Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT01125358
Status:
TERMINATED
Last Update Posted:
2021-09-14
First Post:
2010-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study in Schizophrenic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C534551', 'term': 'LY 2140023'}]}}, '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': '10 mg LY2140023', 'description': '5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.', 'otherNumAtRisk': 21, 'otherNumAffected': 13, 'seriousNumAtRisk': 21, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '80 mg LY2140023', 'description': '40 mg of LY2140023 orally, twice daily for 6 weeks.', 'otherNumAtRisk': 21, 'otherNumAffected': 13, 'seriousNumAtRisk': 21, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': '160 mg LY2140023', 'description': '80 mg of LY2140023 orally, twice daily for 6 weeks.', 'otherNumAtRisk': 20, 'otherNumAffected': 12, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo orally, twice daily for 6 weeks.', 'otherNumAtRisk': 20, 'otherNumAffected': 9, 'seriousNumAtRisk': 20, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Oral disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Retching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tinea pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blood bilirubin unconjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blood prolactin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Affect lability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Affective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Delusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hair colour changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Psychomotor hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Utility Index (CUI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg LY2140023', 'description': '5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.'}, {'id': 'OG001', 'title': '80 mg LY2140023', 'description': '40 mg of LY2140023 orally, twice daily for 6 weeks.'}, {'id': 'OG002', 'title': '160 mg LY2140023', 'description': '80 mg of LY2140023 orally, twice daily for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.30', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '10.32', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '9.27', 'spread': '0.55', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.02', 'ciLowerLimit': '-3.37', 'ciUpperLimit': '0.00', 'statisticalMethod': 'Multiple Comparisons with The Best (MCB)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'LS mean difference = LS mean of 10 mg LY2140023 - LS mean of 80 mg LY2140023.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.05', 'ciLowerLimit': '-2.42', 'ciUpperLimit': '0.32', 'statisticalMethod': 'Multiple Comparison with The Best (MCB)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'LS mean difference = LS mean of 160 mg LY2140023 - LS mean of 80 mg LY2140023.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Week 6', 'description': 'CUI measures the efficacy (response), tolerability (time on treatment) and safety \\[incidence of adverse events (AEs)\\] by quantifying these 3 attributes and provides a single metric for overall treatment outcome. Each component is given a score ranging from 0 to 5. The CUI Total Score is the sum of the 3 items and ranges from 0 to 15. The greater the CUI Total Score, the more effective the treatment. If a participant experiences a drug-related seizure/death, the safety component is given a score of 0 resulting in an overall CUI Total Score of 0. Analysis of variance (ANOVA) was used to calculate Least Squares (LS) mean and standard error. LS mean values were controlled for treatment, gender and pooled investigators.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug and had CUI Total Score measurement at Week 6.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 Endpoint in the Positive and Negative Syndrome Scale (PANSS) Total Score, Positive Score, Negative Score, and Psychopathology Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg LY2140023', 'description': '5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.'}, {'id': 'OG001', 'title': '80 mg LY2140023', 'description': '40 mg of LY2140023 orally, twice daily for 6 weeks.'}, {'id': 'OG002', 'title': '160 mg LY2140023', 'description': '80 mg of LY2140023 orally, twice daily for 6 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo orally, twice daily for 6 weeks.'}], 'classes': [{'title': 'PANSS Total Score', 'categories': [{'measurements': [{'value': '-0.49', 'groupId': 'OG000', 'lowerLimit': '-12.37', 'upperLimit': '11.40'}, {'value': '-2.56', 'groupId': 'OG001', 'lowerLimit': '-12.32', 'upperLimit': '7.20'}, {'value': '1.40', 'groupId': 'OG002', 'lowerLimit': '-9.64', 'upperLimit': '12.44'}, {'value': '9.35', 'groupId': 'OG003', 'lowerLimit': '-1.80', 'upperLimit': '20.51'}]}]}, {'title': 'PANSS Positive Subscore (n=19, 21, 20, 20)', 'categories': [{'measurements': [{'value': '0.33', 'groupId': 'OG000', 'lowerLimit': '-2.80', 'upperLimit': '3.45'}, {'value': '-2.30', 'groupId': 'OG001', 'lowerLimit': '-4.90', 'upperLimit': '0.30'}, {'value': '-0.05', 'groupId': 'OG002', 'lowerLimit': '-2.93', 'upperLimit': '2.82'}, {'value': '1.93', 'groupId': 'OG003', 'lowerLimit': '-1.00', 'upperLimit': '4.85'}]}]}, {'title': 'PANSS Negative Subscore', 'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000', 'lowerLimit': '-3.20', 'upperLimit': '3.67'}, {'value': '-0.22', 'groupId': 'OG001', 'lowerLimit': '-3.03', 'upperLimit': '2.58'}, {'value': '0.33', 'groupId': 'OG002', 'lowerLimit': '-2.84', 'upperLimit': '3.50'}, {'value': '2.70', 'groupId': 'OG003', 'lowerLimit': '-0.50', 'upperLimit': '5.90'}]}]}, {'title': 'PANSS General Psychopathology Subscore', 'categories': [{'measurements': [{'value': '-0.88', 'groupId': 'OG000', 'lowerLimit': '-7.05', 'upperLimit': '5.30'}, {'value': '-0.31', 'groupId': 'OG001', 'lowerLimit': '-5.35', 'upperLimit': '4.72'}, {'value': '1.18', 'groupId': 'OG002', 'lowerLimit': '-4.59', 'upperLimit': '6.94'}, {'value': '4.79', 'groupId': 'OG003', 'lowerLimit': '-1.03', 'upperLimit': '10.60'}]}]}], 'analyses': [{'pValue': '0.222', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.84', 'ciLowerLimit': '-25.80', 'ciUpperLimit': '6.12', 'pValueComment': 'P-value is for PANSS Total Score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.96', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.105', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.91', 'ciLowerLimit': '-26.42', 'ciUpperLimit': '2.60', 'pValueComment': 'P-value is for PANSS Total Score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.22', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.308', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.96', 'ciLowerLimit': '-23.46', 'ciUpperLimit': '7.55', 'pValueComment': 'P-value is for PANSS Total Score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.73', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.441', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.60', 'ciLowerLimit': '-5.74', 'ciUpperLimit': '2.54', 'pValueComment': 'P-value is for PANSS Positive Subscore.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.06', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.030', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '-4.22', 'ciLowerLimit': '-8.01', 'ciUpperLimit': '-0.44', 'pValueComment': 'P-value is for PANSS Positive Subscore.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.88', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.323', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.98', 'ciLowerLimit': '-5.96', 'ciUpperLimit': '2.01', 'pValueComment': 'P-value is for PANSS Positive Subscore.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.98', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.285', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.46', 'ciLowerLimit': '-7.05', 'ciUpperLimit': '2.12', 'pValueComment': 'P-value is for PANSS Negative Subscore.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.28', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.166', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.92', 'ciLowerLimit': '-7.10', 'ciUpperLimit': '1.26', 'pValueComment': 'P-value is for PANSS Negative Subscore.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.07', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.286', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.37', 'ciLowerLimit': '-6.79', 'ciUpperLimit': '2.05', 'pValueComment': 'P-value is for PANSS Negative Subscore.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.20', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.177', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.67', 'ciLowerLimit': '-13.96', 'ciUpperLimit': '2.63', 'pValueComment': 'P-value is for PANSS General Psychopathology Subscore.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.14', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.178', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.10', 'ciLowerLimit': '-12.60', 'ciUpperLimit': '2.40', 'pValueComment': 'P-value is for PANSS General Psychopathology Subscore.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.74', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.377', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.61', 'ciLowerLimit': '-11.72', 'ciUpperLimit': '4.51', 'pValueComment': 'P-value is for PANSS General Psychopathology Subscore.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.05', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'The PANSS consists of 30 items and 3 subscales designed to measure severity of psychopathology in schizophrenia. The PANSS Positive Subscale and the PANSS Negative Subscale each contain 7 items, and the remaining 16 items make up the PANSS General Psychopathology Subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). The PANSS Total Score is the sum of the 30 items (range from 30 to 210). The PANSS Positive Subscale and PANSS Negative Subscale scores each range from 7 to 49. The PANSS General Psychopathology Subscale score ranges from 16 to 112. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment\\*visit and baseline\\*visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline PANSS measurement. Placebo responder (defined as ≥25% improvement in the PANSS Total Score from the start of placebo lead-in period to the end of placebo lead-in period) was excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 Endpoint in the Clinical Global Impression-Severity Scale (CGI-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg LY2140023', 'description': '5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.'}, {'id': 'OG001', 'title': '80 mg LY2140023', 'description': '40 mg of LY2140023 orally, twice daily for 6 weeks.'}, {'id': 'OG002', 'title': '160 mg LY2140023', 'description': '80 mg of LY2140023 orally, twice daily for 6 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo orally, twice daily for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.62', 'groupId': 'OG000', 'lowerLimit': '-0.11', 'upperLimit': '1.34'}, {'value': '-0.49', 'groupId': 'OG001', 'lowerLimit': '-1.09', 'upperLimit': '0.11'}, {'value': '0.14', 'groupId': 'OG002', 'lowerLimit': '-0.52', 'upperLimit': '0.81'}, {'value': '-0.25', 'groupId': 'OG003', 'lowerLimit': '-0.93', 'upperLimit': '0.42'}]}]}], 'analyses': [{'pValue': '0.077', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '1.83', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.48', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.592', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-1.12', 'ciUpperLimit': '0.65', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.44', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.395', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '1.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.46', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'The CGI-S instrument is used to record the severity of mental illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment\\*visit and baseline\\*visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline CGI-S measurement. Placebo responder (defined as ≥25% improvement in the PANSS Total Score from the start of placebo lead-in period to the end of placebo lead-in period) was excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 Endpoint in the 16-item Negative Symptoms Assessment (NSA-16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg LY2140023', 'description': '5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.'}, {'id': 'OG001', 'title': '80 mg LY2140023', 'description': '40 mg of LY2140023 orally, twice daily for 6 weeks.'}, {'id': 'OG002', 'title': '160 mg LY2140023', 'description': '80 mg of LY2140023 orally, twice daily for 6 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo orally, twice daily for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.42', 'groupId': 'OG000', 'lowerLimit': '-3.38', 'upperLimit': '10.22'}, {'value': '-0.40', 'groupId': 'OG001', 'lowerLimit': '-6.41', 'upperLimit': '5.60'}, {'value': '-6.31', 'groupId': 'OG002', 'lowerLimit': '-13.16', 'upperLimit': '0.53'}, {'value': '-1.22', 'groupId': 'OG003', 'lowerLimit': '-7.76', 'upperLimit': '5.33'}]}]}], 'analyses': [{'pValue': '0.306', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.64', 'ciLowerLimit': '-4.37', 'ciUpperLimit': '13.65', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.49', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.849', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '-7.74', 'ciUpperLimit': '9.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.26', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.259', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '-5.09', 'ciLowerLimit': '-14.05', 'ciUpperLimit': '3.86', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.46', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'The NSA-16 scale is used to help clinicians rate behaviors (not psychopathology) commonly associated with negative symptoms of schizophrenia. The scale rates participants on 16 "anchors". Each item ("anchor") is rated from 1 (better) to 6 (worse). The NSA-16 Total Score is the sum of the 16 specific items and ranges from 16 to 96. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment\\*visit and baseline\\*visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline NSA-16 Total Score measurement. Placebo responder (defined as ≥25% improvement in the PANSS Total Score from the start of placebo lead-in period to the end of placebo lead-in period) was excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Treatment-Emergent Suicidal Ideation and Behavior Based on the Columbia Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg LY2140023', 'description': '5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.'}, {'id': 'OG001', 'title': '80 mg LY2140023', 'description': '40 mg of LY2140023 orally, twice daily for 6 weeks.'}, {'id': 'OG002', 'title': '160 mg LY2140023', 'description': '80 mg of LY2140023 orally, twice daily for 6 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo orally, twice daily for 6 weeks.'}], 'classes': [{'title': 'Treatment-Emergent Suicidal Ideation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Treatment-Emergent Suicidal Behavior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 6', 'description': 'Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. 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. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, non-fatal suicide attempt, and completed suicide. The number of participants with statistically significant changes of the C-SSRS was the number of participants with a treatment-emergent suicidal ideation and behavior (an increase in suicidal behavior or ideation over lead-in baseline.)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline C-SSRS measurements.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Discontinued (Rate of Discontinuation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg LY2140023', 'description': '5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.'}, {'id': 'OG001', 'title': '80 mg LY2140023', 'description': '40 mg of LY2140023 orally, twice daily for 6 weeks.'}, {'id': 'OG002', 'title': '160 mg LY2140023', 'description': '80 mg of LY2140023 orally, twice daily for 6 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo orally, twice daily for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '19.0', 'groupId': 'OG001'}, {'value': '45.0', 'groupId': 'OG002'}, {'value': '40.0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.354', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.181', 'groupIds': ['OG001', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '>0.999', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 6', 'description': 'Rate of discontinuation was calculated as the number of participants who discontinued from study due to any reason divided by the total number of participants who received study drug, then multiplied by 100.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '10 mg LY2140023', 'description': '5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.'}, {'id': 'FG001', 'title': '80 mg LY2140023', 'description': '40 mg of LY2140023 orally, twice daily for 6 weeks.'}, {'id': 'FG002', 'title': '160 mg LY2140023', 'description': '80 mg of LY2140023 orally, twice daily for 6 weeks.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Placebo orally, twice daily for 6 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'Placebo Responder', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Perceived Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'This study consisted of a 1-week placebo lead-in period and a 6-week randomized, double-blind treatment period. Placebo responder is defined as ≥25% improvement in Positive and Negative Syndrome Scale (PANSS) Total Score from the start of placebo lead-in period to the end of placebo lead-in period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '10 mg LY2140023', 'description': '5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks.'}, {'id': 'BG001', 'title': '80 mg LY2140023', 'description': '40 mg of LY2140023 orally, twice daily for 6 weeks.'}, {'id': 'BG002', 'title': '160 mg LY2140023', 'description': '80 mg of LY2140023 orally, twice daily for 6 weeks.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo orally, twice daily for 6 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.99', 'spread': '10.98', 'groupId': 'BG000'}, {'value': '42.03', 'spread': '10.41', 'groupId': 'BG001'}, {'value': '43.16', 'spread': '10.33', 'groupId': 'BG002'}, {'value': '38.34', 'spread': '9.91', 'groupId': 'BG003'}, {'value': '41.14', 'spread': '10.38', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}]}, {'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All Randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'whyStopped': 'The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'dispFirstSubmitDate': '2013-01-11', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-17', 'studyFirstSubmitDate': '2010-05-17', 'dispFirstSubmitQcDate': '2013-01-11', 'resultsFirstSubmitDate': '2021-08-17', 'studyFirstSubmitQcDate': '2010-05-17', 'dispFirstPostDateStruct': {'date': '2013-01-21', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-17', 'studyFirstPostDateStruct': {'date': '2010-05-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Utility Index (CUI)', 'timeFrame': 'Baseline through Week 6', 'description': 'CUI measures the efficacy (response), tolerability (time on treatment) and safety \\[incidence of adverse events (AEs)\\] by quantifying these 3 attributes and provides a single metric for overall treatment outcome. Each component is given a score ranging from 0 to 5. The CUI Total Score is the sum of the 3 items and ranges from 0 to 15. The greater the CUI Total Score, the more effective the treatment. If a participant experiences a drug-related seizure/death, the safety component is given a score of 0 resulting in an overall CUI Total Score of 0. Analysis of variance (ANOVA) was used to calculate Least Squares (LS) mean and standard error. LS mean values were controlled for treatment, gender and pooled investigators.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 6 Endpoint in the Positive and Negative Syndrome Scale (PANSS) Total Score, Positive Score, Negative Score, and Psychopathology Subscale', 'timeFrame': 'Baseline, Week 6', 'description': 'The PANSS consists of 30 items and 3 subscales designed to measure severity of psychopathology in schizophrenia. The PANSS Positive Subscale and the PANSS Negative Subscale each contain 7 items, and the remaining 16 items make up the PANSS General Psychopathology Subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). The PANSS Total Score is the sum of the 30 items (range from 30 to 210). The PANSS Positive Subscale and PANSS Negative Subscale scores each range from 7 to 49. The PANSS General Psychopathology Subscale score ranges from 16 to 112. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment\\*visit and baseline\\*visit.'}, {'measure': 'Change From Baseline to Week 6 Endpoint in the Clinical Global Impression-Severity Scale (CGI-S)', 'timeFrame': 'Baseline, Week 6', 'description': 'The CGI-S instrument is used to record the severity of mental illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment\\*visit and baseline\\*visit.'}, {'measure': 'Change From Baseline to Week 6 Endpoint in the 16-item Negative Symptoms Assessment (NSA-16)', 'timeFrame': 'Baseline, Week 6', 'description': 'The NSA-16 scale is used to help clinicians rate behaviors (not psychopathology) commonly associated with negative symptoms of schizophrenia. The scale rates participants on 16 "anchors". Each item ("anchor") is rated from 1 (better) to 6 (worse). The NSA-16 Total Score is the sum of the 16 specific items and ranges from 16 to 96. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment\\*visit and baseline\\*visit.'}, {'measure': 'The Number of Participants With Treatment-Emergent Suicidal Ideation and Behavior Based on the Columbia Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Baseline up to Week 6', 'description': 'Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. 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. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, non-fatal suicide attempt, and completed suicide. The number of participants with statistically significant changes of the C-SSRS was the number of participants with a treatment-emergent suicidal ideation and behavior (an increase in suicidal behavior or ideation over lead-in baseline.)'}, {'measure': 'Percentage of Participants Who Discontinued (Rate of Discontinuation)', 'timeFrame': 'Baseline through Week 6', 'description': 'Rate of discontinuation was calculated as the number of participants who discontinued from study due to any reason divided by the total number of participants who received study drug, then multiplied by 100.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '25890643', 'type': 'DERIVED', 'citation': 'Kinon BJ, Millen BA, Zhang L, McKinzie DL. Exploratory analysis for a targeted patient population responsive to the metabotropic glutamate 2/3 receptor agonist pomaglumetad methionil in schizophrenia. Biol Psychiatry. 2015 Dec 1;78(11):754-62. doi: 10.1016/j.biopsych.2015.03.016. Epub 2015 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to compare 3 doses of LY2140023 for the treatment of schizophrenia as assessed at endpoint (up to 7 weeks) using the Clinical Utility Index (CUI), a measure of efficacy, safety, and tolerability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR; APA 2000) (Disorganized, 295.10; Catatonic, 295.20; Paranoid 295.30; or Undifferentiated, 295.90) and confirmed by the Structured Clinical Interview for DSM-IV-TR (SCID)\n* Non pregnant female participants who agree to use acceptable birth control\n* At entry to the study must be considered moderately ill in the opinion of the investigator\n* 1 year history of Schizophrenia prior to entering the study\n* At study entry participants with a history of antipsychotic treatment must have a lifetime history of at least one hospitalization for the treatment of schizophrenia, not including the hospitalization required for study based on the investigator's clinical judgment. Participants who have never taken antipsychotic treatment may enter the study even without a history of hospitalization\n* At study entry participants with a history of antipsychotic treatment must have a history of at least one episode of illness exacerbation requiring an intensification of treatment intervention or care in the last 2 years, not including the present episode of illness. Participants who have never taken antipsychotic treatment may enter the study without a past history of illness exacerbation and intensification of treatment in the last 2 years\n* At study entry participants must have experienced an exacerbation of illness within the 4 weeks prior to entering the study, leading to an intensification of psychiatric care in the opinion of the investigator. If exacerbation occurs in participants who are presently hospitalized, the participants must not have been hospitalized longer than 60 days at entry of the study\n\nExclusion Criteria:\n\n* Participated in any clinical trial with any pharmacological treatment intervention for which they received a study-related medication in the 6 months prior to visit 1\n* Previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity\n* Have any known history of receiving treatment with clozapine at any dose, as determined at baseline\n* Have received treatment with a depot formulation of an antipsychotic medication within the 6 months prior entering the study\n* Participants who are currently suicidal\n* Females who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study\n* Participants with uncorrected narrow-angle glaucoma, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, untreated thyroid condition or other serious or unstable illnesses\n* Have a history of one or more seizures, except for those who experienced a single simple febrile seizure between ages 6 months and 5 years\n* Participants are excluded if their biological father, mother, brother, sister, or child has a history of idiopathic epilepsy\n* Within 1 year of study enrollment, participants have a history of central nervous system infection, uncontrolled migraine, transient ischemic attack (TIA), or head trauma with loss of consciousness or a post-concussive\n* Participants are excluded if they have a lifetime history of any of the following:\n\n * head trauma, stroke, or central nervous system (CNS) infection with persistent neurological deficit (focal or diffuse);\n * brain surgery;\n * an electroencephalogram with paroxysmal (epileptiform) activity, or\n * brain structural lesion, including developmental abnormalities, as determined by examination or previous neuroimaging studies that are consistent with a diagnosable neurological disease or syndrome\n* Electroconvulsive therapy (ECT) within 3 months of entering the study or who will have ECT at any time during the study\n* Leukopenia\n* Medical history of Human Immunodeficiency Virus positive (HIV+) status\n* Higher than normal blood prolactin levels\n* Certain electrocardiogram results"}, 'identificationModule': {'nctId': 'NCT01125358', 'briefTitle': 'A Study in Schizophrenic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Denovo Biopharma LLC'}, 'officialTitle': 'A Multicenter, Double-Blind, Placebo-Controlled Study of 3 Doses of LY2140023 in Patients With DSM-IV-TR Schizophrenia', 'orgStudyIdInfo': {'id': '13560'}, 'secondaryIdInfos': [{'id': 'H8Y-JE-HBDC', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '10 milligrams (mg) LY2140023', 'interventionNames': ['Drug: LY2140023']}, {'type': 'EXPERIMENTAL', 'label': '80 mg LY2140023', 'interventionNames': ['Drug: LY2140023']}, {'type': 'EXPERIMENTAL', 'label': '160 mg LY2140023', 'interventionNames': ['Drug: LY2140023']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY2140023', 'type': 'DRUG', 'description': 'Administered orally, twice daily for up to 7 weeks of treatment', 'armGroupLabels': ['10 milligrams (mg) LY2140023', '160 mg LY2140023', '80 mg LY2140023']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally, twice daily for up to 7 weeks of treatment', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '470-1168', 'city': 'Aichi', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'zip': '216-0003', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '861-0002', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '625-8502', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '384-8540', 'city': 'Nagano', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'zip': '856-0847', 'city': 'Nagasaki', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'zip': '634-8522', 'city': 'Nara', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.68505, 'lon': 135.80485}}, {'zip': '569-1041', 'city': 'Osaka', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '842-0192', 'city': 'Saga', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}, {'zip': '114-0024', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '939-8073', 'city': 'Toyama', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}, {'zip': '759-6321', 'city': 'Yamaguchi', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.18333, 'lon': 131.46667}}, {'zip': '410-719', 'city': 'Goyang-si', 'country': 'South Korea', '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': 37.65639, 'lon': 126.835}}, {'zip': '400-711', 'city': 'Incheon', 'country': 'South Korea', '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': 37.45646, 'lon': 126.70515}}, {'zip': '520-833', 'city': 'Naju', 'country': 'South Korea', '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': 35.0292, 'lon': 126.7175}}, {'zip': '150-713', 'city': 'Seoul', 'country': 'South Korea', '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': 37.566, 'lon': 126.9784}}, {'zip': '442-723', 'city': 'Suwon', 'country': 'South Korea', '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': 37.29111, 'lon': 127.00889}}, {'zip': '446-769', 'city': 'Yŏngin', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.8553, 'lon': 126.9537}}, {'zip': '50550', 'city': 'Changhua', 'country': 'Taiwan', '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': 24.0692, 'lon': 120.5512}}, {'zip': '802', 'city': 'Hsinchu', 'country': 'Taiwan', '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': 24.80361, 'lon': 120.96861}}, {'zip': '110', 'city': 'Taipei', 'country': 'Taiwan', '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': 25.05306, 'lon': 121.52639}}, {'zip': '114', 'city': 'Taipei', 'country': 'Taiwan', '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': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4459 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Denovo Biopharma LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}