Viewing Study NCT01808651

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Ignite Creation Date: 2025-12-24 @ 11:42 PM
Ignite Modification Date: 2026-02-20 @ 3:38 AM
Study NCT ID: NCT01808651
Status: COMPLETED
Last Update Posted: 2015-11-26
First Post: 2013-03-07
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study of Fluoxetine in Major Depressive Disorder (MDD) Long-Term Dosing
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005473', 'term': 'Fluoxetine'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.', 'eventGroups': [{'id': 'EG000', 'title': 'Study Period 1 PLA/FLX', 'description': 'Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.', 'otherNumAtRisk': 98, 'otherNumAffected': 74, 'seriousNumAtRisk': 98, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Study Period 1 FLX20/FLX', 'description': 'Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.', 'otherNumAtRisk': 65, 'otherNumAffected': 46, 'seriousNumAtRisk': 65, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Study Period 1 FLX40/FLX', 'description': 'Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.', 'otherNumAtRisk': 36, 'otherNumAffected': 29, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Study Period 2 Discontinued From PLA/FLX', 'description': 'Participants in the PLA/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2,', 'otherNumAtRisk': 77, 'otherNumAffected': 5, 'seriousNumAtRisk': 77, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Study Period 2 Discontinued From FLX20/FLX', 'description': 'Participants in the FLX20/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2.', 'otherNumAtRisk': 52, 'otherNumAffected': 7, 'seriousNumAtRisk': 52, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Study Period 2 Discontinued From FLX40/FLX', 'description': 'Participants in the FLX40/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2.', 'otherNumAtRisk': 33, 'otherNumAffected': 1, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': "Meniere's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Asthenopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Blepharospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Yawning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Miliaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Seborrhoeic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Wisdom teeth removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Intentional self-injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PLA/FLX', 'description': 'Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}, {'id': 'OG001', 'title': 'FLX20/FLX', 'description': 'Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}, {'id': 'OG002', 'title': 'FLX40/FLX', 'description': 'Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}], 'classes': [{'title': 'Participants with >=1 SAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Participants with >=1 AEs', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 52.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of the study drug were evaluated for AEs and SAEs. SAE reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 1.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PLA/FLX', 'description': 'Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}, {'id': 'OG001', 'title': 'FLX20/FLX', 'description': 'Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}, {'id': 'OG002', 'title': 'FLX40/FLX', 'description': 'Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 52', 'description': 'C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study drug with at least 1 post-baseline C-SSRS score during Study Period 1.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 52 on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PLA/FLX', 'description': 'Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}, {'id': 'OG001', 'title': 'FLX20/FLX', 'description': 'Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}, {'id': 'OG002', 'title': 'FLX40/FLX', 'description': 'Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.04', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '-11.25', 'spread': '0.90', 'groupId': 'OG001'}, {'value': '-11.70', 'spread': '1.16', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). Least squares (LS) means were calculated using mixed-model repeated measures (MMRM) adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline HAMD21 total score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during Study Period 1.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Response at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PLA/FLX', 'description': 'Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}, {'id': 'OG001', 'title': 'FLX20/FLX', 'description': 'Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}, {'id': 'OG002', 'title': 'FLX40/FLX', 'description': 'Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, up to Week 52', 'description': 'The percentage of participants achieving a response (defined as a ≥50% improvement from baseline on the HAMD21 total score) was calculated by dividing the number of participants achieving a response at last observation by the total number of participants at risk, multiplied by 100.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Remission at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PLA/FLX', 'description': 'Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}, {'id': 'OG001', 'title': 'FLX20/FLX', 'description': 'Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}, {'id': 'OG002', 'title': 'FLX40/FLX', 'description': 'Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to Week 52', 'description': 'The percentage of participants achieving a remission (defined as a HAMD21 total score ≤7) was calculated by dividing the number of participants achieving a remission at last observation by the total number of participants at risk, multiplied by 100.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study drug with a baseline (which had not achieved remission threshold criteria) and had at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 52 on the Clinical Global Impression of Severity (CGI-S) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PLA/FLX', 'description': 'Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}, {'id': 'OG001', 'title': 'FLX20/FLX', 'description': 'Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}, {'id': 'OG002', 'title': 'FLX40/FLX', 'description': 'Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.41', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-1.45', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '-1.64', 'spread': '0.16', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'CGI-S measures severity of illness at the time of assessment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline CGI-S score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline CGI-S score during the Treatment Period.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 52 on the HAMD21 Subscale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PLA/FLX', 'description': 'Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}, {'id': 'OG001', 'title': 'FLX20/FLX', 'description': 'Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}, {'id': 'OG002', 'title': 'FLX40/FLX', 'description': 'Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}], 'classes': [{'title': 'HAMD17 total scale', 'categories': [{'measurements': [{'value': '-9.06', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '-10.20', 'spread': '0.83', 'groupId': 'OG001'}, {'value': '-10.51', 'spread': '1.07', 'groupId': 'OG002'}]}]}, {'title': 'Maier subscale score', 'categories': [{'measurements': [{'value': '-4.73', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '-5.55', 'spread': '0.46', 'groupId': 'OG001'}, {'value': '-5.02', 'spread': '0.60', 'groupId': 'OG002'}]}]}, {'title': 'Anxiety/Somatization subscale score', 'categories': [{'measurements': [{'value': '-3.08', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '-3.16', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '-3.61', 'spread': '0.39', 'groupId': 'OG002'}]}]}, {'title': 'Retardation/Somatization subscale score', 'categories': [{'measurements': [{'value': '-3.45', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-3.98', 'spread': '0.32', 'groupId': 'OG001'}, {'value': '-3.55', 'spread': '0.42', 'groupId': 'OG002'}]}]}, {'title': 'Sleep subscale score', 'categories': [{'measurements': [{'value': '-1.49', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.34', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '-1.95', 'spread': '0.23', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'HAMD17 total scores and subscale scores from the HAMD21 are presented. HAMD17 is a 17-item assessment of depression severity (total scores range from 0-52). The Maier subscale (Items 1, 2, 7-10) represents the core symptoms of depression (0-24). Anxiety/Somatization subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifestations of anxiety as well as agitation (0-18). Retardation/Somatization subscale (Items 1, 7, 8, 14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation (0-14). Sleep subscale (Items 4-6) assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher scores indicate more severe symptoms. LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 subscale score. LSM (least square mean) and SE (standard error) are from visit 16.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in Sheehan Disability Scale (SDS) Total Score and Subscale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PLA/FLX', 'description': 'Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}, {'id': 'OG001', 'title': 'FLX20/FLX', 'description': 'Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}, {'id': 'OG002', 'title': 'FLX40/FLX', 'description': 'Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}], 'classes': [{'title': 'SDS Total Score', 'categories': [{'measurements': [{'value': '-6.53', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '-6.17', 'spread': '0.97', 'groupId': 'OG001'}, {'value': '-6.14', 'spread': '1.28', 'groupId': 'OG002'}]}]}, {'title': 'Work/School subscale (N:85, 60, 28)', 'categories': [{'measurements': [{'value': '-2.46', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '-2.62', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '-2.24', 'spread': '0.56', 'groupId': 'OG002'}]}]}, {'title': 'Social/Leisure subscale (N:98, 64, 36)', 'categories': [{'measurements': [{'value': '-2.11', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-2.11', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '-2.06', 'spread': '0.47', 'groupId': 'OG002'}]}]}, {'title': 'Family/Home subscale (N:98,64,36)', 'categories': [{'measurements': [{'value': '-1.93', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '-1.55', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '-2.01', 'spread': '0.41', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline up to 52 weeks', 'description': "SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/school (Item 1), social life/leisure activities (Item 2), and family life/home responsibilities (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total score was the sum of the 3 items and ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, pooled investigative site, and baseline SDS score.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline SDS score. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PLA/FLX', 'description': "Period 1: Participants (Pts) randomized to placebo in Study B1Y-JE-HCLV transitioned to fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.\n\nPeriod 2: 2-week observation phase following discontinuation (DC'd) of fluoxetine."}, {'id': 'FG001', 'title': 'FLX20/FLX', 'description': 'Period 1: Participants randomized to fluoxetine 20 mg /day in Study B1Y-JE-HCLV and continued on fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.\n\nPeriod 2: 2-week observation phase following discontinuation of fluoxetine.'}, {'id': 'FG002', 'title': 'FLX40/FLX', 'description': 'Period 1: Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.\n\nPeriod 2: 2-week observation phase following discontinuation of fluoxetine.'}], 'periods': [{'title': 'Study Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '36'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Participant Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}, {'title': 'Study Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': "9 Pts who DC'd from Study Period 1 and 68 Pts who completed Study Period 1 entered Study Period 2.", 'groupId': 'FG000', 'numSubjects': '77'}, {'comment': "5 Pts who DC'd from Study Period 1 and 47 Pts who completed Study Period 1 entered Study Period 2.", 'groupId': 'FG001', 'numSubjects': '52'}, {'comment': "3 Pts who DC'd from Study Period 1 and 30 pts who completed Study Period 1 entered Study Period 2.", 'groupId': 'FG002', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This study consisted of 2 study periods for Japanese participants who completed acute treatment in Study B1Y-JE-HCLV(NCT#: NCT01808612): Study period I was a 52-week open-label treatment period with fluoxetine 20 to 40 milligrams (mg), administered once daily, and Study period II was a 2-wk observation phase following discontinuation of fluoxetine.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '199', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'PLA/FLX (Placebo/Fluoxetine)', 'description': 'Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}, {'id': 'BG001', 'title': 'FLX20/FLX', 'description': 'Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}, {'id': 'BG002', 'title': 'FLX40/FLX', 'description': 'Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.60', 'spread': '12.95', 'groupId': 'BG000'}, {'value': '39.72', 'spread': '10.91', 'groupId': 'BG001'}, {'value': '41.20', 'spread': '10.51', 'groupId': 'BG002'}, {'value': '39.44', 'spread': '11.88', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '199', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '199', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-22', 'studyFirstSubmitDate': '2013-03-07', 'resultsFirstSubmitDate': '2015-10-22', 'studyFirstSubmitQcDate': '2013-03-08', 'lastUpdatePostDateStruct': {'date': '2015-11-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-10-22', 'studyFirstPostDateStruct': {'date': '2013-03-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs)', 'timeFrame': 'Baseline through Week 52.'}, {'measure': 'Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Baseline through Week 52', 'description': 'C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline to Week 52 on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score', 'timeFrame': 'Baseline, Week 52', 'description': 'HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). Least squares (LS) means were calculated using mixed-model repeated measures (MMRM) adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline HAMD21 total score.'}, {'measure': 'Percentage of Participants Achieving a Response at Week 52', 'timeFrame': 'Baseline, up to Week 52', 'description': 'The percentage of participants achieving a response (defined as a ≥50% improvement from baseline on the HAMD21 total score) was calculated by dividing the number of participants achieving a response at last observation by the total number of participants at risk, multiplied by 100.'}, {'measure': 'Percentage of Participants Achieving a Remission at Week 52', 'timeFrame': 'up to Week 52', 'description': 'The percentage of participants achieving a remission (defined as a HAMD21 total score ≤7) was calculated by dividing the number of participants achieving a remission at last observation by the total number of participants at risk, multiplied by 100.'}, {'measure': 'Mean Change From Baseline to Week 52 on the Clinical Global Impression of Severity (CGI-S) Scale', 'timeFrame': 'Baseline, Week 52', 'description': 'CGI-S measures severity of illness at the time of assessment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline CGI-S score.'}, {'measure': 'Mean Change From Baseline to Week 52 on the HAMD21 Subscale Scores', 'timeFrame': 'Baseline, Week 52', 'description': 'HAMD17 total scores and subscale scores from the HAMD21 are presented. HAMD17 is a 17-item assessment of depression severity (total scores range from 0-52). The Maier subscale (Items 1, 2, 7-10) represents the core symptoms of depression (0-24). Anxiety/Somatization subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifestations of anxiety as well as agitation (0-18). Retardation/Somatization subscale (Items 1, 7, 8, 14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation (0-14). Sleep subscale (Items 4-6) assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher scores indicate more severe symptoms. LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline score.'}, {'measure': 'Change From Baseline to Week 52 in Sheehan Disability Scale (SDS) Total Score and Subscale Scores', 'timeFrame': 'Baseline up to 52 weeks', 'description': "SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/school (Item 1), social life/leisure activities (Item 2), and family life/home responsibilities (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total score was the sum of the 3 items and ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, pooled investigative site, and baseline SDS score."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and effectiveness of fluoxetine flexible dosing in the treatment of MDD in adult Japanese participants.\n\nParticipants who complete the short-term treatment phase of Study B1Y-JE-HCLV (NCT#: NCT01808612) will be allowed to enroll in this study, and receive fluoxetine treatment for an additional 52 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have completed Study B1Y-JE-HCLV (NCT#:NCT01808612)\n* Agree to abstain from sexual activity or to use a reliable method of birth control\n\nExclusion Criteria:\n\n* Significant suicidal risk\n* Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, or post-traumatic stress disorder\n* Have a history of substance abuse or dependence within the past 6 months, excluding caffeine and nicotine\n* Need to use thioridazine or pimozide during the study\n* Have a positive urine drug screen for drugs with abuse potential\n* Female participants who are either pregnant, nursing, or have recently given birth, or male participants who are planning for their partners to be or become pregnant\n* Have frequent or severe allergic reactions to multiple medications\n* Have a serious or unstable medical illness or condition, or psychological condition\n* Participants deemed ineligible by the investigator or sub-investigator for other reasons'}, 'identificationModule': {'nctId': 'NCT01808651', 'briefTitle': 'A Study of Fluoxetine in Major Depressive Disorder (MDD) Long-Term Dosing', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3, Open-label, Long-Term Study to Evaluate the Safety of LY110140 Once Daily Dosing for 52-week in Japanese Patients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': '14596'}, 'secondaryIdInfos': [{'id': 'B1Y-JE-HCLW', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluoxetine', 'description': 'Flexible dosing of 20 to 40 milligrams (mg) administered orally, once daily, for approximately 52 weeks', 'interventionNames': ['Drug: Fluoxetine']}], 'interventions': [{'name': 'Fluoxetine', 'type': 'DRUG', 'otherNames': ['LY110140', 'Fluoxetine Hydrochloride', 'Prozac', 'Sarafem'], 'description': 'Administered orally', 'armGroupLabels': ['Fluoxetine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '471-8513', 'city': 'Aichi', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'zip': '270-0014', 'city': 'Chiba', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '800-0226', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '963-877', 'city': 'Fukushima', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'zip': '737-0143', 'city': 'Hiroshima', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '065-0012', 'city': 'Hokkaido', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '651-0097', 'city': 'Hyōgo', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'zip': '238-0042', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '616-8421', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '390-0303', 'city': 'Nagano', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'zip': '700-0907', 'city': 'Okayama', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '586-0012', 'city': 'Osaka', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '339-0057', 'city': 'Saitama', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '525-0037', 'city': 'Shiga', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.02247, 'lon': 138.13005}}, {'zip': '321-0953', 'city': 'Tochigi', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.38333, 'lon': 139.73333}}, {'zip': '170-0002', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}