Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT00849693
Status:
COMPLETED
Last Update Posted:
2012-04-19
First Post:
2009-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study in the Treatment of Children and Adolescents With Major Depressive Disorder
Sponsor:
Organization:
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'}, {'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Duloxetine 60 mg - Acute', 'description': 'Duloxetine 60 mg, orally, once daily for 10 weeks', 'otherNumAtRisk': 108, 'otherNumAffected': 76, 'seriousNumAtRisk': 108, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Duloxetine 30 mg - Acute', 'description': 'Duloxetine 30 mg, orally, once daily for 10 weeks', 'otherNumAtRisk': 116, 'otherNumAffected': 66, 'seriousNumAtRisk': 116, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Fluoxetine 20 mg - Acute', 'description': 'Fluoxetine 20 mg, orally, once daily for 10 weeks', 'otherNumAtRisk': 117, 'otherNumAffected': 69, 'seriousNumAtRisk': 117, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Placebo - Acute', 'description': 'Placebo capsules identical in appearance, color, taste, and smell to study drug, orally, once daily for 10 weeks', 'otherNumAtRisk': 122, 'otherNumAffected': 71, 'seriousNumAtRisk': 122, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Duloxetine 60 mg - Extension', 'description': 'Duloxetine 60-120 mg , orally, once daily for 6 months', 'otherNumAtRisk': 73, 'otherNumAffected': 49, 'seriousNumAtRisk': 73, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'Duloxetine 30 mg - Extension', 'description': "Duloxetine 60-120 mg , orally, once daily for 6 months\n\nOne participant who had completed the acute treatment phase and didn't go into the extension phase, was accidentally dispensed the drug at the last visit of the acute treatment phase. Based on intent-to-treat principal, this participant was included in the extension phase analyses for adverse events (AEs; resulting in one more participant being analyzed for AEs than the number of participants who started the extension phase \\[see Participant Flow section\\]).", 'otherNumAtRisk': 81, 'otherNumAffected': 46, 'seriousNumAtRisk': 81, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Fluoxetine 20 mg - Extension', 'description': 'Fluoxetine 20-40 mg, orally, once daily for 6 months', 'otherNumAtRisk': 84, 'otherNumAffected': 45, 'seriousNumAtRisk': 84, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'Placebo/Duloxetine - Extension', 'description': 'Duloxetine 60-120 mg , orally, once daily for 6 months', 'otherNumAtRisk': 82, 'otherNumAffected': 52, 'seriousNumAtRisk': 82, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Incorrect dose administered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 27, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 26, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Tuberculosis of peripheral lymph nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abnormal behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Depressive symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Homicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Self injurious behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Stevens-Johnson syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint", 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60mg', 'description': 'Duloxetine 60mg orally, once daily for 10 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-23.9', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '-21.6', 'spread': '1.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.193', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 10', 'description': 'CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment\\*visit, age category\\*visit and baseline\\*visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with both a baseline and at least one post-baseline value.'}, {'type': 'SECONDARY', 'title': "Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 36 Endpoint", 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60 mg / Duloxetine 60-120 mg', 'description': 'Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}, {'id': 'OG001', 'title': 'Duloxetine 30 mg/Duloxetine 60-120 mg', 'description': 'Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}, {'id': 'OG002', 'title': 'Fluoxetine 20 mg/Fluoxetine 20-40 mg', 'description': 'Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase'}, {'id': 'OG003', 'title': 'Placebo/Duloxetine 60-120 mg', 'description': 'Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.8', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '-7.4', 'spread': '1.23', 'groupId': 'OG001'}, {'value': '-10.0', 'spread': '1.17', 'groupId': 'OG002'}, {'value': '-9.0', 'spread': '1.84', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 10, Week 36', 'description': 'CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS means are adjusted for baseline, pooled investigator, age category, visit, age category\\*visit and baseline\\*visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with value during treatment phase and at least one post-Week 10 value.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint", 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 30mg', 'description': 'Duloxetine 30mg orally, once daily for 10 weeks'}, {'id': 'OG001', 'title': 'Fluoxetine 20mg', 'description': 'Fluoxetine 20mg orally, once daily for 10 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.6', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '-22.6', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '-21.6', 'spread': '1.27', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 10', 'description': 'CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment\\*visit, age category\\*visit and baseline\\*visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with both a baseline and at least one post-baseline value.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 10 Endpoint", 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60mg', 'description': 'Duloxetine 60mg orally, once daily for 10 weeks'}, {'id': 'OG001', 'title': 'Duloxetine 30mg', 'description': 'Duloxetine 30mg orally, once daily for 10 weeks'}, {'id': 'OG002', 'title': 'Fluoxetine 20mg', 'description': 'Fluoxetine 20mg orally, once daily for 10 weeks'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks'}], 'classes': [{'title': 'Mood', 'categories': [{'measurements': [{'value': '-7.1', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '0.44', 'groupId': 'OG001'}, {'value': '-6.6', 'spread': '0.43', 'groupId': 'OG002'}, {'value': '-6.4', 'spread': '0.43', 'groupId': 'OG003'}]}]}, {'title': 'Somatic', 'categories': [{'measurements': [{'value': '-7.6', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '-7.9', 'spread': '0.48', 'groupId': 'OG001'}, {'value': '-7.1', 'spread': '0.47', 'groupId': 'OG002'}, {'value': '-6.4', 'spread': '0.47', 'groupId': 'OG003'}]}]}, {'title': 'Subjective', 'categories': [{'measurements': [{'value': '-3.6', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '0.26', 'groupId': 'OG002'}, {'value': '-3.6', 'spread': '0.26', 'groupId': 'OG003'}]}]}, {'title': 'Behavior', 'categories': [{'measurements': [{'value': '-5.8', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '-5.6', 'spread': '0.36', 'groupId': 'OG001'}, {'value': '-5.6', 'spread': '0.35', 'groupId': 'OG002'}, {'value': '-5.4', 'spread': '0.35', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 10', 'description': 'CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment\\*visit, age category\\*visit and baseline\\*visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with both a baseline and at least one post-baseline values.'}, {'type': 'SECONDARY', 'title': "Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint", 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60 mg / Duloxetine 60-120 mg', 'description': 'Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}, {'id': 'OG001', 'title': 'Duloxetine 30 mg/Duloxetine 60-120 mg', 'description': 'Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}, {'id': 'OG002', 'title': 'Fluoxetine 20 mg/Fluoxetine 20-40 mg', 'description': 'Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase'}, {'id': 'OG003', 'title': 'Placebo/Duloxetine 60-120 mg', 'description': 'Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}], 'classes': [{'title': 'Mood', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '0.42', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '0.44', 'groupId': 'OG002'}, {'value': '-2.3', 'spread': '0.59', 'groupId': 'OG003'}]}]}, {'title': 'Somatic', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '-4.0', 'spread': '0.47', 'groupId': 'OG002'}, {'value': '-3.2', 'spread': '0.66', 'groupId': 'OG003'}]}]}, {'title': 'Subjective', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '0.21', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '0.32', 'groupId': 'OG003'}]}]}, {'title': 'Behavior', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '0.32', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '0.28', 'groupId': 'OG002'}, {'value': '-2.4', 'spread': '0.50', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 10, Week 36', 'description': 'CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, age category\\*visit and baseline\\*visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with value during treatment phase and at least one post-Week 10 value.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60mg', 'description': 'Duloxetine 60mg orally, once daily for 10 weeks'}, {'id': 'OG001', 'title': 'Duloxetine 30mg', 'description': 'Duloxetine 30mg orally, once daily for 10 weeks'}, {'id': 'OG002', 'title': 'Fluoxetine 20mg', 'description': 'Fluoxetine 20mg orally, once daily for 10 weeks'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '0.11', 'groupId': 'OG002'}, {'value': '-1.4', 'spread': '0.11', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 10', 'description': 'CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment\\*visit, age category\\*visit and baseline\\*visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with both a baseline and at least one post-baseline value.'}, {'type': 'SECONDARY', 'title': 'Change From Week 10 in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 36 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60 mg / Duloxetine 60-120 mg', 'description': 'Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}, {'id': 'OG001', 'title': 'Duloxetine 30 mg/Duloxetine 60-120 mg', 'description': 'Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}, {'id': 'OG002', 'title': 'Fluoxetine 20 mg/Fluoxetine 20-40 mg', 'description': 'Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase'}, {'id': 'OG003', 'title': 'Placebo/Duloxetine 60-120 mg', 'description': 'Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '0.12', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '0.13', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 10, Week 36', 'description': 'CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, age category\\*visit and baseline\\*visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with value during treatment phase and at least one post-Week 10 value.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Suicidal Ideation or Suicidal Behavior Baseline Through Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60mg', 'description': 'Duloxetine 60mg orally, once daily for 10 weeks'}, {'id': 'OG001', 'title': 'Duloxetine 30mg', 'description': 'Duloxetine 30mg orally, once daily for 10 weeks'}, {'id': 'OG002', 'title': 'Fluoxetine 20mg', 'description': 'Fluoxetine 20mg orally, once daily for 10 weeks'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks'}], 'classes': [{'title': 'Suicidal Ideation', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'Suicidal Behavior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Treatment Emergent Suicidal Ideation', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 10', 'description': 'Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: 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: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week -1 to 0).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with a baseline and at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Suicidal Ideation or Suicidal Behavior Week 10 Through Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60 mg / Duloxetine 60-120 mg', 'description': 'Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}, {'id': 'OG001', 'title': 'Duloxetine 30 mg/Duloxetine 60-120 mg', 'description': 'Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}, {'id': 'OG002', 'title': 'Fluoxetine 20 mg/Fluoxetine 20-40 mg', 'description': 'Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase'}, {'id': 'OG003', 'title': 'Placebo/Duloxetine 60-120 mg', 'description': 'Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}], 'classes': [{'title': 'Suicidal Ideation', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Suicidal Behavior', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Treatment Emergent Suicidal Ideation', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 10 through Week 36', 'description': 'Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: 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: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week 7-10).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with a baseline and at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60mg', 'description': 'Duloxetine 60mg orally, once daily for 10 weeks'}, {'id': 'OG001', 'title': 'Duloxetine 30mg', 'description': 'Duloxetine 30mg orally, once daily for 10 weeks'}, {'id': 'OG002', 'title': 'Fluoxetine 20mg', 'description': 'Fluoxetine 20mg orally, once daily for 10 weeks'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks'}], 'classes': [{'title': 'ALT≥3 x ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ALT≥5 x ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ALT≥10 x ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ALT≥3 x ULN and Total Bilirubin≥2 x ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 10', 'description': 'Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with normal ALT value (ALT\\<1 x ULN) at last non-missing baseline visit and at least one non-missing post-baseline value.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60 mg / Duloxetine 60-120 mg', 'description': 'Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}, {'id': 'OG001', 'title': 'Duloxetine 30 mg/Duloxetine 60-120 mg', 'description': 'Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}, {'id': 'OG002', 'title': 'Fluoxetine 20 mg/Fluoxetine 20-40 mg', 'description': 'Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase'}, {'id': 'OG003', 'title': 'Placebo/Duloxetine 60-120 mg', 'description': 'Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}], 'classes': [{'title': 'ALT≥3 x ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ALT≥5 x ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ALT≥10 x ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ALT≥3 x ULN and Total Bilirubin≥2 x ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 10 through Week 36', 'description': 'Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as ALT ≥3 x ULN, ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT≥3 x ULN and Total Bilirubin ≥2 x ULN.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with normal ALT value (ALT\\<1 x ULN) at last non-missing visit before Week 10 and at least one non-missing post-Week 10 value.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Baseline Through Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60mg', 'description': 'Duloxetine 60mg orally, once daily for 10 weeks'}, {'id': 'OG001', 'title': 'Duloxetine 30mg', 'description': 'Duloxetine 30mg orally, once daily for 10 weeks'}, {'id': 'OG002', 'title': 'Fluoxetine 20mg', 'description': 'Fluoxetine 20mg orally, once daily for 10 weeks'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks'}], 'classes': [{'title': 'Diastolic BP Increase (N=93, 100, 99, 110)', 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000'}, {'value': '7.0', 'groupId': 'OG001'}, {'value': '10.1', 'groupId': 'OG002'}, {'value': '4.5', 'groupId': 'OG003'}]}]}, {'title': 'Systolic BP Increase (N=88, 95, 93, 98)', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '12.6', 'groupId': 'OG001'}, {'value': '12.9', 'groupId': 'OG002'}, {'value': '10.2', 'groupId': 'OG003'}]}]}, {'title': 'Pulse Decrease (N=100, 108, 108, 112)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Pulse Increase (N=105, 114, 112, 117)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Weight Decrease (N=105, 114, 112, 117)', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}, {'value': '8.8', 'groupId': 'OG001'}, {'value': '11.6', 'groupId': 'OG002'}, {'value': '5.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 10', 'description': 'PCS increase in systolic and diastolic BP was defined as increase of ≥5 millimeter mercury (mm Hg) from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as \\>140 and increase of ≥15 from BL high value for age 7-11 and \\>120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as \\<60 and a decrease of ≥25 from BL low value for age 7-11 and \\<50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with normal baseline value and at least one post-baseline value, and who were at risk for the specific PCS criteria.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Week 10 Through Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Duloxetine 60 mg / Duloxetine 60-120 mg', 'description': 'Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}, {'id': 'OG001', 'title': 'Duloxetine 30 mg/Duloxetine 60-120 mg', 'description': 'Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}, {'id': 'OG002', 'title': 'Fluoxetine 20 mg/Fluoxetine 20-40 mg', 'description': 'Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase'}, {'id': 'OG003', 'title': 'Placebo/Duloxetine 60-120 mg', 'description': 'Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}], 'classes': [{'title': 'Diastolic BP Increase (N=55, 65, 64, 69)', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000'}, {'value': '4.6', 'groupId': 'OG001'}, {'value': '20.3', 'groupId': 'OG002'}, {'value': '11.6', 'groupId': 'OG003'}]}]}, {'title': 'Systolic BP Increase (N=53, 62, 57, 57)', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000'}, {'value': '6.5', 'groupId': 'OG001'}, {'value': '7.0', 'groupId': 'OG002'}, {'value': '10.5', 'groupId': 'OG003'}]}]}, {'title': 'Pulse Decrease (N=68, 75, 76, 73)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Pulse Increase (N=71, 78, 81, 79)', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1.3', 'groupId': 'OG003'}]}]}, {'title': 'Weight Decrease (N=71, 78, 81, 79)', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '9.0', 'groupId': 'OG001'}, {'value': '3.7', 'groupId': 'OG002'}, {'value': '13.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 10 through Week 36', 'description': 'PCS increase in systolic and diastolic BP was defined as increase of ≥5 mm Hg from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as \\>140 and increase of ≥15 from BL high value for age 7-11 and \\>120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as \\<60 and a decrease of ≥25 from BL low value for age 7-11 and \\<50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participates with normal value before week 10 and at least one non-missing post-Week 10 value, and who are at risk for the specific PCS criteria.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Duloxetine 60 mg / Duloxetine 60-120 mg', 'description': 'Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}, {'id': 'FG001', 'title': 'Duloxetine 30 mg/Duloxetine 60-120 mg', 'description': 'Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}, {'id': 'FG002', 'title': 'Fluoxetine 20 mg/Fluoxetine 20-40 mg', 'description': 'Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase'}, {'id': 'FG003', 'title': 'Placebo/Duloxetine 60-120 mg', 'description': 'Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}], 'periods': [{'title': 'Acute Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '116'}, {'groupId': 'FG002', 'numSubjects': '117'}, {'groupId': 'FG003', 'numSubjects': '122'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': "2 didn't enter extension phase.", 'groupId': 'FG000', 'numSubjects': '75'}, {'comment': "1 didn't enter extension phase", 'groupId': 'FG001', 'numSubjects': '81'}, {'groupId': 'FG002', 'numSubjects': '84'}, {'comment': "3 didn't enter extension phase", 'groupId': 'FG003', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Parent or caregiver decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}, {'title': 'Extension Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '84'}, {'groupId': 'FG003', 'numSubjects': '82'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '49'}, {'groupId': 'FG003', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'Parent or caregiver decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'This study consisted of a 10-week acute treatment phase, and a 6-month extension phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}, {'value': '463', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Duloxetine 60 mg / Duloxetine 60-120 mg', 'description': 'Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}, {'id': 'BG001', 'title': 'Duloxetine 30 mg/Duloxetine 60-120 mg', 'description': 'Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}, {'id': 'BG002', 'title': 'Fluoxetine 20 mg/Fluoxetine 20-40 mg', 'description': 'Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase'}, {'id': 'BG003', 'title': 'Placebo/Duloxetine 60-120 mg', 'description': 'Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12.92', 'spread': '2.925', 'groupId': 'BG000'}, {'value': '12.86', 'spread': '2.904', 'groupId': 'BG001'}, {'value': '13.04', 'spread': '3.205', 'groupId': 'BG002'}, {'value': '13.09', 'spread': '2.895', 'groupId': 'BG003'}, {'value': '12.98', 'spread': '2.977', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}, {'value': '237', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '226', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '93', 'groupId': 'BG004'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '244', 'groupId': 'BG004'}]}]}, {'title': 'Multiracial', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}]}]}, {'title': 'Not Provided', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participant'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}, {'value': '364', 'groupId': 'BG004'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': "Children's Depression Rating Scale-Revised (CDRS-R) Total Score", 'classes': [{'categories': [{'measurements': [{'value': '59.3', 'spread': '10.87', 'groupId': 'BG000'}, {'value': '59.8', 'spread': '11.00', 'groupId': 'BG001'}, {'value': '57.9', 'spread': '10.11', 'groupId': 'BG002'}, {'value': '58.2', 'spread': '9.35', 'groupId': 'BG003'}, {'value': '58.8', 'spread': '10.33', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CDRS-R Subscale Scores', 'classes': [{'title': 'Mood', 'categories': [{'measurements': [{'value': '16.6', 'spread': '3.69', 'groupId': 'BG000'}, {'value': '16.4', 'spread': '3.64', 'groupId': 'BG001'}, {'value': '16.0', 'spread': '3.52', 'groupId': 'BG002'}, {'value': '16.0', 'spread': '3.38', 'groupId': 'BG003'}, {'value': '16.2', 'spread': '3.55', 'groupId': 'BG004'}]}]}, {'title': 'Somatic', 'categories': [{'measurements': [{'value': '19.6', 'spread': '4.58', 'groupId': 'BG000'}, {'value': '19.7', 'spread': '4.87', 'groupId': 'BG001'}, {'value': '19.3', 'spread': '4.60', 'groupId': 'BG002'}, {'value': '19.5', 'spread': '4.28', 'groupId': 'BG003'}, {'value': '19.5', 'spread': '4.57', 'groupId': 'BG004'}]}]}, {'title': 'Subjective', 'categories': [{'measurements': [{'value': '10.1', 'spread': '3.51', 'groupId': 'BG000'}, {'value': '10.6', 'spread': '3.60', 'groupId': 'BG001'}, {'value': '10.0', 'spread': '3.35', 'groupId': 'BG002'}, {'value': '10.0', 'spread': '2.79', 'groupId': 'BG003'}, {'value': '10.2', 'spread': '3.32', 'groupId': 'BG004'}]}]}, {'title': 'Behavior', 'categories': [{'measurements': [{'value': '13.0', 'spread': '3.04', 'groupId': 'BG000'}, {'value': '13.1', 'spread': '3.19', 'groupId': 'BG001'}, {'value': '12.7', 'spread': '3.12', 'groupId': 'BG002'}, {'value': '12.6', 'spread': '3.14', 'groupId': 'BG003'}, {'value': '12.8', 'spread': '3.12', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'CDRS-R Subscale score include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Clinical Global Impressions of Severity (CGI-Severity) score', 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '0.65', 'groupId': 'BG000'}, {'value': '4.6', 'spread': '0.65', 'groupId': 'BG001'}, {'value': '4.6', 'spread': '0.59', 'groupId': 'BG002'}, {'value': '4.5', 'spread': '0.63', 'groupId': 'BG003'}, {'value': '4.6', 'spread': '0.63', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'CGI-Severity score evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, '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': 463}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-26', 'studyFirstSubmitDate': '2009-02-23', 'resultsFirstSubmitDate': '2012-02-22', 'studyFirstSubmitQcDate': '2009-02-23', 'lastUpdatePostDateStruct': {'date': '2012-04-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-26', 'studyFirstPostDateStruct': {'date': '2009-02-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint", 'timeFrame': 'Baseline, Week 10', 'description': 'CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment\\*visit, age category\\*visit and baseline\\*visit.'}], 'secondaryOutcomes': [{'measure': "Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 36 Endpoint", 'timeFrame': 'Week 10, Week 36', 'description': 'CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS means are adjusted for baseline, pooled investigator, age category, visit, age category\\*visit and baseline\\*visit.'}, {'measure': "Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint", 'timeFrame': 'Baseline, Week 10', 'description': 'CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment\\*visit, age category\\*visit and baseline\\*visit.'}, {'measure': "Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 10 Endpoint", 'timeFrame': 'Baseline, Week 10', 'description': 'CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment\\*visit, age category\\*visit and baseline\\*visit.'}, {'measure': "Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint", 'timeFrame': 'Week 10, Week 36', 'description': 'CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, age category\\*visit and baseline\\*visit.'}, {'measure': 'Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10 Endpoint', 'timeFrame': 'Baseline, Week 10', 'description': 'CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment\\*visit, age category\\*visit and baseline\\*visit.'}, {'measure': 'Change From Week 10 in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 36 Endpoint', 'timeFrame': 'Week 10, Week 36', 'description': 'CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, age category\\*visit and baseline\\*visit.'}, {'measure': 'Number of Participants With Suicidal Ideation or Suicidal Behavior Baseline Through Week 10', 'timeFrame': 'Baseline through Week 10', 'description': 'Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: 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: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week -1 to 0).'}, {'measure': 'Number of Participants With Suicidal Ideation or Suicidal Behavior Week 10 Through Week 36', 'timeFrame': 'Week 10 through Week 36', 'description': 'Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: 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: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week 7-10).'}, {'measure': 'Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10', 'timeFrame': 'Baseline through Week 10', 'description': 'Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN.'}, {'measure': 'Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36', 'timeFrame': 'Week 10 through Week 36', 'description': 'Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as ALT ≥3 x ULN, ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT≥3 x ULN and Total Bilirubin ≥2 x ULN.'}, {'measure': 'Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Baseline Through Week 10', 'timeFrame': 'Baseline through Week 10', 'description': 'PCS increase in systolic and diastolic BP was defined as increase of ≥5 millimeter mercury (mm Hg) from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as \\>140 and increase of ≥15 from BL high value for age 7-11 and \\>120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as \\<60 and a decrease of ≥25 from BL low value for age 7-11 and \\<50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.'}, {'measure': 'Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Week 10 Through Week 36', 'timeFrame': 'Week 10 through Week 36', 'description': 'PCS increase in systolic and diastolic BP was defined as increase of ≥5 mm Hg from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as \\>140 and increase of ≥15 from BL high value for age 7-11 and \\>120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as \\<60 and a decrease of ≥25 from BL low value for age 7-11 and \\<50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '25978741', 'type': 'DERIVED', 'citation': 'Emslie GJ, Wells TG, Prakash A, Zhang Q, Pangallo BA, Bangs ME, March JS. Acute and longer-term safety results from a pooled analysis of duloxetine studies for the treatment of children and adolescents with major depressive disorder. J Child Adolesc Psychopharmacol. 2015 May;25(4):293-305. doi: 10.1089/cap.2014.0076.'}, {'pmid': '24815533', 'type': 'DERIVED', 'citation': 'Emslie GJ, Prakash A, Zhang Q, Pangallo BA, Bangs ME, March JS. A double-blind efficacy and safety study of duloxetine fixed doses in children and adolescents with major depressive disorder. J Child Adolesc Psychopharmacol. 2014 May;24(4):170-9. doi: 10.1089/cap.2013.0096. Epub 2014 May 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether duloxetine is superior to placebo in the treatment of children and adolescents with major depressive disorder (MDD)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Outpatient, diagnosed with major depressive disorder (MDD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and supported by the Mini International Neuropsychiatric Interview for children and adolescents (MINI-KID).\n* Diagnosis of moderate or greater severity of MDD as determined by Children's Depression Rating Scale - Revised (CDRS-R) with a total score greater than or equal to 40 at screen, and randomization and a Clinical Global Impression of Severity (CGI-Severity) rating of greater than or equal to 4 at screen, and randomization.\n* Female patients must test negative for pregnancy during screening.\n* Judged to be reliable by the investigator to keep all appointments for clinical visits, tests, and procedures required by the protocol.\n* Has a degree of understanding such that they can communicate intelligently with the investigator and study coordinator.\n* Capable of swallowing study drug whole. It is anticipated the patients will need to swallow up to 6 capsules per day.\n* Patients must have venous access sufficient to allow blood sampling and are compliant with blood draws as per the protocol.\n\nExclusion Criteria:\n\n* Children of site personnel directly affiliated with this study and/or their immediate families.\n* Children of Lilly employees or employees of the designated clinical research organization (CRO) assisting with the conduct of the study.\n* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.\n* Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, or pervasive development disorder, as judged by the investigator.\n* Have a history of DSM-IV-TR-defined substance abuse or dependence within the past year, excluding caffeine and nicotine.\n* Have a current primary DSM-IV-TR Axis I disorder other than MDD or a current secondary DSM-IV-TR Axis I disorder that requires any pharmacologic treatment\n* Have 1 or more first-degree relatives with diagnosed bipolar I disorder.\n* Have a significant suicide attempt within 1 year of screening or are currently at risk of suicide in the opinion of the investigator.\n* Have a weight less than 20 kilogram (kg) at screening.\n* Have a lack of response to 2 or more adequate treatment trials of antidepressants at a clinically appropriate dose for a minimum of 4 weeks for the same MDD episode.\n* Have initiated, stopped, or changed the type or intensity of psychotherapy within 6 weeks prior to screening.\n* Have a history of seizure disorder (other than febrile seizures).\n* Have a history of electroconvulsive therapy within 1 year of screening.\n* Have had treatment with a monoamine oxidase inhibitor (MAOI) within 14 days or fluoxetine within 30 days of randomization; or the potential need to use an MAOI during the study or within 5 weeks of discontinuation of study drug.\n* Have previously enrolled, completed, or withdrawn from this study or any other study investigating duloxetine or fluoxetine.\n* Have a positive urine drug screen for any substances of abuse or excluded medication.\n* Are taking any excluded medications that cannot be discontinued by screening.\n* Have known hypersensitivity to duloxetine, fluoxetine, or their inactive ingredients; or have frequent or severe allergic reactions to multiple medications.\n* Have uncontrolled narrow-angle glaucoma.\n* Have acute liver injury or severe cirrhosis.\n* Have a serious or unstable medical illness, psychological condition, or clinically significant laboratory or electrocardiogram (ECG) result that, in the opinion of the investigator, would compromise participation in the study or be likely to lead to hospitalization.\n* Have abnormal thyroid-stimulating hormone concentration.\n* Have initiated or discontinued hormone therapy within the previous 3 months.\n* Female patients who are either pregnant, nursing or have recently given birth.\n* Need to use thioridazine during the study or within 5 weeks after discontinuation of study drug or need to use pimozide during the study."}, 'identificationModule': {'nctId': 'NCT00849693', 'briefTitle': 'A Study in the Treatment of Children and Adolescents With Major Depressive Disorder', 'nctIdAliases': ['NCT00892294'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Major Depressive Disorder', 'orgStudyIdInfo': {'id': '7109'}, 'secondaryIdInfos': [{'id': 'F1J-MC-HMCL', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluoxetine', 'interventionNames': ['Drug: fluoxetine']}, {'type': 'EXPERIMENTAL', 'label': 'Duloxetine 60 mg', 'interventionNames': ['Drug: duloxetine']}, {'type': 'EXPERIMENTAL', 'label': 'Duloxetine 30 mg', 'interventionNames': ['Drug: duloxetine']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsules identical in appearance, color, taste, and smell to study drug, orally, once daily for 10 weeks (acute treatment phase)', 'armGroupLabels': ['Placebo']}, {'name': 'fluoxetine', 'type': 'DRUG', 'otherNames': ['LY110140', 'Prozac'], 'description': '20 milligram (mg) orally, once daily for 10 weeks (acute treatment phase) and 20-40 mg orally, once daily for additional 6 months (extension phase)', 'armGroupLabels': ['Fluoxetine']}, {'name': 'duloxetine', 'type': 'DRUG', 'otherNames': ['LY248686', 'Cymbalta'], 'description': '60 mg orally, once daily for 10 weeks (acute treatment phase) and 60-120 mg orally, once daily for additional 6 months (extension phase)', 'armGroupLabels': ['Duloxetine 60 mg']}, {'name': 'duloxetine', 'type': 'DRUG', 'otherNames': ['LY248686', 'Cymbalta'], 'description': '30 mg orally, once daily for 10 weeks (acute treatment phase) and 60-120 mg orally, once daily for additional 6 months (extension phase)', 'armGroupLabels': ['Duloxetine 30 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', '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': 33.52066, 'lon': -86.80249}}, {'zip': '36303', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', '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': 31.22323, 'lon': -85.39049}}, {'zip': '72223', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', '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': 34.74648, 'lon': -92.28959}}, {'zip': '90746', 'city': 'Carson', 'state': 'California', 'country': 'United States', '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': 33.83141, 'lon': -118.28202}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', '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': 33.11921, 'lon': -117.08642}}, {'zip': '92251', 'city': 'Imperial', 'state': 'California', 'country': 'United States', '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': 32.84755, 'lon': -115.56944}}, {'zip': '92506', 'city': 'Riverside', 'state': 'California', 'country': 'United States', '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': 33.95335, 'lon': -117.39616}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', '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': 32.71571, 'lon': -117.16472}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', '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': 39.72943, 'lon': -104.83192}}, {'zip': '06457', 'city': 'Middletown', 'state': 'Connecticut', 'country': 'United States', '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': 41.56232, 'lon': -72.65065}}, {'zip': '34208', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', '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': 27.49893, 'lon': -82.57482}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', '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': 29.65163, 'lon': -82.32483}}, {'zip': '33013', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', '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': 25.8576, 'lon': -80.27811}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', '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': 30.33218, 'lon': -81.65565}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', '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': 25.89009, 'lon': -80.18671}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', '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': 27.94752, 'lon': -82.45843}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', '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': 26.71534, 'lon': -80.05337}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', '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': 28.6, 'lon': -81.33924}}, {'zip': '60523', 'city': 'Oak Brook', 'state': 'Illinois', 'country': 'United States', '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': 41.83281, 'lon': -87.92895}}, {'zip': '47802', 'city': 'Terre Haute', 'state': 'Indiana', 'country': 'United States', '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': 39.4667, 'lon': -87.41391}}, {'zip': '67114', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', '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': 37.69224, 'lon': -97.33754}}, {'zip': '70601', 'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', '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': 30.21309, 'lon': -93.2044}}, {'zip': '21208', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', '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': 39.29038, 'lon': -76.61219}}, {'zip': '21061', 'city': 'Glen Burnie', 'state': 'Maryland', 'country': 'United States', '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': 39.16261, 'lon': -76.62469}}, {'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', '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': 39.084, 'lon': -77.15276}}, {'zip': '48038', 'city': 'Clinton Twp', 'state': 'Michigan', 'country': 'United States', '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': '68510', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', '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': 40.8, 'lon': -96.66696}}, {'zip': '87109', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', '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': 35.08449, 'lon': -106.65114}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', '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': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', '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': 41.4995, 'lon': -81.69541}}, {'zip': '73139', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', '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': 35.46756, 'lon': -97.51643}}, {'zip': '97301', 'city': 'Salem', 'state': 'Oregon', 'country': 'United States', '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': 44.9429, 'lon': -123.0351}}, {'zip': '19139', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', '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': 39.95238, 'lon': -75.16362}}, {'zip': '29407', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', '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': 32.77632, 'lon': -79.93275}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', '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': 35.14953, 'lon': -90.04898}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', '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': 30.26715, 'lon': -97.74306}}, {'zip': '75235', 'city': 'Dalllas', 'state': 'Texas', 'country': 'United States', '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': '77008', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', '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': 29.76328, 'lon': -95.36327}}, {'zip': '77566', 'city': 'Lake Jackson', 'state': 'Texas', 'country': 'United States', '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': 29.03386, 'lon': -95.43439}}, {'zip': '77488', 'city': 'Wharton', 'state': 'Texas', 'country': 'United States', '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': 29.31164, 'lon': -96.10274}}, {'zip': '23230', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', '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': 37.55376, 'lon': -77.46026}}, {'zip': '98007', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', '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': 47.61038, 'lon': -122.20068}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', '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': 47.60621, 'lon': -122.33207}}, {'zip': '53227', 'city': 'West Allis', 'state': 'Wisconsin', 'country': 'United States', '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': 43.01668, 'lon': -88.00703}}, {'zip': 'C1058AAJ', 'city': 'Buenos Aires', 'country': 'Argentina', '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': -34.61315, 'lon': -58.37723}}, {'zip': 'V1Y 1Z9', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', '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': 49.88307, 'lon': -119.48568}}, {'zip': 'P2A 3A4', 'city': 'Parry Sound', 'state': 'Ontario', 'country': 'Canada', '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': 45.34732, 'lon': -80.03527}}, {'zip': 'M6J 3S3', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', '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': 43.70643, 'lon': -79.39864}}, {'zip': '20217', 'city': 'Aguascalientes', 'country': 'Mexico', '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': 21.88262, 'lon': -102.2843}}, {'zip': '44630', 'city': 'Guadalajara', 'country': 'Mexico', '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': 20.67738, 'lon': -103.34749}}, {'zip': '37000', 'city': 'León', 'country': 'Mexico', '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': 25.60187, 'lon': -103.47698}}, {'zip': '7810', 'city': 'Mexico City', 'country': 'Mexico', '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': 19.42847, 'lon': -99.12766}}, {'zip': '97000', 'city': 'Mérida', 'country': 'Mexico', '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': 20.967, 'lon': -89.62318}}, {'zip': '64710', 'city': 'Monterrey', 'country': 'Mexico', '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': 25.68435, 'lon': -100.31721}}, {'zip': '58260', 'city': 'Morelia', 'country': 'Mexico', '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': 19.70078, 'lon': -101.18443}}, {'zip': '53160', 'city': 'Tlalnepantla', 'country': 'Mexico', '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': 19.54005, 'lon': -99.19538}}], '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 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