Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT00239356
Status:
COMPLETED
Last Update Posted:
2014-12-19
First Post:
2005-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Aripiprazole for Schizophrenia Outpatients Completing BMS Clinical Trials
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic 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': 'Bristol-Myers Squibb 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}}, 'adverseEventsModule': {'timeFrame': "AEs were collected up to the participant's last visit. SAEs that occurred within 4 weeks after study discontinuation were included.", 'description': 'Participants were to continue to receive study drug until: treatment intolerance, voluntary withdrawal, death, lost to follow up, no longer receiving benefit, the study drug was otherwise available through marketed means, the development of the study drug was terminated by the sponsor, or until 01 November 2012, whichever came first.', 'eventGroups': [{'id': 'EG000', 'title': 'Bipolar I Disorder 5 - 30 mg QD', 'description': 'Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.', 'otherNumAtRisk': 20, 'otherNumAffected': 10, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Schizophrenia 10 - 30 mg QD', 'description': 'Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.', 'otherNumAtRisk': 97, 'otherNumAffected': 22, 'seriousNumAtRisk': 97, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Treatment noncompliance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Alcoholism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Inadequate housing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Psychosocial support', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 - 30 mg Once Daily (QD)', 'description': 'Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.'}, {'id': 'OG001', 'title': 'Aripiprazole 5 - 30 mg QD', 'description': 'Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.6', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (N=67, 15)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.35', 'groupId': 'OG001'}]}]}, {'title': 'Week 108 (N=46,15)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.35', 'groupId': 'OG001'}]}]}, {'title': 'Week 156 (N=26,12)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.29', 'groupId': 'OG001'}]}]}, {'title': 'Week 212 (N=21,0)', 'categories': [{'measurements': [{'value': '2.1', 'spread': '0.96', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'All participants had dropped out or completed study in the Bipolar Disorder arm.', 'groupId': 'OG001'}]}]}, {'title': 'Week 260 (N=8,0)', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.13', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'All participants had dropped out or completed study in the Bipolar Disorder arm.', 'groupId': 'OG001'}]}]}, {'title': 'Week 316 (N=5,0)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.14', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'All participants had dropped out or completed study in the Bipolar Disorder arm.', 'groupId': 'OG001'}]}]}, {'title': 'Week 348 (N=5,0)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.14', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'All participants had dropped out or completed study in the Bipolar Disorder arm.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 348', 'description': 'Baseline is Day 1 of the study, prior to first dose. CGI-S is a questionnaire completed by the clinician which evaluates the severity of mental illness of a participant at a specific point in time. It consists of 7 categories with the lower categories indicating less illness and the higher numbered categories indicating greater severity of illness: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3= mildly ill; 4=moderately ill; 5= markedly ill; 6=severely ill; 7=among the most extremely ill.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - all participants who received at least one dose of drug. N=number of participants who were analyzed at each specific time point. Baseline N=97, 20 for first and second arms, respectively.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to an AE - Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 - 30 mg Once Daily (QD)', 'description': 'Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.'}, {'id': 'OG001', 'title': 'Aripiprazole 5 - 30 mg QD', 'description': 'Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.'}], 'classes': [{'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Discontinuations due to AEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 348', 'description': 'AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants with at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Mean Exposure to Aripiprazole at Days 541 to 630, Days 721 to 810 and Days 1081 to 1170 - Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 - 30 mg Once Daily (QD)', 'description': 'Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.'}, {'id': 'OG001', 'title': 'Aripiprazole 5 - 30 mg QD', 'description': 'Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.'}], 'classes': [{'title': 'Days 541 to 630 (N=57, 17)', 'categories': [{'measurements': [{'value': '20.25', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '30.0'}, {'value': '13.53', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '30.0'}]}]}, {'title': 'Days 721 to 810 (N=44, 15)', 'categories': [{'measurements': [{'value': '20.55', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '30.0'}, {'value': '13.67', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '30.0'}]}]}, {'title': 'Days 1081 to 1170 (N=27, 12)', 'categories': [{'measurements': [{'value': '23.20', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '60.0'}, {'value': '14.7', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '30.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Day 1170', 'description': 'Mean exposure is mean number of milligrams per day (mg/day) of aripiprazole administered to the participants.', 'unitOfMeasure': 'mg/day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'N=number of participants receiving drug at Days indicated.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 - 30 mg Once Daily (QD)', 'description': 'Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.'}, {'id': 'OG001', 'title': 'Aripiprazole 5 - 30 mg QD', 'description': 'Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.'}], 'classes': [{'title': 'Total Bilirubin (N=78, 18)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Blood urea nitrogen (N=37, 18)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Calcium (N=76, 18)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serum chloride (N=62, 17)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol HDL Fasting (N=44, 13)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol LDL Fasting (N=47, 13)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Cholesterol Fasting (N=55, 16)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase (N=64, 18)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine (N=81, 18)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, Fasting serum (N=61, 15)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, serum (N=37, 2)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Prolactin (N=63, 18)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Sodium, serum (N=76, 17)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides Fasting (N=59, 16)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid (N=71, 17)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to end of study (Week 348)', 'description': 'Clinically relevant abnormalities: greater than, equal to (\\>=); less than, equal to (\\<=). Upper limits of normal (ULN). milligram per deciliter (mg/dL); milliequivalent per liter (mEq/L); nanograms per milliliter (ng/mL);outside of normal range inclusive (): alanine transaminase (ALT\\>= 3\\*ULN; aspartate aminotransferase (AST \\>=3\\*ULN; alkaline phosphatase \\>=3\\*ULN; total bilirubin \\>= 2.0 mg/dL; blood urea nitrogen \\>= 30mg/dL; calcium (8.40 - 9.90 mg/dL); chloride (85.00 - 108.00 mEq/L); total cholesterol (140.0 - 200.0 mg/dL); cholesterol high density (HDL) and low density (LDL) lipoprotein (39.0 - 116.0 mg/dL); creatine kinase (15.0 - 170.0 U/L); creatinine \\>=2.0 mg/dL; prolactin (3.00 - 29.00 ng/mL); sodium (136.0 - 144.0 mEq/L); Glucose fasting (70.0 - 110.0 mg/dL); triglycerides (58.0 - 164.0 mg/dL; uric acid male \\>= 10.5, female \\>= 8.5mg/dL. Baseline is Day 1 of the study, prior to study drug administration.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants with at least 1 dose of study drug. Number of participant analyzed is given as N in each category of laboratory test.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Potentially Clinically Relevant Hematology Laboratory Abnormalities During Treatment - Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 - 30 mg Once Daily (QD)', 'description': 'Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.'}, {'id': 'OG001', 'title': 'Aripiprazole 5 - 30 mg QD', 'description': 'Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.'}], 'classes': [{'title': 'Eosinophils, relative (N=80, 18)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit (N=80, 16)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin (N=81, 18)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes (N=81, 18)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to end of study (Week 348)', 'description': 'Clinically relevant laboratory abnormality: Hemoglobin male \\<= 11.5 g/dL; female \\<= 9.5 g/dL. Hematocrit male \\<= 37 and 3 point decrease from baseline (BL); female \\<=32 and 3 point decrease from BL. Leukocytes \\<= 2800 mm\\^3 or \\>= 16000 mm\\^3; eosinophils \\>=10%. Baseline is Day 1 of the study, prior to study drug administration.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants with at least 1 dose of study drug. Number of participant analyzed is given as N in each category of laboratory test.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Potentially Clinically Relevant Vital Sign Abnormality During Treatment - Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 - 30 mg Once Daily (QD)', 'description': 'Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.'}, {'id': 'OG001', 'title': 'Aripiprazole 5 - 30 mg QD', 'description': 'Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.'}], 'classes': [{'title': 'Standing Systolic decrease (N=87,18)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Standing Diastolic increase (N=87,18)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Supine Diastolic increase (N=79,20)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sitting Diastolic increase (N=61,5)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Standing Heart Rate increase (N=87,18)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Orthostatic Hypotension (N=78, 18)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to end of study (Week 348)', 'description': "Vital signs include standing, sitting and supine systolic and diastolic blood pressure, measured in millimeters of mercury (mmHg) and standing, sitting and supine heart rate, measured in beats per minute. Baseline (BL) is Day 1 of the study, prior to study drug administration. Criteria for identifying vital sign values as clinically relevant: Systolic blood pressure (criterion value=90-180 mmHg) change relative to baseline: increase of greater than, equal to (\\>=) 20; decrease of \\>= 20 mmHg. Diastolic blood pressure (criterion value=50 - 105 mmHg) change relative to baseline: increase of \\>= 15; decrease of \\>= 15 mmHg. Heart rate (criterion value=50-120bpm) change relative to baseline: increase \\>=15; decreased \\>= 15 mmHg. To be clinically significantly abnormal: value must meet the criterion value and also represent a change from the participant's pre-treatment value of at least the magnitude shown in the change relative to baseline.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants with at least 1 dose of study drug. Number of participants analyzed is given as N in each vital sign parameter and includes those treated participants with vital sign measurements.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 - 30 mg Once Daily (QD)', 'description': 'Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.'}, {'id': 'OG001', 'title': 'Aripiprazole 5 - 30 mg QD', 'description': 'Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.'}], 'classes': [{'title': 'Tachycardia (N=85, 16)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Bradycardia (N=85, 16)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Sinus Tachycardia (N=85, 16)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Sinus Bradycardia (N=85, 16)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'First degree A-V Block (N=85, 16)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'RBB Block (N=85, 16)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pre-excitation syndrome (N=85, 16)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other intraventricular Block (N=85, 16)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Myocardial Ischemia (N=85, 16)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QTcB (N=83, 16)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'QTcF (N=83, 16)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to end of study (Week 348', 'description': "Potentially clinically relevant abnormality or change relative to baseline: sinus tachycardia: \\>= 120 beats per minute (bpm) and increased \\>= 15 bpm; sinus bradycardia: \\<= 50 bpm and decrease \\>= 15 bpm; supraventricular tachycardia, ventricular tachycardia, atrial fibrillation, atrial flutter: not present to present. First degree atrioventricular (A-V) block: PR interval(beginner of P wave to beginning of complex of Q, R, and S waves) \\>= 0.20 seconds (sec) and increase \\>= 0.05 sec; second and third degree A-V block, right bundle branch block (RBB) block, left bundle branch block (LBB) block: not present to present; other intraventricular block: QRS (complex of Q, R and S waves) \\>= 0.12 sec and increase \\>= 0.02 sec. Myocardial ischemia not present to present. QT interval with Bazett's correction (QTcB) or Fridericia's correction (QTcF) \\>= 450 milliseconds (msec) and elevation of 10% over baseline.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants with at least 1 dose of study drug. Number of participants analyzed is given as N in each ECG parameter and includes those treated participants with ECG measurements.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aripiprazole 10 - 30 mg Once Daily (QD)', 'description': 'Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.'}, {'id': 'FG001', 'title': 'Aripiprazole 5 - 30 mg QD', 'description': 'Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'poor/non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Administrative reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Drug available on market', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This study continued to provide aripiprazole post-study to schizophrenic and bipolar I disorder outpatients who had received aripiprazole on other Bristol-Myers Squibb Company (BMS)-sponsored clinical trials.', 'preAssignmentDetails': '119 enrolled, 117 treated. Reason(s) for not treated: 2 participants withdrew consent prior to treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aripiprazole 10 - 30 mg Once Daily (QD)', 'description': 'Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.'}, {'id': 'BG001', 'title': 'Aripiprazole 5 - 30 mg QD', 'description': 'Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.3', 'spread': '11.66', 'groupId': 'BG000'}, {'value': '40.3', 'spread': '11.78', 'groupId': 'BG001'}, {'value': '39.5', 'spread': '11.63', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Croatia', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Clinical Global Impression (CGI) Severity', 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '0.97', 'groupId': 'BG000'}, {'value': '1.0', 'spread': '0.00', 'groupId': 'BG001'}, {'value': '2.3', 'spread': '1.06', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Clinical Global Impression (CGI) Severity Scores are measured on a scale of 1 to 7, with 1 being least severe and 7 being the most severe.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All treated participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-04', 'studyFirstSubmitDate': '2005-10-13', 'resultsFirstSubmitDate': '2013-11-05', 'studyFirstSubmitQcDate': '2005-10-13', 'lastUpdatePostDateStruct': {'date': '2014-12-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-22', 'studyFirstPostDateStruct': {'date': '2005-10-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population.', 'timeFrame': 'Baseline to Week 348', 'description': 'Baseline is Day 1 of the study, prior to first dose. CGI-S is a questionnaire completed by the clinician which evaluates the severity of mental illness of a participant at a specific point in time. It consists of 7 categories with the lower categories indicating less illness and the higher numbered categories indicating greater severity of illness: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3= mildly ill; 4=moderately ill; 5= markedly ill; 6=severely ill; 7=among the most extremely ill.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to an AE - Safety Population', 'timeFrame': 'Baseline to Week 348', 'description': 'AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.'}, {'measure': 'Mean Exposure to Aripiprazole at Days 541 to 630, Days 721 to 810 and Days 1081 to 1170 - Safety Population', 'timeFrame': 'Day 1 to Day 1170', 'description': 'Mean exposure is mean number of milligrams per day (mg/day) of aripiprazole administered to the participants.'}, {'measure': 'Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population', 'timeFrame': 'Baseline to end of study (Week 348)', 'description': 'Clinically relevant abnormalities: greater than, equal to (\\>=); less than, equal to (\\<=). Upper limits of normal (ULN). milligram per deciliter (mg/dL); milliequivalent per liter (mEq/L); nanograms per milliliter (ng/mL);outside of normal range inclusive (): alanine transaminase (ALT\\>= 3\\*ULN; aspartate aminotransferase (AST \\>=3\\*ULN; alkaline phosphatase \\>=3\\*ULN; total bilirubin \\>= 2.0 mg/dL; blood urea nitrogen \\>= 30mg/dL; calcium (8.40 - 9.90 mg/dL); chloride (85.00 - 108.00 mEq/L); total cholesterol (140.0 - 200.0 mg/dL); cholesterol high density (HDL) and low density (LDL) lipoprotein (39.0 - 116.0 mg/dL); creatine kinase (15.0 - 170.0 U/L); creatinine \\>=2.0 mg/dL; prolactin (3.00 - 29.00 ng/mL); sodium (136.0 - 144.0 mEq/L); Glucose fasting (70.0 - 110.0 mg/dL); triglycerides (58.0 - 164.0 mg/dL; uric acid male \\>= 10.5, female \\>= 8.5mg/dL. Baseline is Day 1 of the study, prior to study drug administration.'}, {'measure': 'Number of Participants With Potentially Clinically Relevant Hematology Laboratory Abnormalities During Treatment - Safety Population', 'timeFrame': 'Baseline to end of study (Week 348)', 'description': 'Clinically relevant laboratory abnormality: Hemoglobin male \\<= 11.5 g/dL; female \\<= 9.5 g/dL. Hematocrit male \\<= 37 and 3 point decrease from baseline (BL); female \\<=32 and 3 point decrease from BL. Leukocytes \\<= 2800 mm\\^3 or \\>= 16000 mm\\^3; eosinophils \\>=10%. Baseline is Day 1 of the study, prior to study drug administration.'}, {'measure': 'Number of Participants With Potentially Clinically Relevant Vital Sign Abnormality During Treatment - Safety Population', 'timeFrame': 'Baseline to end of study (Week 348)', 'description': "Vital signs include standing, sitting and supine systolic and diastolic blood pressure, measured in millimeters of mercury (mmHg) and standing, sitting and supine heart rate, measured in beats per minute. Baseline (BL) is Day 1 of the study, prior to study drug administration. Criteria for identifying vital sign values as clinically relevant: Systolic blood pressure (criterion value=90-180 mmHg) change relative to baseline: increase of greater than, equal to (\\>=) 20; decrease of \\>= 20 mmHg. Diastolic blood pressure (criterion value=50 - 105 mmHg) change relative to baseline: increase of \\>= 15; decrease of \\>= 15 mmHg. Heart rate (criterion value=50-120bpm) change relative to baseline: increase \\>=15; decreased \\>= 15 mmHg. To be clinically significantly abnormal: value must meet the criterion value and also represent a change from the participant's pre-treatment value of at least the magnitude shown in the change relative to baseline."}, {'measure': 'Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population', 'timeFrame': 'Baseline to end of study (Week 348', 'description': "Potentially clinically relevant abnormality or change relative to baseline: sinus tachycardia: \\>= 120 beats per minute (bpm) and increased \\>= 15 bpm; sinus bradycardia: \\<= 50 bpm and decrease \\>= 15 bpm; supraventricular tachycardia, ventricular tachycardia, atrial fibrillation, atrial flutter: not present to present. First degree atrioventricular (A-V) block: PR interval(beginner of P wave to beginning of complex of Q, R, and S waves) \\>= 0.20 seconds (sec) and increase \\>= 0.05 sec; second and third degree A-V block, right bundle branch block (RBB) block, left bundle branch block (LBB) block: not present to present; other intraventricular block: QRS (complex of Q, R and S waves) \\>= 0.12 sec and increase \\>= 0.02 sec. Myocardial ischemia not present to present. QT interval with Bazett's correction (QTcB) or Fridericia's correction (QTcF) \\>= 450 milliseconds (msec) and elevation of 10% over baseline."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to provide aripiprazole to schizophrenic outpatients and Community Treated Patients who are currently receiving aripiprazole therapy on another BMS sponsored clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently receiving aripiprazole at time of screening\n* Men and women ages 18 to 70\n\nExclusion Criteria:\n\n* All patients previously discontinued from an aripiprazole study for any reason\n* Active alcohol or substance abuse\n* Patients who represent a significant risk of committing suicide\n* Patients with clinically significant abnormal laboratory test results, vital signs or ECG findings'}, 'identificationModule': {'nctId': 'NCT00239356', 'briefTitle': 'Aripiprazole for Schizophrenia Outpatients Completing BMS Clinical Trials', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'officialTitle': 'Aripiprazole (BMS-337039) for Outpatients With Schizophrenia Completing Aripiprazole Clinical Trials: A Non-Comparative Rollover Protocol', 'orgStudyIdInfo': {'id': 'CN138-112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AI', 'interventionNames': ['Drug: Aripiprazole']}], 'interventions': [{'name': 'Aripiprazole', 'type': 'DRUG', 'otherNames': ['Abilify', 'BMS-337039'], 'description': 'Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country', 'armGroupLabels': ['AI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'city': 'Rijeka', 'country': 'Croatia', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.32673, 'lon': 14.44241}}, {'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Nantes Orvault', 'country': 'France', 'facility': 'Local Institution'}, {'city': 'Rennes', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Uzès', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 44.01251, 'lon': 4.41973}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Győr', 'country': 'Hungary', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.68333, 'lon': 17.63512}}, {'city': 'Vught', 'country': 'Netherlands', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.65333, 'lon': 5.2875}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Local Institution', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Local Institution', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Westdene', 'state': 'Free State', 'country': 'South Africa', 'facility': 'Local Institution'}, {'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Local Institution', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Local Institution', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Antrim', 'state': 'Antrim', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 54.7175, 'lon': -6.211}}], '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'}}}}