLimit': '4.66'}, {'value': '4.36', 'groupId': 'OG001', 'lowerLimit': '3.44', 'upperLimit': '5.28'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '-0.73', 'groupId': 'OG000', 'lowerLimit': '-1.48', 'upperLimit': '0.02'}, {'value': '-0.09', 'groupId': 'OG001', 'lowerLimit': '-0.84', 'upperLimit': '0.66'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.89', 'groupId': 'OG000', 'lowerLimit': '-1.65', 'upperLimit': '-0.12'}, {'value': '-0.69', 'groupId': 'OG001', 'lowerLimit': '-1.45', 'upperLimit': '0.08'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-1.11', 'groupId': 'OG000', 'lowerLimit': '-1.89', 'upperLimit': '-0.32'}, {'value': '-1.09', 'groupId': 'OG001', 'lowerLimit': '-1.87', 'upperLimit': '-0.30'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.75', 'groupId': 'OG000', 'lowerLimit': '-1.53', 'upperLimit': '0.02'}, {'value': '-1.53', 'groupId': 'OG001', 'lowerLimit': '-2.30', 'upperLimit': '-0.76'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-0.42', 'groupId': 'OG000', 'lowerLimit': '-1.19', 'upperLimit': '0.36'}, {'value': '-1.29', 'groupId': 'OG001', 'lowerLimit': '-2.06', 'upperLimit': '-0.51'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.33', 'groupId': 'OG000', 'lowerLimit': '-1.16', 'upperLimit': '0.50'}, {'value': '-0.99', 'groupId': 'OG001', 'lowerLimit': '-1.82', 'upperLimit': '-0.16'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-0.24', 'groupId': 'OG000', 'lowerLimit': '-1.02', 'upperLimit': '0.53'}, {'value': '-1.26', 'groupId': 'OG001', 'lowerLimit': '-2.03', 'upperLimit': '-0.48'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF data set, efficacy sample.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Aberrant Motor Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Baseline (Day 0)', 'categories': [{'measurements': [{'value': '3.67', 'groupId': 'OG000', 'lowerLimit': '2.69', 'upperLimit': '4.66'}, {'value': '3.61', 'groupId': 'OG001', 'lowerLimit': '2.63', 'upperLimit': '4.59'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '-0.66', 'groupId': 'OG000', 'lowerLimit': '-1.26', 'upperLimit': '-0.06'}, {'value': '0.18', 'groupId': 'OG001', 'lowerLimit': '-0.42', 'upperLimit': '0.77'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.84', 'groupId': 'OG000', 'lowerLimit': '-1.63', 'upperLimit': '-0.06'}, {'value': '-0.51', 'groupId': 'OG001', 'lowerLimit': '-1.29', 'upperLimit': '0.27'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-1.68', 'groupId': 'OG000', 'lowerLimit': '-2.45', 'upperLimit': '-0.09'}, {'value': '-0.66', 'groupId': 'OG001', 'lowerLimit': '-1.43', 'upperLimit': '0.12'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.91', 'groupId': 'OG000', 'lowerLimit': '-1.73', 'upperLimit': '-0.09'}, {'value': '-0.16', 'groupId': 'OG001', 'lowerLimit': '-0.98', 'upperLimit': '0.65'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-0.89', 'groupId': 'OG000', 'lowerLimit': '-1.64', 'upperLimit': '-0.13'}, {'value': '-0.61', 'groupId': 'OG001', 'lowerLimit': '-1.36', 'upperLimit': '0.14'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-1.06', 'groupId': 'OG000', 'lowerLimit': '-1.78', 'upperLimit': '-0.33'}, {'value': '-0.83', 'groupId': 'OG001', 'lowerLimit': '-1.55', 'upperLimit': '-0.11'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-1.02', 'groupId': 'OG000', 'lowerLimit': '-1.83', 'upperLimit': '-0.22'}, {'value': '-0.89', 'groupId': 'OG001', 'lowerLimit': '-1.69', 'upperLimit': '-0.09'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF data set, efficacy sample.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Appetite/Eating Behaviors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Baseline (Day 0)', 'categories': [{'measurements': [{'value': '1.78', 'groupId': 'OG000', 'lowerLimit': '1.18', 'upperLimit': '2.39'}, {'value': '1.47', 'groupId': 'OG001', 'lowerLimit': '0.87', 'upperLimit': '2.07'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '-0.24', 'groupId': 'OG000', 'lowerLimit': '-0.73', 'upperLimit': '0.25'}, {'value': '-0.18', 'groupId': 'OG001', 'lowerLimit': '-0.66', 'upperLimit': '0.30'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.36', 'groupId': 'OG000', 'lowerLimit': '-0.84', 'upperLimit': '0.12'}, {'value': '-0.21', 'groupId': 'OG001', 'lowerLimit': '-0.68', 'upperLimit': '0.26'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-0.14', 'groupId': 'OG000', 'lowerLimit': '-0.65', 'upperLimit': '0.36'}, {'value': '0.23', 'groupId': 'OG001', 'lowerLimit': '-0.27', 'upperLimit': '0.73'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.44', 'groupId': 'OG000', 'lowerLimit': '-0.96', 'upperLimit': '0.07'}, {'value': '-0.04', 'groupId': 'OG001', 'lowerLimit': '-0.55', 'upperLimit': '0.47'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-0.27', 'groupId': 'OG000', 'lowerLimit': '-0.96', 'upperLimit': '0.42'}, {'value': '0.23', 'groupId': 'OG001', 'lowerLimit': '-0.45', 'upperLimit': '0.91'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.11', 'groupId': 'OG000', 'lowerLimit': '-0.72', 'upperLimit': '0.49'}, {'value': '0.45', 'groupId': 'OG001', 'lowerLimit': '-0.15', 'upperLimit': '1.05'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-0.17', 'groupId': 'OG000', 'lowerLimit': '-0.79', 'upperLimit': '0.46'}, {'value': '0.56', 'groupId': 'OG001', 'lowerLimit': '-0.05', 'upperLimit': '1.17'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF data set, efficacy sample.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Baseline (Day 0)', 'categories': [{'measurements': [{'value': '2.67', 'groupId': 'OG000', 'lowerLimit': '1.78', 'upperLimit': '3.55'}, {'value': '3.03', 'groupId': 'OG001', 'lowerLimit': '2.15', 'upperLimit': '3.91'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '-0.10', 'groupId': 'OG000', 'lowerLimit': '-0.84', 'upperLimit': '0.64'}, {'value': '-0.07', 'groupId': 'OG001', 'lowerLimit': '-0.81', 'upperLimit': '0.67'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.20', 'groupId': 'OG000', 'lowerLimit': '-0.95', 'upperLimit': '0.55'}, {'value': '-0.07', 'groupId': 'OG001', 'lowerLimit': '-0.82', 'upperLimit': '0.67'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-0.20', 'groupId': 'OG000', 'lowerLimit': '-0.98', 'upperLimit': '0.58'}, {'value': '0.10', 'groupId': 'OG001', 'lowerLimit': '-0.68', 'upperLimit': '0.87'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '-0.65', 'upperLimit': '0.70'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '-0.53', 'upperLimit': '0.82'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-0.39', 'groupId': 'OG000', 'lowerLimit': '-1.12', 'upperLimit': '0.34'}, {'value': '-0.03', 'groupId': 'OG001', 'lowerLimit': '-0.76', 'upperLimit': '0.69'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.06', 'groupId': 'OG000', 'lowerLimit': '-0.80', 'upperLimit': '0.68'}, {'value': '-0.06', 'groupId': 'OG001', 'lowerLimit': '-0.79', 'upperLimit': '0.68'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '-0.69', 'upperLimit': '0.79'}, {'value': '-0.06', 'groupId': 'OG001', 'lowerLimit': '-0.80', 'upperLimit': '0.67'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF data set, efficacy sample.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Simpson-Angus Scale (SAS) Total Score in Acute Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Baseline (Day 0); n=97, 100', 'categories': [{'measurements': [{'value': '14.41', 'spread': 'NA', 'groupId': 'OG000', 'lowerLimit': '13.37', 'upperLimit': '15.46'}, {'value': '14.47', 'spread': 'NA', 'groupId': 'OG001', 'lowerLimit': '13.45', 'upperLimit': '15.50'}]}]}, {'title': 'Week 2; n=89, 94', 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '-0.49', 'upperLimit': '0.52'}, {'value': '-0.35', 'groupId': 'OG001', 'lowerLimit': '-0.84', 'upperLimit': '0.14'}]}]}, {'title': 'Week 4; n=93, 96', 'categories': [{'measurements': [{'value': '-0.15', 'groupId': 'OG000', 'lowerLimit': '-0.76', 'upperLimit': '0.45'}, {'value': '-0.06', 'groupId': 'OG001', 'lowerLimit': '-0.65', 'upperLimit': '0.54'}]}]}, {'title': 'Week 10; n=82, 85', 'categories': [{'measurements': [{'value': '-0.44', 'groupId': 'OG000', 'lowerLimit': '-1.19', 'upperLimit': '0.31'}, {'value': '0.33', 'groupId': 'OG001', 'lowerLimit': '-0.40', 'upperLimit': '1.07'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Weeks 2, 4, and 10', 'description': 'The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50.(lower score=less severe). Negative change scores indicate improvement.', 'unitOfMeasure': 'Units on scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed cases data set, Efficacy Sample. n=Participants who had both post baseline and baseline values.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data set: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score in Acute Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Baseline (Day 0); n=99, 101', 'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000', 'lowerLimit': '0.32', 'upperLimit': '1.42'}, {'value': '0.93', 'groupId': 'OG001', 'lowerLimit': '0.39', 'upperLimit': '1.48'}]}]}, {'title': 'Week 2; n=91, 95', 'categories': [{'measurements': [{'value': '-0.10', 'groupId': 'OG000', 'lowerLimit': '-0.25', 'upperLimit': '0.04'}, {'value': '-0.17', 'groupId': 'OG001', 'lowerLimit': '-0.32', 'upperLimit': '-0.03'}]}]}, {'title': 'Week 4; n=97, 97', 'categories': [{'measurements': [{'value': '-0.05', 'groupId': 'OG000', 'lowerLimit': '-0.30', 'upperLimit': '0.19'}, {'value': '-0.08', 'groupId': 'OG001', 'lowerLimit': '-0.33', 'upperLimit': '0.17'}]}]}, {'title': 'Week 8; n=87, 87', 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '-0.30', 'upperLimit': '0.44'}, {'value': '-0.14', 'groupId': 'OG001', 'lowerLimit': '-0.51', 'upperLimit': '0.23'}]}]}, {'title': 'Week 10; n=85, 87', 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '-0.33', 'upperLimit': '0.43'}, {'value': '-0.17', 'groupId': 'OG001', 'lowerLimit': '-0.55', 'upperLimit': '0.20'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Weeks 2, 4, 8, and 10', 'description': "The Abnormal Involuntary Movement Scale (AIMS) is a rating scale that was designed to measure involuntary movements (tardive dyskinesia). The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body. These items are rated on a five-point scale of severity from 0-4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe).\n\nAIMS Total Score is from 0 to 28. A negative change score signifies improvement.", 'unitOfMeasure': 'Units on scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed Cased data set, efficacy sample. n=Participants who had both post baseline and baseline values.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data set: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Barnes Global Clinical Assessment of Akathisia in Acute Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Baseline (Day 0); n=100,101', 'categories': [{'measurements': [{'value': '0.20', 'groupId': 'OG000', 'lowerLimit': '0.09', 'upperLimit': '0.31'}, {'value': '0.19', 'groupId': 'OG001', 'lowerLimit': '0.07', 'upperLimit': '0.30'}]}]}, {'title': 'Week 1; n=99, 101', 'categories': [{'measurements': [{'value': '-0.06', 'groupId': 'OG000', 'lowerLimit': '-0.12', 'upperLimit': '0.00'}, {'value': '-0.06', 'groupId': 'OG001', 'lowerLimit': '-0.12', 'upperLimit': '0.00'}]}]}, {'title': 'Week 2; n=91, 95', 'categories': [{'measurements': [{'value': '-0.02', 'groupId': 'OG000', 'lowerLimit': '-0.07', 'upperLimit': '0.03'}, {'value': '-0.05', 'groupId': 'OG001', 'lowerLimit': '-0.11', 'upperLimit': '0.00'}]}]}, {'title': 'Week 3; n=95, 99', 'categories': [{'measurements': [{'value': '-0.03', 'groupId': 'OG000', 'lowerLimit': '-0.08', 'upperLimit': '0.02'}, {'value': '-0.06', 'groupId': 'OG001', 'lowerLimit': '-0.11', 'upperLimit': '-0.01'}]}]}, {'title': 'Week 4; n=97, 98', 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'groupId': 'OG000', 'lowerLimit': '-0.07', 'upperLimit': '0.07'}, {'value': '-0.08', 'groupId': 'OG001', 'lowerLimit': '-0.15', 'upperLimit': '-0.02'}]}]}, {'title': 'Week 6; n=91, 92', 'categories': [{'measurements': [{'value': '-0.07', 'groupId': 'OG000', 'lowerLimit': '-0.14', 'upperLimit': '-0.01'}, {'value': '-0.02', 'groupId': 'OG001', 'lowerLimit': '-0.09', 'upperLimit': '0.04'}]}]}, {'title': 'Week 8; n=87, 87', 'categories': [{'measurements': [{'value': '-0.05', 'groupId': 'OG000', 'lowerLimit': '-0.11', 'upperLimit': '0.01'}, {'value': '-0.03', 'groupId': 'OG001', 'lowerLimit': '-0.09', 'upperLimit': '0.03'}]}]}, {'title': 'Week 10; n=85, 87', 'categories': [{'measurements': [{'value': '-0.05', 'groupId': 'OG000', 'lowerLimit': '-0.11', 'upperLimit': '0.00'}, {'value': '-0.05', 'groupId': 'OG001', 'lowerLimit': '-0.11', 'upperLimit': '0.01'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.', 'unitOfMeasure': 'Unit on scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed cases data set, efficacy sample. n=Participants with both post-baseline and baseline measures.\n\nOf the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)'}, {'type': 'SECONDARY', 'title': 'Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events in Acute Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Dyskinesia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Extrapyramidal syndrome', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hypertonia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypokinesia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Tremor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1 to week 10', 'description': 'Extrapyramidal symptoms (EPS) are various movement disorders such as acute dystonic reactions, pseudoparkinsonism, or akathisia', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication.'}, {'type': 'SECONDARY', 'title': 'Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs in Acute Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Any adverse event (AE)', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Serious adverse event', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Discontinuations due to AE', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1 to week 10', 'description': 'AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication.'}, {'type': 'SECONDARY', 'title': 'Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Alanine aminotransferase ≥3 x ULN; n=98, 98', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase ≥3 x ULN; n=98, 98', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase ≥3 x ULN; n=98, 98', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatine phosphokinase (total) ≥3 x ULN; n=98, 98', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine ≥ 2.0 mg/dL; n=98, 98', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Uric acid ≥8.5 mg/dL (F);≥10.5 mg/dL(M); n=98, 98', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Calcium ≥ 10.6 mg/dL; n=98, 98', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Calcium ≤ 8.4 mg/dL; n=98, 98', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Serum Chloride ≥ 113 mEq/L; n=98, 98', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Serum Chloride ≤ 93 mEq/L; n=98, 98', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol Total > ULN; n=98, 98', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol Total < LLN; n=98, 98', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serum Glucose Fasting > ULN; n=36, 31', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Serum Potassium ≥ 5.6 mEq/L; n=98, 98', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Serum Potassium ≤ 3.4 mEq/L; n=98, 98', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Serum Sodium ≥ 148 mEq/L; n=98, 98', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Serum Sodium ≤ 132 mEq/L; n=98, 98', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Urea ≥ 10.1mmol/L; n=98, 97', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Platelet ≥ 700,000 mm3; n=97, 96', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Platelet ≤ 75,000 mm3; n=97, 96', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils ≥ 10%; n=97, 96', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit ≤ 37% (M)/≤ 32% (F); n=97, 96', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin ≤ 11.5 (M)/≤ 9.5 g/dL (F); n=97, 96', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Urine Glucose ≥ 2-unit increase; n=92, 93', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urine Protein ≥ 2-unit increase; n=92, 93', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1 to Week 10', 'description': 'Criteria for identifying potentially clinically significant laboratory values were based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products. Normal ranges are local lab data and vary according to the site. M=male, F=female. Criteria for hematocrit also includes a 3 point shift from baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication. n=Participants with values for laboratory findings'}, {'type': 'SECONDARY', 'title': 'Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks)'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: Dosed at 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Increased Systolic BP, standing; n=99, 100', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Decreased Systolic BP, standing; n=99, 100', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Increased Systolic BP, supine; n=101, 102', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Decreased Systolic BP, supine; n=101, 102', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Decreased Systolic BP, sitting; n=13, 20', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Increased Diastolic BP, standing; n=99, 100', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Decreased Diastolic BP, standing; n=99, 100', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Increased Diastolic BP, supine; n=101, 102', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Decreased Diastolic BP, supine; n=101, 102', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Decreased Diastolic BP, sitting; n=13, 20', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Increased Heart rate, standing; n=99, 100', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Decreased Heart rate, standing; n=99, 100', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Decreased Heart rate, supine; n=101, 102', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Increased Weight; n=89, 93', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Decreased Weight; n=89,93', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1 to week 10', 'description': 'Systolic BP: increase defined as ≥180 and a ≥20-mmHg increase from baseline (BL); decrease defined as ≤90 and a ≥20mmHg decrease from BL. Diastolic BP: increase defined as ≥105 and a ≥15mmHg decrease from BL, decrease defined as ≤50 and a ≥15mmHg decrease from BL. Heart rate: increase defined as ≥120 and ≥15bpm increase from BL, decrease defined as ≤50 and ≥15bpm decrease from BL; Weight: increase defined as ≥7% from BL, decrease defined as ≤7% decrease BL. Criteria for identifying PCS measurements are based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication. n=Participants with values for vital signs'}, {'type': 'SECONDARY', 'title': 'Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks'}, {'id': 'OG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'classes': [{'title': 'Bradycardia; n=99, 102', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Sinus Bradycardia; n=99, 102', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Supraventricular premature beat; n=99, 102', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Ventricular premature beat; n=99, 102', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Supraventricular tachycardia; n=99, 102', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Atrial fibrillation; n=99, 102', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Atrial flutter; n=99, 102', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '1st degree A-V Block; n=95, 97', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Left bundle branch block; n=99, 102', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Right bundle branch block; n=99, 102', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Other intraventricular conduction block; n=99, 102', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Subacute infarction; n=99, 102', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Old infarction; n=99, 102', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Myocardial ischemia; n=99, 102', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Symmetrical T-wave inversion; n=99, 102', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Inc QTcB (≥450 msec≥,10% from baseline); n=99, 102', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Inc QTcN (≥450 msec,≥10% from baseline); n=99, 102', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1 to Week 10', 'description': 'Bradycardia:Heart rate ≤50 bpm and ≥15 bpm decrease from baseline; Supraventricular premature beat: ≥2 per 10 seconds and any increase from baseline; 1st degree A-V Block: PR ≥0.20 seconds and increase of ≥0.05 second from baseline; Intraventricular conduction block:QRS ≥0.12 second and increase of ≥0.02 second from baseline; QTcB= ≥450 msec and ≥10% increase from baseline; QTcN =≥450 msec and ≥10% increase from baseline. All other events were not present at baseline but observed during the study. Inc=increase', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication. n=Participants who were evaluated for electrocardiogram'}, {'type': 'SECONDARY', 'title': 'Change in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score From Baseline During Extension Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole', 'description': 'Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).'}], 'classes': [{'title': 'Baseline, Day 0 (n=154)', 'categories': [{'measurements': [{'value': '12.312', 'spread': '0.426', 'groupId': 'OG000'}]}]}, {'title': 'Week 18 (n=151)', 'categories': [{'measurements': [{'value': '-8.589', 'spread': '0.548', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (n=139)', 'categories': [{'measurements': [{'value': '-8.993', 'spread': '0.589', 'groupId': 'OG000'}]}]}, {'title': 'Week 40 (n=115)', 'categories': [{'measurements': [{'value': '-8.270', 'spread': '0.677', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (n=98)', 'categories': [{'measurements': [{'value': '-8.582', 'spread': '0.672', 'groupId': 'OG000'}]}]}, {'title': 'Week 68 (n=69)', 'categories': [{'measurements': [{'value': '-9.232', 'spread': '0.824', 'groupId': 'OG000'}]}]}, {'title': 'Week 84 (n=62)', 'categories': [{'measurements': [{'value': '-10.18', 'spread': '0.848', 'groupId': 'OG000'}]}]}, {'title': 'Week 100 (n=52)', 'categories': [{'measurements': [{'value': '-10.06', 'spread': '1.031', 'groupId': 'OG000'}]}]}, {'title': 'Week 116 (n=47)', 'categories': [{'measurements': [{'value': '-10.19', 'spread': '1.183', 'groupId': 'OG000'}]}]}, {'title': 'Week 132 (n=31)', 'categories': [{'measurements': [{'value': '-11.68', 'spread': '1.554', 'groupId': 'OG000'}]}]}, {'title': 'Week 140 (n=25)', 'categories': [{'measurements': [{'value': '-13.12', 'spread': '1.586', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Weeks 18,26,40,52,68,84,100,116,132,140', 'description': 'The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values\n\nOf the 161 participants (80 in placebo and 81 in aripiprazole group), 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements).'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression (CGI) Improvement Score During Extension Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole', 'description': 'Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).'}], 'classes': [{'title': 'Week 12; n=158', 'categories': [{'measurements': [{'value': '2.873', 'spread': '0.089', 'groupId': 'OG000'}]}]}, {'title': 'Week 14; n=151', 'categories': [{'measurements': [{'value': '2.709', 'spread': '0.084', 'groupId': 'OG000'}]}]}, {'title': 'Week 18; n=152', 'categories': [{'measurements': [{'value': '2.625', 'spread': '0.091', 'groupId': 'OG000'}]}]}, {'title': 'Week 22; n=145', 'categories': [{'measurements': [{'value': '2.552', 'spread': '0.087', 'groupId': 'OG000'}]}]}, {'title': 'Week 26; n=140', 'categories': [{'measurements': [{'value': '2.707', 'spread': '0.113', 'groupId': 'OG000'}]}]}, {'title': 'Week 30; n=129', 'categories': [{'measurements': [{'value': '2.636', 'spread': '0.113', 'groupId': 'OG000'}]}]}, {'title': 'Week 34; n=121', 'categories': [{'measurements': [{'value': '2.554', 'spread': '0.106', 'groupId': 'OG000'}]}]}, {'title': 'Week 40; n=114', 'categories': [{'measurements': [{'value': '2.482', 'spread': '0.121', 'groupId': 'OG000'}]}]}, {'title': 'Week 46; n=103', 'categories': [{'measurements': [{'value': '2.592', 'spread': '0.130', 'groupId': 'OG000'}]}]}, {'title': 'Week 52; n=100', 'categories': [{'measurements': [{'value': '2.580', 'spread': '0.138', 'groupId': 'OG000'}]}]}, {'title': 'Week 68; n=70', 'categories': [{'measurements': [{'value': '2.514', 'spread': '0.155', 'groupId': 'OG000'}]}]}, {'title': 'Week 84; n=62', 'categories': [{'measurements': [{'value': '2.306', 'spread': '0.150', 'groupId': 'OG000'}]}]}, {'title': 'Week 100; n=53', 'categories': [{'measurements': [{'value': '2.660', 'spread': '0.196', 'groupId': 'OG000'}]}]}, {'title': 'Week 116; n=47', 'categories': [{'measurements': [{'value': '2.787', 'spread': '0.233', 'groupId': 'OG000'}]}]}, {'title': 'Week 132; n=36', 'categories': [{'measurements': [{'value': '3.028', 'spread': '0.289', 'groupId': 'OG000'}]}]}, {'title': 'Week 140; n=26', 'categories': [{'measurements': [{'value': '2.385', 'spread': '0.299', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 12, 14, 18, 22, 26, 30, 34, 40, 46, 52, 68, 84, 100, 116, 132, 140', 'description': "The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Improvement scale is a 7 point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.", 'unitOfMeasure': 'Units on Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values.\n\nOf the 161 participants, 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements).'}, {'type': 'SECONDARY', 'title': 'Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole', 'description': 'Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).'}], 'classes': [{'title': 'End of Acute Phase (Week 10); n=157', 'categories': [{'measurements': [{'value': '0.95', 'spread': '0.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 14; n=151', 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.12', 'groupId': 'OG000'}]}]}, {'title': 'Week 18; n=152', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.11', 'groupId': 'OG000'}]}]}, {'title': 'Week 22; n=145', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.13', 'groupId': 'OG000'}]}]}, {'title': 'Week 26; n=140', 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.13', 'groupId': 'OG000'}]}]}, {'title': 'Week 30; n=128', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.10', 'groupId': 'OG000'}]}]}, {'title': 'Week 34; n=121', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.15', 'groupId': 'OG000'}]}]}, {'title': 'Week 40; n=115', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 46; n=104', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.15', 'groupId': 'OG000'}]}]}, {'title': 'Week 52; n=100', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 68; n=70', 'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.17', 'groupId': 'OG000'}]}]}, {'title': 'Week 84; n=62', 'categories': [{'measurements': [{'value': '-0.24', 'spread': '0.17', 'groupId': 'OG000'}]}]}, {'title': 'Week 100; n=52', 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.15', 'groupId': 'OG000'}]}]}, {'title': 'Week 116; n=47', 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 140; n=15', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.20', 'groupId': 'OG000'}]}]}, {'title': 'Endpoint (LOCF data set); n=157', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of Acute Phase (Week 10), Weeks 14, 18, 22, 26, 30, 34, 40, 46, 52, 68, 84, 100, 116, 140', 'description': "AIMS is a rating scale that was designed to measure involuntary movements (tardive dyskinesia). The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body. These items are rated on a five-point scale of severity from 0-4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe).\n\nAIMS Total Score is from 0 to 28. A negative change score signifies improvement.", 'unitOfMeasure': 'Units on Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values.\n\nOf the 161 participants (80 in placebo and 81 in aripiprazole group), 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements).'}, {'type': 'SECONDARY', 'title': 'Change in Simpson-Angus Scale (SAS) Total Score During Extension Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole', 'description': 'Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).'}], 'classes': [{'title': 'End of Acute Phase (Week 10); n=153', 'categories': [{'measurements': [{'value': '14.34', 'spread': '0.40', 'groupId': 'OG000'}]}]}, {'title': 'Week 18; n=148', 'categories': [{'measurements': [{'value': '0.62', 'spread': '0.23', 'groupId': 'OG000'}]}]}, {'title': 'Week 26; n=132', 'categories': [{'measurements': [{'value': '1.24', 'spread': '0.31', 'groupId': 'OG000'}]}]}, {'title': 'Week 40; n=107', 'categories': [{'measurements': [{'value': '1.25', 'spread': '0.39', 'groupId': 'OG000'}]}]}, {'title': 'Week 52; n=95', 'categories': [{'measurements': [{'value': '1.14', 'spread': '0.40', 'groupId': 'OG000'}]}]}, {'title': 'Endpoint (LOCF data set); n=153', 'categories': [{'measurements': [{'value': '2.01', 'spread': '0.37', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of Acute Phase (Week 10), Weeks 18,26, 40, 52', 'description': 'The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50 (lower score=less severe). Negative change scores indicate improvement.', 'unitOfMeasure': 'Units on Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values.\n\nOf the 161 participants, 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements).'}, {'type': 'SECONDARY', 'title': 'Change in Barnes Global Clinical Assessment of Akathisia Score During Extension Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole', 'description': 'Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).'}], 'classes': [{'title': 'End of Acute Phase (Week 10); n=155', 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Week 18; n=151', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Week 26; n=139', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.04', 'groupId': 'OG000'}]}]}, {'title': 'Week 40; n=114', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.04', 'groupId': 'OG000'}]}]}, {'title': 'Week 52; n=99', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Endpoint (LOCF data set); n=155', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.03', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of Acute Phase (Week 10), Weeks 18,26, 40, 52', 'description': 'The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values.\n\nOf the 161 participants, 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements).'}, {'type': 'SECONDARY', 'title': 'Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events During Extension Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole', 'description': 'Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).'}], 'classes': [{'title': 'Dyskinesia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Muscle Rigidity', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Extrapyramidal Disorder', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Hypokinesia', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Tremor', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Akinesia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Bradykinesia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Parkinsonian Gait', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Muscle Twitching', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 11 to Week 140', 'description': 'Extrapyramidal symptoms (EPS) are various movement disorders such as acute dystonic reactions, pseudoparkinsonism, or akathisia', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All the 161 participants (80 in placebo and 81 in aripiprazole group)were included in the Extension Phase Safety Sample.'}, {'type': 'SECONDARY', 'title': 'Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Extension Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole', 'description': 'Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).'}], 'classes': [{'title': 'Death', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}, {'title': 'AE', 'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation due to AE', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 11 to Week 140', 'description': 'AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All the 161 participants (80 in placebo and 81 in aripiprazole group)were included in the Extension Phase Safety Sample.'}, {'type': 'SECONDARY', 'title': 'Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole', 'description': 'Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).'}], 'classes': [{'title': 'Increased Systolic BP, standing; n=159', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Decreased Systolic BP, standing; n=159', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Increased Systolic BP, supine; n=158', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Decreased Systolic BP, supine; n=158', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Decreased Systolic BP, sitting; n=45', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Increased Diastolic BP, standing; n=159', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Decreased Diastolic BP, standing; n=159', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Increased Diastolic BP, supine; n=158', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Decreased Diastolic BP, supine; n=158', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Decreased Diastolic BP, sitting; n=45', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Increased Heart rate, standing; n=159', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Decreased Heart rate, standing; n=159', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Increased Heart rate, supine; n=158', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Decreased Heart rate, supine; n=158', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Increased Weight; n=133', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Decreased Weight; n=133', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 11 to Week 140', 'description': 'Systolic BP: increase defined as ≥180 and a ≥20-mmHg increase from baseline (BL); decrease defined as ≤90 and a ≤20mmHg decrease from BL. Diastolic BP: increase defined as ≥105 and a ≥15mmHg decrease from BL, decrease defined as ≤50 and a ≤15mmHg decrease from BL. Heart rate: increase defined as ≥120 and ≥15bpm increase from bBL, decrease defined as ≤50 and ≤15bpm decrease from BL; Weight: increase defined as ≥7% from baseline, decrease defined as ≤7% decrease BL. Criteria for identifying PCS measurements based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All the 161 participants (80 in placebo and 81 in aripiprazole group) were included in the Extension Phase Safety Sample.'}, {'type': 'SECONDARY', 'title': 'Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole', 'description': 'Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).'}], 'classes': [{'title': 'Atrial Fibrillation; n=145', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Atrial Flutter; n=145', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Bradycardia; n=145', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Left Bundle Branch Block; n=145', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Myocardial Ischemia; n=145', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Old Infarction; n=145', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Right Bundle Branch Block; n=145', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Sinus Bradycardia; n=145', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Sinus Tachycardia; n=145', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Supraventricular Premature Beat; n=145', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Supraventricular Tachycardia; n=145', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Symmetrical T-wave Inversions; n=145', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Tachycardia; n=145', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Ventricular premature Beat; n=145', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 11 to Week 140', 'description': 'Bradycardia:Heart rate ≤50 bpm and ≥15 bpm decrease from baseline; Supraventricular premature beat: ≥2 per 10 seconds and any increase from baseline; 1st degree A-V Block: PR ≥0.20 seconds and increase of ≥0.05 second from baseline; Intraventricular conduction block:QRS ≥0.12 second and increase of ≥0.02 second from baseline; QTcB= ≥450 msec and ≥10% increase from baseline; QTcN =≥450 msec and ≥10% increase from baseline. All other events were not present at baseline but observed during the study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All the 161 participants (80 in placebo and 81 in aripiprazole group) were included in the Extension Phase Safety Sample.'}, {'type': 'SECONDARY', 'title': 'Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole', 'description': 'Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).'}], 'classes': [{'title': 'High Alanine aminotransferase; ≥ 41 U/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'High Aspartate aminotransferase; ≥ 38 U/L', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'High Alkaline phosphatase; ≥ 117 U/L', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'High Lactate dehydrogenase; >480 U/L', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'High Urea; >8.4 mmol/L', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'High Creatinine; ≥ 2.0 mg/dL', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'High Uric acid; >5.7 mg/dL', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'High Total Billirubin; > 1 mg/dL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'High Creatinine Kinase; ≥ 170 U/L', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'High Serum Glucose Fasting; >118 mg/dL', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'High Serum Glucose Non-fasting; >118 mg/dL', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'High Cholesterol Total; > 220mg/dL', 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}]}]}, {'title': 'High Serum Calcium; >10.2 mg/dL', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Low Serum Calcium; <8.6 mg/dL', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'High Serum Chloride; >108 mEq/L', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Low Serum Chloride; <96 mEq/L', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'High Serum Potassium; >5.1 mEq/L', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Low Serum Potassium; <3.3mEq/L', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'High Serum Sodium; > 145 mEq/L', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Low Serum Sodium; < 133 mEq/L', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Low Hematocrit; <37%', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Low Hemoglobin; < 12 g/dL', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'High Leukocyte count; > 10.8 x 10^3 c/uL', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Low Leukocyte count: < 4.8 x 10^3 c/uL', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'High Eosinophil count; > 5%', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'High Platelet count; >450 x 10^9 c/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Low Platelet count; < 150 x 10^9 c/L', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'High Urine Protein; ≥ 2-unit increase', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'High Urine Glucose; ≥ 2-unit increase', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 11 to Week 140', 'description': 'Criteria for identifying potentially clinically significant laboratory values were based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All the 161 participants (80 in placebo and 81 in aripiprazole group) were included in the Extension Phase Safety Sample.'}, {'type': 'SECONDARY', 'title': 'Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Treatment Beyond 140 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole', 'description': 'Treatment beyond 140 weeks: Dosed at 2-15 mg/day (flexible dosing).'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation due to AE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 140 to Week 328', 'description': 'AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in France who completed the 130-week open-label extension phase and continued beyond Week 140 were included in safety sample.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks)'}, {'id': 'FG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: Dosed at 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}], 'periods': [{'title': 'Acute Phase: Double-blind, 10 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '106'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Extension Phase: Week 10 to Week 130', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '80 out of the 84 participants entered extension phase. All were treated with open-label aripiprazole', 'groupId': 'FG000', 'numSubjects': '80'}, {'comment': 'Of the 88 participants, who completed Acute Phase, 81 opted to enter 130-week extension phase', 'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '56'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Participant Unreliability', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}, {'title': 'On Study Beyond Week 140', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': '9 participants in France who showed improvement at Week 140 continued treatment beyond 140 weeks', 'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': '232 participants were enrolled, 24 were not randomized (baseline failures).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Acute Phase: 0 mg, Once daily (10 Weeks)'}, {'id': 'BG001', 'title': 'Aripiprazole', 'description': 'Acute Phase: Dosed at 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '82.0', 'groupId': 'BG000', 'lowerLimit': '59', 'upperLimit': '99'}, {'value': '81.0', 'groupId': 'BG001', 'lowerLimit': '56', 'upperLimit': '95'}, {'value': '81.0', 'groupId': 'BG002', 'lowerLimit': '56', 'upperLimit': '99'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Asian/ Pacific Islander', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '58.8', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '102'}, {'value': '59.0', 'groupId': 'BG001', 'lowerLimit': '35', 'upperLimit': '100'}, {'value': '59.0', 'groupId': 'BG002', 'lowerLimit': '33', 'upperLimit': '102'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 232}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-07', 'studyFirstSubmitDate': '2011-09-02', 'resultsFirstSubmitDate': '2012-02-01', 'studyFirstSubmitQcDate': '2011-09-20', 'lastUpdatePostDateStruct': {'date': '2013-12-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-02-01', 'studyFirstPostDateStruct': {'date': '2011-09-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 10 in Acute Phase', 'timeFrame': 'Baseline (Day 0), Week 10', 'description': 'The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, and 8', 'description': 'The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.'}, {'measure': 'Change From Baseline in NPI Total Score in Acute Phase', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Total Score is calculated by adding the Individual Item Scores for all 12 domains, to yield a possible NPI Total Score of 0 to 144. Lower score=less severity. A negative change score from baseline indicates improvement.'}, {'measure': 'Participants Who Demonstrated a ≥ 50% Decrease From Baseline to Endpoint in the NPI Psychosis Subscale Score in Acute Phase', 'timeFrame': 'Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.'}, {'measure': 'Participants Who Demonstrated a ≥ 50% Decrease From Baseline in the Total NPI Score in Acute Phase', 'timeFrame': 'Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Total Score is calculated by adding the Individual Item Scores for all 12 domains, to yield a possible NPI Total Score of 0 to 144. Lower score=less severity. A negative change score from baseline indicates improvement.'}, {'measure': 'Change From Baseline in NPI Psychosis Subscale Caregiver Distress Score in Acute Phase', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale:0=not at all distressing to 5=extremely distressing). The NPI Psychosis Subscale Caregiver Distress Score is calculated by adding Individual Item Scores for the domains of Delusions and Hallucinations, to yield a possible total score of 0 to 10. Lower score=less severity. A negative change score from baseline=improvement.'}, {'measure': 'Change From Baseline in NPI Total Caregiver Distress Score in Acute Phase', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The total NPI Caregiver Distress Score is calculated by adding the 12 Caregiver Distress Individual Item Scores, to yield a possible total score of 0 to 60. Lower score=less severity. A negative change score from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score in Acute Phase', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': "The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Severity scale is a 7-point scale that requires the clinician to rate the severity of the illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. The assessment is based on severity of mental illness at the time of rating, 0=not assessed, 1=normal, 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill."}, {'measure': 'CGI Improvement Score in Acute Phase', 'timeFrame': 'Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': "The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Improvement scale is a 7 point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse."}, {'measure': 'Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score in Acute Phase', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The BPRS is designed to measure clinical change in participants and is used as a global measure of psychopathology. The BPRS includes 18 items with items devoted to hallucinatory behavior, suspiciousness, unusual thought content, etc. BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126.\n\nA negative change score signifies improvement.'}, {'measure': 'Change From Baseline in Mini Mental State Examination (MMSE) Total Score in Acute Phase', 'timeFrame': 'Baseline (Day 0), Week 10', 'description': 'The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language). It is a 19 item scale, the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline.'}, {'measure': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Delusions', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.'}, {'measure': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Hallucinations', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.'}, {'measure': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Agitation/Aggression', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.'}, {'measure': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Depression/Dysphoria', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.'}, {'measure': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Anxiety', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.'}, {'measure': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Apathy/Indifference', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.'}, {'measure': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Elation/Euphoria', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.'}, {'measure': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Disinhibition', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.'}, {'measure': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Irritability/Lability', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.'}, {'measure': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Aberrant Motor Behavior', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.'}, {'measure': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Appetite/Eating Behaviors', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.'}, {'measure': 'Change From Baseline in NPI Individual Item Scores in Acute Phase: Sleep', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Simpson-Angus Scale (SAS) Total Score in Acute Phase', 'timeFrame': 'Baseline (Day 0), Weeks 2, 4, and 10', 'description': 'The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50.(lower score=less severe). Negative change scores indicate improvement.'}, {'measure': 'Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score in Acute Phase', 'timeFrame': 'Baseline (Day 0), Weeks 2, 4, 8, and 10', 'description': "The Abnormal Involuntary Movement Scale (AIMS) is a rating scale that was designed to measure involuntary movements (tardive dyskinesia). The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body. These items are rated on a five-point scale of severity from 0-4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe).\n\nAIMS Total Score is from 0 to 28. A negative change score signifies improvement."}, {'measure': 'Change From Baseline in Barnes Global Clinical Assessment of Akathisia in Acute Phase', 'timeFrame': 'Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10', 'description': 'The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.'}, {'measure': 'Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events in Acute Phase', 'timeFrame': 'Week 1 to week 10', 'description': 'Extrapyramidal symptoms (EPS) are various movement disorders such as acute dystonic reactions, pseudoparkinsonism, or akathisia'}, {'measure': 'Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs in Acute Phase', 'timeFrame': 'Week 1 to week 10', 'description': 'AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.'}, {'measure': 'Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase', 'timeFrame': 'Week 1 to Week 10', 'description': 'Criteria for identifying potentially clinically significant laboratory values were based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products. Normal ranges are local lab data and vary according to the site. M=male, F=female. Criteria for hematocrit also includes a 3 point shift from baseline.'}, {'measure': 'Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase', 'timeFrame': 'Week 1 to week 10', 'description': 'Systolic BP: increase defined as ≥180 and a ≥20-mmHg increase from baseline (BL); decrease defined as ≤90 and a ≥20mmHg decrease from BL. Diastolic BP: increase defined as ≥105 and a ≥15mmHg decrease from BL, decrease defined as ≤50 and a ≥15mmHg decrease from BL. Heart rate: increase defined as ≥120 and ≥15bpm increase from BL, decrease defined as ≤50 and ≥15bpm decrease from BL; Weight: increase defined as ≥7% from BL, decrease defined as ≤7% decrease BL. Criteria for identifying PCS measurements are based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products'}, {'measure': 'Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase', 'timeFrame': 'Week 1 to Week 10', 'description': 'Bradycardia:Heart rate ≤50 bpm and ≥15 bpm decrease from baseline; Supraventricular premature beat: ≥2 per 10 seconds and any increase from baseline; 1st degree A-V Block: PR ≥0.20 seconds and increase of ≥0.05 second from baseline; Intraventricular conduction block:QRS ≥0.12 second and increase of ≥0.02 second from baseline; QTcB= ≥450 msec and ≥10% increase from baseline; QTcN =≥450 msec and ≥10% increase from baseline. All other events were not present at baseline but observed during the study. Inc=increase'}, {'measure': 'Change in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score From Baseline During Extension Phase', 'timeFrame': 'Baseline (Day 0), Weeks 18,26,40,52,68,84,100,116,132,140', 'description': 'The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.'}, {'measure': 'Clinical Global Impression (CGI) Improvement Score During Extension Phase', 'timeFrame': 'Weeks 12, 14, 18, 22, 26, 30, 34, 40, 46, 52, 68, 84, 100, 116, 132, 140', 'description': "The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Improvement scale is a 7 point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse."}, {'measure': 'Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase', 'timeFrame': 'End of Acute Phase (Week 10), Weeks 14, 18, 22, 26, 30, 34, 40, 46, 52, 68, 84, 100, 116, 140', 'description': "AIMS is a rating scale that was designed to measure involuntary movements (tardive dyskinesia). The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body. These items are rated on a five-point scale of severity from 0-4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe).\n\nAIMS Total Score is from 0 to 28. A negative change score signifies improvement."}, {'measure': 'Change in Simpson-Angus Scale (SAS) Total Score During Extension Phase', 'timeFrame': 'End of Acute Phase (Week 10), Weeks 18,26, 40, 52', 'description': 'The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50 (lower score=less severe). Negative change scores indicate improvement.'}, {'measure': 'Change in Barnes Global Clinical Assessment of Akathisia Score During Extension Phase', 'timeFrame': 'End of Acute Phase (Week 10), Weeks 18,26, 40, 52', 'description': 'The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.'}, {'measure': 'Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events During Extension Phase', 'timeFrame': 'Week 11 to Week 140', 'description': 'Extrapyramidal symptoms (EPS) are various movement disorders such as acute dystonic reactions, pseudoparkinsonism, or akathisia'}, {'measure': 'Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Extension Phase', 'timeFrame': 'Week 11 to Week 140', 'description': 'AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.'}, {'measure': 'Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase', 'timeFrame': 'Week 11 to Week 140', 'description': 'Systolic BP: increase defined as ≥180 and a ≥20-mmHg increase from baseline (BL); decrease defined as ≤90 and a ≤20mmHg decrease from BL. Diastolic BP: increase defined as ≥105 and a ≥15mmHg decrease from BL, decrease defined as ≤50 and a ≤15mmHg decrease from BL. Heart rate: increase defined as ≥120 and ≥15bpm increase from bBL, decrease defined as ≤50 and ≤15bpm decrease from BL; Weight: increase defined as ≥7% from baseline, decrease defined as ≤7% decrease BL. Criteria for identifying PCS measurements based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products'}, {'measure': 'Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase', 'timeFrame': 'Week 11 to Week 140', 'description': 'Bradycardia:Heart rate ≤50 bpm and ≥15 bpm decrease from baseline; Supraventricular premature beat: ≥2 per 10 seconds and any increase from baseline; 1st degree A-V Block: PR ≥0.20 seconds and increase of ≥0.05 second from baseline; Intraventricular conduction block:QRS ≥0.12 second and increase of ≥0.02 second from baseline; QTcB= ≥450 msec and ≥10% increase from baseline; QTcN =≥450 msec and ≥10% increase from baseline. All other events were not present at baseline but observed during the study'}, {'measure': 'Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase', 'timeFrame': 'Week 11 to Week 140', 'description': 'Criteria for identifying potentially clinically significant laboratory values were based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products.'}, {'measure': 'Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Treatment Beyond 140 Weeks', 'timeFrame': 'Week 140 to Week 328', 'description': 'AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dementia, Alzheimer Type']}, 'descriptionModule': {'briefSummary': "The primary objective of the study is to compare the efficacy of aripiprazole with placebo in patients with psychosis associated with Alzheimer's dementia.", 'detailedDescription': "Open label Extension Phase: The 130-week Extension Phase was conducted to provide information regarding long-term safety and efficacy of aripiprazole in participants who were diagnosed at the onset of the Acute Phase with psychotic symptoms associated with dementia of the Alzheimer's type who responded to treatment in the 10-week Acute Phase of this study.\n\nTreatment beyond 140 week: A country-specific amendment for France, allowed participants treated with aripiprazole who, according to the investigator's opinion, showed improvement at the Week 140 visit to continue treatment beyond 140 weeks. The termination was to be determined by clinical benefit to he participant.\n\nStudy design:\n\nAcute Phase: Randomized, double-blind, placebo-controlled, flexible-dose, parallel-group study.\n\nExtension Phase: Open label; flexible-dose."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Non-institutionalized patients with a diagnosis of Alzheimer's disease as defined by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria with symptoms of delusions or hallucinations, which have been present, at least intermittently for one month or longer\n* Mini Mental State Examination (MMSE) score of 6 to 24 points\n* Patients capable of self locomotion or locomotion with the aid of an assistive device\n* Patients with an identified caregiver or proxy\n\nFor Extension Phase:\n\nEligible patients were males and females who had completed the 10-week Acute Phase in either treatment group; had a Week 10 Total Score of ≥ 6 on the NPI; and were, in the judgment of the investigator, deemed suitable for participation in the long-term trial.\n\nTreatment beyond 140 weeks:\n\nAll subjects who completed the extension phase of CN138-006 in any French Investigational Site may be considered eligible for entry until they are no longer receiving clinical benefit, per the investigator's judgment\n\nExclusion Criteria:\n\n* Patients with an Axis I (DSM IV) diagnosis of:\n\n * delirium\n * amnestic disorders\n * bipolar disorder\n * schizophrenia or schizoaffective disorder\n * mood disorder with psychotic features\n* Patients with reversible causes of dementia\n* Patients with psychotic symptoms continuously present since prior to the onset of the symptoms of dementia\n* Patients with psychotic symptoms that are better accounted for by another general medical condition or by direct physiological effects of a substance\n* Patients with a current major depressive episode with psychotic symptoms of hallucinations or delusions\n* Patients with a diagnosis of dementia related to infection with the human immunodeficiency virus\n* Patients with substance-induced persistent dementia\n* Patients with dementia due to vascular causes, multi-infarct, head trauma, Pick's disease, Parkinson's disease, frontal or temporal dementia, Lewy body dementia, or any specific non-Alzheimer's type dementia\n* Patients with seizure disorders\n* Patients who have been refractory to neuroleptics used to treat psychotic symptoms in the past when treated for an adequate period with a therapeutic dose, unless permission is obtained from Bristol-Myers Squibb\n* Patients who have met DSM-IV criteria for any significant substance use disorder within the 6 months prior to the start of screening"}, 'identificationModule': {'nctId': 'NCT01438060', 'briefTitle': "Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type", 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'officialTitle': "A Multicenter, Randomized, Double-Blind, Placebo Controlled Flexible Dose Study of Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type", 'orgStudyIdInfo': {'id': 'CN138-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aripiprazole (BMS-337039)', 'description': 'Double blind Acute Phase (Week 1 to Week 10), Open label Extension Phase (Week 11 to Week 140)', 'interventionNames': ['Drug: Aripiprazole (BMS-337039)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Double blind Acute Phase (Week 1 to Week 10)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Aripiprazole (BMS-337039)', 'type': 'DRUG', 'description': 'Acute Phase: Oral, Tablets (1 and 5 mg), Week 1-2: 2 mg, Week 3-4: 2 - 5 mg, Week 5-6: 2 - 10 mg, Weeks 7-10: 2 - 15 mg, Once daily, 10 weeks\n\nExtension Phase: Oral, Tablets (1 and 5 mg), Week 11: 2 mg, Weeks 12-13: 2 - 5 mg, Weeks 14-15: 2 - 10 mg, Weeks 16-140: 2 - 15 mg, Once daily, 130 weeks', 'armGroupLabels': ['Aripiprazole (BMS-337039)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Acute Phase: Oral, Tablets, 0 mg, Once daily, 10 Weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Development & Commercialization, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Otsuka America Pharmaceutical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}