Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
Study NCT ID:
NCT00711269
Status:
COMPLETED
Last Update Posted:
2022-04-12
First Post:
2008-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of SM-13496 (Lurasidone HCl) in Patients 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': 'D000069056', 'term': 'Lurasidone Hydrochloride'}, {'id': 'D018967', 'term': 'Risperidone'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cc@ds-pharma.co.jp', 'phone': '+81-3-5159-2519', 'title': 'Regional Function Head of CNS Research', 'organization': 'Clinical Research, Drug Development Division'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Baseline to up to 8 weeks', 'description': 'Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) with a start date on or after the date of the first dose through the end of follow-up, or AEs occurring before the date of first dose and worsening during the treatment or follow-up period. Both TEAEs and treatment-emergent serious AEs are presented for the safety population defined as subjects who receive at least one of the study drug in the treatment phase.', 'eventGroups': [{'id': 'EG000', 'title': 'SM-13496 (Lurasidone HCl) 40-mg Group', 'description': 'SM-13496 40 mg was administered orally once daily, for 6 weeks.', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 97, 'seriousNumAtRisk': 127, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'SM-13496 (Lurasidone HCl) 80-mg Group', 'description': 'SM-13496 40 mg was administered orally once daily on Days 1 to 7, SM-13496 60 mg on Days 8 to 14, and SM-13496 80 mg on Days 15 to 42.', 'otherNumAtRisk': 131, 'deathsNumAtRisk': 131, 'otherNumAffected': 124, 'seriousNumAtRisk': 131, 'deathsNumAffected': 1, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Placebo Group', 'description': 'Placebo was administered orally twice daily for 6 weeks.', 'otherNumAtRisk': 132, 'deathsNumAtRisk': 132, 'otherNumAffected': 91, 'seriousNumAtRisk': 132, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG003', 'title': 'Risperidone Group', 'description': 'Risperidone 2 mg was administered orally twice daily on Days 1 to 7, risperidone 3 mg on Days 8 to 14, and risperidone 4 mg on Days 15 to 42.', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 51, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dermoid cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ear haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Otorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Asthenopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Oculogyric crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blepharospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Stomach discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chapped lips', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Faecal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lip dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lip ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tooth loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 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'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SM-13496 (Lurasidone HCl) 40-mg Group', 'description': 'SM-13496 40 mg was administered orally once daily.'}, {'id': 'OG001', 'title': 'SM-13496 (Lurasidone HCl) 80-mg Group', 'description': 'SM-13496 80 mg was administered orally once daily.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Placebo was administered orally twice daily.'}, {'id': 'OG003', 'title': 'Risperidone Group', 'description': 'Risperidone was administered orally twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.1', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '1.72', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '1.72', 'groupId': 'OG002'}, {'value': '-7.1', 'spread': '2.44', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.149', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.5', 'ciLowerLimit': '-8.4', 'ciUpperLimit': '1.3', 'estimateComment': '\\[Not specified\\]', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'One-way Analysis of Variance (ANOVA)'}, {'pValue': '0.462', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-6.6', 'ciUpperLimit': '3.0', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'One-way Analysis of variance (ANOVA)'}, {'pValue': '0.122', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.6', 'ciLowerLimit': '-10.5', 'ciUpperLimit': '1.2', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'One-way Analysis of variance (ANOVA)'}, {'pValue': '0.235', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'Contrast Factors (Placebo, SM-13496 40-mg, SM-13496 80-mg): (-1, 0, 1) Adjusted P Value: 0.298', 'statisticalMethod': 'Maximum Contrast Method', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Contrast (Placebo, SM-13496 40-mg, SM-13496 80-mg):(-2, 1, 1) Raw P Value: 0.108 Adjusted P Value: 0.145', 'nonInferiorityComment': 'Maximum Contrast Method'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6 [Last Observation Carried Forward (LOCF)]', 'description': 'The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and three subscales: the Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility; the Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full Analysis Set)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the PANSS Positive Subscales at Week 6 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SM-13496 (Lurasidone HCl) 40-mg Group', 'description': 'SM-13496 40 mg was administered orally once daily.'}, {'id': 'OG001', 'title': 'SM-13496 (Lurasidone HCl) 80-mg Group', 'description': 'SM-13496 80 mg was administered orally once daily.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Placebo was administered orally twice daily.'}, {'id': 'OG003', 'title': 'Risperidone Group', 'description': 'Risperidone was administered orally twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '0.54', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '0.54', 'groupId': 'OG002'}, {'value': '-2.9', 'spread': '0.77', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.069', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'One-way Analysis of variance (ANOVA)'}, {'pValue': '0.287', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '0.7', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'One-way Analysis of variance (ANOVA)'}, {'pValue': '0.016', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '-0.4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'One-way Analysis of variance (ANOVA)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6 (LOCF)', 'description': 'The PANSS is comprised of 30 items and three subscales. The Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS Positive subscale score is the sum of all 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full Analysis Set)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the PANSS Negative Subscales at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SM-13496 (Lurasidone HCl) 40-mg Group', 'description': 'SM-13496 40 mg was administered orally once daily.'}, {'id': 'OG001', 'title': 'SM-13496 (Lurasidone HCl) 80-mg Group', 'description': 'SM-13496 80 mg was administered orally once daily.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Placebo was administered orally twice daily.'}, {'id': 'OG003', 'title': 'Risperidone Group', 'description': 'Risperidone was administered orally twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '0.46', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '0.46', 'groupId': 'OG002'}, {'value': '-1.7', 'spread': '0.65', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.289', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '0.6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'One-way Analysis of variance (ANOVA)'}, {'pValue': '0.256', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '0.5', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'One-way Analysis of variance (ANOVA)'}, {'pValue': '0.352', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '0.8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'One-way Analysis of variance (ANOVA)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6 (LOCF)', 'description': 'The PANSS is comprised of 30 items and three subscales. The Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS Negative subscale score is the sum of all 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full Analysis Set)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the PANSS General Psychopathology Subscales at Week 6 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SM-13496 (Lurasidone HCl) 40-mg Group', 'description': 'SM-13496 40 mg was administered orally once daily.'}, {'id': 'OG001', 'title': 'SM-13496 (Lurasidone HCl) 80-mg Group', 'description': 'SM-13496 80 mg was administered orally once daily.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Placebo was administered orally twice daily.'}, {'id': 'OG003', 'title': 'Risperidone Group', 'description': 'Risperidone was administered orally twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.88', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '0.88', 'groupId': 'OG002'}, {'value': '-2.6', 'spread': '1.25', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.251', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '1.0', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'One-way Analysis of variance (ANOVA)'}, {'pValue': '0.847', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '2.2', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'One-way Analysis of variance (ANOVA)'}, {'pValue': '0.292', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-4.6', 'ciUpperLimit': '1.4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'One-way Analysis of variance (ANOVA)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6 (LOCF)', 'description': 'The PANSS is comprised of 30 items and three subscales. The General Psychopathology subscale addresses other 16 symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS General Psychopathology subscale score is the sum of all 16 items and ranges from 16 through 112. A higher score is associated with greater illness severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full Analysis Set)'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SM-13496 (Lurasidone HCl) 40-mg Group', 'description': 'SM-13496 40 mg was administered orally once daily.'}, {'id': 'OG001', 'title': 'SM-13496 (Lurasidone HCl) 80-mg Group', 'description': 'SM-13496 80 mg was administered orally once daily.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Placebo was administered orally twice daily.'}, {'id': 'OG003', 'title': 'Risperidone Group', 'description': 'Placebo was administered orally twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline to up to 8 weeks', 'description': 'Proportion of participants with treatment-emergent adverse events. An adverse event was defined as any untoward medical occurrence in a study participant who was taking a medicinal (investigational) product. Treatment-emergent adverse events (TEAEs) were defined as adverse events with a start date on or after the date of the first dose through the end of follow-up, or adverse events occurring before the date of first dose and worsening during the treatment or follow-up period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population defined as subjects who receive at least one dose of the study drug in the treatment period.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With TEAEs Leading to Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SM-13496 (Lurasidone HCl) 40-mg Group', 'description': 'SM-13496 40 mg was administered orally once daily.'}, {'id': 'OG001', 'title': 'SM-13496 (Lurasidone HCl) 80-mg Group', 'description': 'SM-13496 80 mg was administered orally once daily.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Placebo was administered orally twice daily.'}, {'id': 'OG003', 'title': 'Risperidone Group', 'description': 'Risperidone was administered orally twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline to up to 8 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population defined as subjects who receive at least one dose of the study drug in the treatment period.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SM-13496 (Lurasidone HCl) 40-mg Group', 'description': 'SM-13496 40 mg was administered orally once daily.'}, {'id': 'OG001', 'title': 'SM-13496 (Lurasidone HCl) 80-mg Group', 'description': 'SM-13496 80 mg was administered orally once daily.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Placebo was administered orally twice daily.'}, {'id': 'OG003', 'title': 'Risperidone Group', 'description': 'Risperidone was administered orally twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline to up to 8 weeks', 'description': 'Proportion of participants with treatment-emergent adverse events. An adverse event was considered serious if it met one or more of the following criteria: Resulted in death; Was life-threatening (i.e., a patient was at immediate risk of death at the time of the event, not an event where occurrence in a more severe form might have caused death); Required in-patient hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity; Was a congenital anomaly/birth defect; Was considered to be an important medical event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population defined as subjects who receive at least one dose of the study drug in the treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SM-13496 (Lurasidone HCl) 40-mg Group', 'description': 'SM-13496 40 mg was administered orally once daily.'}, {'id': 'FG001', 'title': 'SM-13496 (Lurasidone HCl) 80-mg Group', 'description': 'SM-13496 80 mg was administered orally once daily.'}, {'id': 'FG002', 'title': 'Placebo Group', 'description': 'Placebo was administered orally twice daily.'}, {'id': 'FG003', 'title': 'Risperidone Group', 'description': 'Risperidone was administered orally twice daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '131'}, {'groupId': 'FG002', 'numSubjects': '133'}, {'groupId': 'FG003', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '83'}, {'groupId': 'FG002', 'numSubjects': '83'}, {'groupId': 'FG003', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '447', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'SM-13496 (Lurasidone HCl) 40-mg Group', 'description': 'SM-13496 40 mg was administered orally once daily.'}, {'id': 'BG001', 'title': 'SM-13496 (Lurasidone HCl) 80-mg Group', 'description': 'SM-13496 80 mg was administered orally once daily.'}, {'id': 'BG002', 'title': 'Placebo Group', 'description': 'Placebo was administered orally twice daily.'}, {'id': 'BG003', 'title': 'Risperidone Group', 'description': 'Risperidone 2 mg was administered orally twice daily.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.6', 'spread': '14.48', 'groupId': 'BG000'}, {'value': '45.7', 'spread': '13.51', 'groupId': 'BG001'}, {'value': '46.0', 'spread': '12.85', 'groupId': 'BG002'}, {'value': '44.8', 'spread': '12.59', 'groupId': 'BG003'}, {'value': '45.6', 'spread': '13.44', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '183', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '264', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '221', 'groupId': 'BG004'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '125', 'groupId': 'BG004'}]}]}, {'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '101', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 460}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2010-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-09', 'studyFirstSubmitDate': '2008-06-11', 'resultsFirstSubmitDate': '2017-06-27', 'studyFirstSubmitQcDate': '2008-07-04', 'lastUpdatePostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-22', 'studyFirstPostDateStruct': {'date': '2008-07-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (LOCF)', 'timeFrame': 'Baseline and Week 6 [Last Observation Carried Forward (LOCF)]', 'description': 'The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and three subscales: the Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility; the Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the PANSS Positive Subscales at Week 6 (LOCF)', 'timeFrame': 'Baseline and Week 6 (LOCF)', 'description': 'The PANSS is comprised of 30 items and three subscales. The Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS Positive subscale score is the sum of all 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.'}, {'measure': 'Change From Baseline in the PANSS Negative Subscales at Week 6', 'timeFrame': 'Baseline and Week 6 (LOCF)', 'description': 'The PANSS is comprised of 30 items and three subscales. The Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS Negative subscale score is the sum of all 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.'}, {'measure': 'Change From Baseline in the PANSS General Psychopathology Subscales at Week 6 (LOCF)', 'timeFrame': 'Baseline and Week 6 (LOCF)', 'description': 'The PANSS is comprised of 30 items and three subscales. The General Psychopathology subscale addresses other 16 symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS General Psychopathology subscale score is the sum of all 16 items and ranges from 16 through 112. A higher score is associated with greater illness severity.'}, {'measure': 'Proportion of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'From Baseline to up to 8 weeks', 'description': 'Proportion of participants with treatment-emergent adverse events. An adverse event was defined as any untoward medical occurrence in a study participant who was taking a medicinal (investigational) product. Treatment-emergent adverse events (TEAEs) were defined as adverse events with a start date on or after the date of the first dose through the end of follow-up, or adverse events occurring before the date of first dose and worsening during the treatment or follow-up period.'}, {'measure': 'Proportion of Participants With TEAEs Leading to Discontinuation', 'timeFrame': 'From Baseline to up to 8 weeks'}, {'measure': 'Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs)', 'timeFrame': 'From Baseline to up to 8 weeks', 'description': 'Proportion of participants with treatment-emergent adverse events. An adverse event was considered serious if it met one or more of the following criteria: Resulted in death; Was life-threatening (i.e., a patient was at immediate risk of death at the time of the event, not an event where occurrence in a more severe form might have caused death); Required in-patient hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity; Was a congenital anomaly/birth defect; Was considered to be an important medical event.'}]}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Main Inclusion Criteria:\n\n* Patient meets DSM-IV criteria for schizophrenia.\n* Patient is 18 or older but younger than 75 years of age on the day of signing informed consent.\n* Patient understands the objectives, nature, and other aspects of the study and voluntarily agrees to participate in the study by providing written informed consent.\n\nMain Exclusion Criteria:\n\n* Patient has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus.\n* Patient has Parkinson's disease.\n* Patient has a history or complication of malignancy."}, 'identificationModule': {'nctId': 'NCT00711269', 'briefTitle': 'Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sumitomo Pharma Co., Ltd.'}, 'officialTitle': 'Randomized, Placebo-controlled, Double-blind, Parallel-group, Confirmatory Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia <Phase III Study>', 'orgStudyIdInfo': {'id': 'D1001002'}, 'secondaryIdInfos': [{'id': 'JapicCTI-080585', 'type': 'REGISTRY', 'domain': 'JAPIC Clinical Trials Information'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SM-13496 (lurasidone HCl) 40mg', 'description': 'SM-13496 40 mg was administered orally once daily.', 'interventionNames': ['Drug: SM-13496 (lurasidone HCl)']}, {'type': 'EXPERIMENTAL', 'label': 'SM-13496 (lurasidone HCl) 80mg', 'description': 'SM-13496 80mg was administered orally once daily.', 'interventionNames': ['Drug: SM-13496 (lurasidone HCl)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo was administered orally twice daily.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Risperidone', 'description': 'Risperidone was administered orally twice daily.', 'interventionNames': ['Drug: Risperidone']}], 'interventions': [{'name': 'SM-13496 (lurasidone HCl)', 'type': 'DRUG', 'description': 'Lurasidone HCl: 40 mg/day', 'armGroupLabels': ['SM-13496 (lurasidone HCl) 40mg']}, {'name': 'SM-13496 (lurasidone HCl)', 'type': 'DRUG', 'description': 'Lurasidone HCl: 80 mg/day', 'armGroupLabels': ['SM-13496 (lurasidone HCl) 80mg']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}, {'name': 'Risperidone', 'type': 'DRUG', 'armGroupLabels': ['Risperidone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo, Etc.', 'country': 'Japan', 'facility': 'Japan: 67 sites', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Seoul, Etc.', 'country': 'South Korea', 'facility': 'Korea: 14 sites', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Taipei, Etc.', 'country': 'Taiwan', 'facility': 'Taiwan: 11 sites', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Drug Development Division', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sumitomo Pharma Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sumitomo Pharma Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}