Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 10:58 PM
Study NCT ID:
NCT01412060
Status:
COMPLETED
Last Update Posted:
2018-07-06
First Post:
2011-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia
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': 'C533287', 'term': 'cariprazine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area Head', 'organization': 'Allergan'}, 'certainAgreement': {'otherDetails': 'All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]', 'description': 'Run-in Phase Safety Population: All randomized participants who received at least 1 dose of investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the open-label phase (OLP) of the study.\n\nDouble-blind Safety Population: All participants in the Randomized Population who took at least 1 dose of double-blind investigational product.\n\nAdverse events data was reported in periods as per the treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'Cariprazine - Open-label Phase', 'description': 'Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this 20 week Open-label Phase.', 'otherNumAtRisk': 765, 'deathsNumAtRisk': 765, 'otherNumAffected': 425, 'seriousNumAtRisk': 765, 'deathsNumAffected': 0, 'seriousNumAffected': 50}, {'id': 'EG001', 'title': 'Placebo - Double-blind Treatment Phase', 'description': 'Participants received placebo orally once a day for 26 to 72 weeks.', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 28, 'seriousNumAtRisk': 99, 'deathsNumAffected': 0, 'seriousNumAffected': 14}, {'id': 'EG002', 'title': 'Cariprazine - Double-blind Treatment Phase', 'description': 'Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks.', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 35, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 14}, {'id': 'EG003', 'title': 'Open-label - Safety Follow-up Phase', 'description': 'Participants received no treatment during the 4 weeks Safety Follow-up Phase.', 'otherNumAtRisk': 765, 'deathsNumAtRisk': 765, 'otherNumAffected': 0, 'seriousNumAtRisk': 765, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG004', 'title': 'Placebo - Safety Follow-up Phase', 'description': 'Participants received no treatment during the 4 weeks Safety Follow-up Phase.', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 0, 'seriousNumAtRisk': 99, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Cariprazine - Safety Follow-up Phase', 'description': 'Participants received no treatment during the 4 weeks Safety Follow-up Phase.', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 0, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 148}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Extrapyramidal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}], 'seriousEvents': [{'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Suicidal ideation', 'stats': 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'Social stay hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Drug abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Extrapyramidal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Foreign body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Intentional product misuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Surgical 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99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Psychotic behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 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'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Victim of crime', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Drug ineffective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Multiple injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Middle ear effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Tachycardia paroxysmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 765, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time From Baseline to the First Symptom Relapse During the Double-blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 26 to 72 weeks. Placebo: Placebo was supplied in capsules.'}, {'id': 'OG001', 'title': 'Cariprazine', 'description': 'Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks. Cariprazine: Cariprazine was supplied in capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000', 'lowerLimit': '44', 'upperLimit': '151'}, {'value': '224', 'comment': 'The upper limit of the confidence interval could not be calculated due to insufficient number of events.', 'groupId': 'OG001', 'lowerLimit': '99', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '0.28', 'ciUpperLimit': '0.73', 'estimateComment': 'Hazard ratio (cariprazine 3-9 mg vs placebo) is based on Cox proportional hazards regression model, with treatment group as an explanatory variable.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 34 Weeks and Bi-Weekly thereafter until Week 92', 'description': "Relapse was defined as meeting ≥1 of the following criteria:1-Hospitalization due to worsening of condition;2-increase in Positive and Negative Syndrome Scale(PANSS) total score by ≥30% for participants,scored ≥50 or a ≥10-point increase for participants,scored \\<50 at randomization;3-increase in Clinical Global Impressions-Severity(CGI-S) score by ≥2 points at Week 20;4-deliberate self-injury or aggressive behaviour;5-suicidal/homicidal ideation judged clinically significant by Investigator;6-score of \\>4 on 1 or more of following PANSS items:P1,P2,P3,P6,P7,G8 or G14. Second assessment not performed based on Investigator discretion.\n\nPANSS is 30-item rating scale. Each item scored on 7-point scale. Total score ranges from 30 to 210. Lower score indicates fewer schizophrenic symptoms. CGI-S is 7-point scale,measures severity of participant's illness in comparison with others with same diagnosis. Lower score indicates less severe illness. 25th percentile for time to relapse was reported.", 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Double-blind intent-to-treat population: All participants who received at least 1 dose of double-blind investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the Double-blind Treatment Phase.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cariprazine - Open-label Phase', 'description': 'Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this 20 week Open-label Phase.'}, {'id': 'FG001', 'title': 'Placebo - Double-blind Treatment Phase', 'description': 'Participants received placebo orally once a day for 26 to 72 weeks.'}, {'id': 'FG002', 'title': 'Cariprazine - Double-blind Treatment Phase', 'description': 'Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks.'}], 'periods': [{'title': 'Open-label Run-in Period (RIP)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '765'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '418'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '347'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Insufficient Therapeutic Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other Miscellaneous Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Period Between RIP and SP', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '418'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '364'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Insufficient Therapeutic Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other Miscellaneous Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Open-label Stabilization Period (SP)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '364'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '264'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Insufficient Therapeutic Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other Miscellaneous Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Period Between SP and DBP', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '264'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Did Not Met Criteria to Enter Next Phase', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other Miscellaneous Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Double-blind Treatment Phase (DBP)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '99'}, {'groupId': 'FG002', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '83'}, {'groupId': 'FG002', 'numSubjects': '83'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Other Miscellaneous Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '27'}]}, {'type': 'Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '25'}]}]}], 'preAssignmentDetails': 'A total of 765 participants were enrolled and received cariprazine in Run-in Phase; 751 of these, had at least 1 postbaseline Positive and Negative Syndrome Scale (PANSS) evaluation and 364 entered Stabilization Phase. Only 200 participants who completed Open-label phase, received either placebo (n=99) or cariprazine (n=101) in Double-Blind Phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '765', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cariprazine - Open-label Phase', 'description': 'Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this 20 week Open-label Phase.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.4', 'spread': '10.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '221', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '544', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '728', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '149', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '313', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '299', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '78.07', 'spread': '20.10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '170.98', 'spread': '9.95', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26.50', 'spread': '5.63', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist circumference', 'classes': [{'categories': [{'measurements': [{'value': '90.39', 'spread': '15.34', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Run-in Phase safety population: All participants who received at least 1 dose of open-label cariprazine during the Run-in Phase of the study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'There was no masking in the Open-Label Phase. There was masking in the Double-Blind Phase'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 765}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'dispFirstSubmitDate': '2015-09-25', 'completionDateStruct': {'date': '2014-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-05', 'studyFirstSubmitDate': '2011-08-04', 'dispFirstSubmitQcDate': '2015-09-25', 'resultsFirstSubmitDate': '2018-06-05', 'studyFirstSubmitQcDate': '2011-08-05', 'dispFirstPostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-05', 'studyFirstPostDateStruct': {'date': '2011-08-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time From Baseline to the First Symptom Relapse During the Double-blind Phase', 'timeFrame': 'Up to 34 Weeks and Bi-Weekly thereafter until Week 92', 'description': "Relapse was defined as meeting ≥1 of the following criteria:1-Hospitalization due to worsening of condition;2-increase in Positive and Negative Syndrome Scale(PANSS) total score by ≥30% for participants,scored ≥50 or a ≥10-point increase for participants,scored \\<50 at randomization;3-increase in Clinical Global Impressions-Severity(CGI-S) score by ≥2 points at Week 20;4-deliberate self-injury or aggressive behaviour;5-suicidal/homicidal ideation judged clinically significant by Investigator;6-score of \\>4 on 1 or more of following PANSS items:P1,P2,P3,P6,P7,G8 or G14. Second assessment not performed based on Investigator discretion.\n\nPANSS is 30-item rating scale. Each item scored on 7-point scale. Total score ranges from 30 to 210. Lower score indicates fewer schizophrenic symptoms. CGI-S is 7-point scale,measures severity of participant's illness in comparison with others with same diagnosis. Lower score indicates less severe illness. 25th percentile for time to relapse was reported."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Schizophrenic disorder'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '34091867', 'type': 'DERIVED', 'citation': 'Laszlovszky I, Barabassy A, Nemeth G. Cariprazine, A Broad-Spectrum Antipsychotic for the Treatment of Schizophrenia: Pharmacology, Efficacy, and Safety. Adv Ther. 2021 Jul;38(7):3652-3673. doi: 10.1007/s12325-021-01797-5. Epub 2021 Jun 6.'}, {'pmid': '33854317', 'type': 'DERIVED', 'citation': 'Barabassy A, Sebe B, Acsai K, Laszlovszky I, Szatmari B, Earley WR, Nemeth G. Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies. Neuropsychiatr Dis Treat. 2021 Apr 7;17:957-970. doi: 10.2147/NDT.S301225. eCollection 2021.'}, {'pmid': '30695290', 'type': 'DERIVED', 'citation': 'Correll CU, Potkin SG, Zhong Y, Harsanyi J, Szatmari B, Earley W. Long-Term Remission With Cariprazine Treatment in Patients With Schizophrenia: A Post Hoc Analysis of a Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Trial. J Clin Psychiatry. 2019 Jan 8;80(2):18m12495. doi: 10.4088/JCP.18m12495.'}, {'pmid': '27427558', 'type': 'DERIVED', 'citation': 'Durgam S, Earley W, Li R, Li D, Lu K, Laszlovszky I, Fleischhacker WW, Nasrallah HA. Long-term cariprazine treatment for the prevention of relapse in patients with schizophrenia: A randomized, double-blind, placebo-controlled trial. Schizophr Res. 2016 Oct;176(2-3):264-271. doi: 10.1016/j.schres.2016.06.030. Epub 2016 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy and safety of cariprazine relative to placebo in the prevention of relapse of symptoms in participants with schizophrenia.', 'detailedDescription': 'There were 3 periods (phases) in the study. The Open-label Phase lasted 20 weeks. In the first 6 weeks, participants received 3, 6, or 9 mg cariprazine orally once a day; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this Open-label Phase. At the end of Week 8, participants had to meet the following criteria to continue in the study.\n\n* Positive and Negative Syndrome Scale (PANSS) total score ≤ 60 at the end of Week 8\n* At least 20% decrease in PANSS total score from baseline to the end of Week 8\n* Clinical Global Impressions - Severity (CGI-S) score ≤ 4 at the end of Week 8\n* Score of ≤ 4 on each of the following 7 PANSS items: P1, P2, P3, P6, P7, G8, and G14 at the end of Week 8\n* Stable dose during the previous 2 weeks\n* No significant tolerability issues as judged by the Investigator at the end of Week 8\n\nAt the end of the Open-label Phase, participants were randomized into 2 treatment groups, cariprazine or placebo, if they met the following criteria:\n\n* PANSS total score ≤ 60 at the end of Week 20\n* At least 20% decrease in PANSS total score from baseline to the end of Week 20\n* CGI-S score ≤ 4 at the end of Week 20\n* Score of ≤ 4 on each of the following 7 PANSS items: P1, P2, P3, P6, P7, G8, and G14 at the end of Week 20\n* No significant tolerability issues as judged by the Investigator During this Double-blind Treatment Phase, participants received either placebo or cariprazine at the same dosage (3, 6, or 9 mg) that they received during the last 14 weeks of the Open-label Phase.\n\nAll participants entered the 4 week Safety Follow-up Phase. They received a treatment other than the investigational product at the discretion of the Investigator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who have provided informed consent prior to any study specific procedures.\n* Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria for schizophrenia.\n* Participants with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).\n* Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).\n* Positive and Negative Syndrome Scale (PANSS) total score ≥ to 70 and ≤ 120 at Visit 1 (Screening) and Visit 2 (beginning of Run-in Phase).\n* Negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test (applies to female participants of childbearing potential only).\n* Body mass index between 18 and 40 kg/m\\^2, inclusive.\n\nExclusion Criteria:\n\n* Participants currently meeting DSM-IV-TR criteria for schizoaffective disorder, schizophreniform disorder, bipolar I and II and known or suspected borderline or antisocial personality disorder. or other DSM-IV-TR axis II disorders.\n* Participants in their first episode of psychosis.\n* Treatment-resistant schizophrenia over the last 2 years.\n* Positive result from the blood alcohol test or from the urine drug screen for any prohibited medication.\n* At imminent risk of injuring self or others or causing significant damage to property.\n* Suicide risk.'}, 'identificationModule': {'nctId': 'NCT01412060', 'briefTitle': 'A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Cariprazine (RGH-188) in the Prevention of Relapse in Patients With Schizophrenia', 'orgStudyIdInfo': {'id': 'RGH-MD-06'}, 'secondaryIdInfos': [{'id': '2011-002048-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cariprazine - Open-label Phase', 'description': 'Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this 20 week Open-label Phase.', 'interventionNames': ['Drug: Cariprazine']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo - Double-blind Treatment Phase', 'description': 'Participants received placebo orally once a day for 26 to 72 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cariprazine - Double-blind Treatment Phase', 'description': 'Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks', 'interventionNames': ['Drug: Cariprazine']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo was supplied in capsules.', 'armGroupLabels': ['Placebo - Double-blind Treatment Phase']}, {'name': 'Cariprazine', 'type': 'DRUG', 'otherNames': ['RGH-188'], 'description': 'Cariprazine was supplied as 1.5 mg capsules (batch numbers BN0009242 and BN00018595) and 3 mg capsules.', 'armGroupLabels': ['Cariprazine - Double-blind Treatment Phase', 'Cariprazine - Open-label Phase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Forest Investigative Site 011', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90703', 'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 018', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 007', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '90230', 'city': 'Culver City', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 026', 'geoPoint': {'lat': 34.02112, 'lon': -118.39647}}, {'zip': '90813', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 008', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 002', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 019', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '90723', 'city': 'Paramount', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 001', 'geoPoint': {'lat': 33.88946, 'lon': -118.15979}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 020', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '20016', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Forest Investigative Site 005', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '34748', 'city': 'Leesburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 024', 'geoPoint': {'lat': 28.81082, 'lon': -81.87786}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Forest Investigative Site 017', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Forest Investigative Site 021', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21202', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Forest Investigative Site 023', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Forest Investigative Site 010', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '39232', 'city': 'Flowood', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Forest Investigative Site 003', 'geoPoint': {'lat': 32.30959, 'lon': -90.13898}}, {'zip': '63141', 'city': 'Creve Coeur', 'state': 'Missouri', 'country': 'United States', 'facility': 'Forest Investigative Site 006', 'geoPoint': {'lat': 38.66089, 'lon': -90.42262}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Forest Investigative Site 014', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11516', 'city': 'Cedarhurst', 'state': 'New York', 'country': 'United States', 'facility': 'Forest Investigative Site 012', 'geoPoint': {'lat': 40.62288, 'lon': -73.7243}}, {'zip': '45417', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Forest Investigative Site 022', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Forest Investigative Site 015', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78754', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Forest Investigative Site 027', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Forest Investigative Site 025', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77008', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Forest Investigative Site 013', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77021', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Forest Investigative Site 009', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '520002', 'city': 'Vijayawada', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Forest Investigative Site 305', 'geoPoint': {'lat': 16.50745, 'lon': 80.6466}}, {'zip': '380006', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Forest Investigative Site 303', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '380006', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Forest Investigative Site 308', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '380015', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Forest Investigative Site 310', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '575018', 'city': 'Mangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Forest Investigative Site 313', 'geoPoint': {'lat': 12.91723, 'lon': 74.85603}}, {'zip': '576104', 'city': 'Manipal', 'state': 'Karnataka', 'country': 'India', 'facility': 'Forest Investigative Site 314', 'geoPoint': {'lat': 13.35, 'lon': 74.78333}}, {'zip': '431005', 'city': 'Aurangabad', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Forest Investigative Site 301', 'geoPoint': {'lat': 19.87757, 'lon': 75.34226}}, {'zip': '421301', 'city': 'Kalyān', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Forest Investigative Site 306', 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'facility': 'Forest Investigative Site 304', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'zip': '221005', 'city': 'Varanasi', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'Forest Investigative Site 307', 'geoPoint': {'lat': 25.31668, 'lon': 83.01041}}, {'zip': '041914', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Forest Investigative Site 403', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '041914', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Forest Investigative Site 405', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '041914', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Forest Investigative Site 406', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '041914', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Forest Investigative Site 408', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '041914', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Forest Investigative Site 410', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '115100', 'city': 'Campulung Muscel', 'country': 'Romania', 'facility': 'Forest Investigative Site 407', 'geoPoint': {'lat': 45.26667, 'lon': 25.05}}, {'zip': '115100', 'city': 'Campulung Muscel', 'country': 'Romania', 'facility': 'Forest Investigative Site 412', 'geoPoint': {'lat': 45.26667, 'lon': 25.05}}, {'zip': '900002', 'city': 'Constanța', 'country': 'Romania', 'facility': 'Forest Investigative Site 402', 'geoPoint': {'lat': 44.18073, 'lon': 28.63432}}, {'zip': '620165', 'city': 'Focşani', 'country': 'Romania', 'facility': 'Forest Investigative Site 411', 'geoPoint': {'lat': 45.7, 'lon': 27.18333}}, {'zip': '700282', 'city': 'Iași', 'country': 'Romania', 'facility': 'Forest Investigative Site 401', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'zip': '700282', 'city': 'Iași', 'country': 'Romania', 'facility': 'Forest Investigative Site 409', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'zip': '130086', 'city': 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