Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:29 PM
Study NCT ID:
NCT01328093
Status:
TERMINATED
Last Update Posted:
2022-09-07
First Post:
2011-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Comparison Study of LY2140023 and Aripiprazole in Schizophrenia 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'}, {'id': 'D000068180', 'term': 'Aripiprazole'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated early. 97% of participants had completed or discontinued from the DB Phase prior to termination. Outcome measure populations excluded data from a site that had significant GCP noncompliance issues (3 participants).'}}, 'adverseEventsModule': {'description': 'Adverse events were reported for all randomized participants who received at least 1 dose of study drug, excluding participants from a Good Clinical Practice (GCP) noncompliant study site.', 'eventGroups': [{'id': 'EG000', 'title': 'LY2140023-DB', 'description': '40 milligrams (mg) LY2140023 administered orally, twice daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 20 mg twice daily or 80 mg twice daily.', 'otherNumAtRisk': 511, 'otherNumAffected': 358, 'seriousNumAtRisk': 511, 'seriousNumAffected': 42}, {'id': 'EG001', 'title': 'Aripiprazole-DB', 'description': '15 mg aripiprazole administered orally, once daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 10 mg once daily or 30 mg once daily.', 'otherNumAtRisk': 161, 'otherNumAffected': 107, 'seriousNumAtRisk': 161, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'LY2140023-OL', 'description': '40mg LY2140023 administered orally, twice daily for 28 weeks during the Open -Label (OL) Phase, following the treatment with either 40 mg LY2140023 or 15 mg aripiprazole during the Double-Blind Phase. Dose was adjustable to 20 mg twice daily or 80 mg twice daily.', 'otherNumAtRisk': 270, 'otherNumAffected': 112, 'seriousNumAtRisk': 270, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Left atrial dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 112, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 58, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Therapeutic response unexpected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 40, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Maternal exposure during pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 30, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Muscle tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Extrapyramidal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 69, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Myoclonus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bruxism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hallucination, auditory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 53, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 6, 'numAffected': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Menopause', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Female sterilisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Wolff-parkinson-white syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Maternal exposure during pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Convulsion', 'notes': 'Event was determined not to be a seizure by Seizure Adjudication Committee.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dystonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Anxiety disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Completed suicide', 'notes': 'Event resulted in death.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Delusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hallucination, auditory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Homicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pulmonary thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to 24 Weeks in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2140023-DB', 'description': '40 milligrams (mg) LY2140023 administered orally, twice daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 20 mg twice daily or 80 mg twice daily.'}, {'id': 'OG001', 'title': 'Aripiprazole-DB', 'description': '15 mg aripiprazole administered orally, once daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 10 mg once daily or 30 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.8', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '-3.2', 'pValueComment': 'No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.7', 'statisticalMethod': 'Type III Tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks', 'description': 'Mixed model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigator, visit, prior olanzapine use, treatment-by-visit interaction and baseline-by-visit interaction.', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had baseline and at least one post-baseline weight measurement, excluding participants from the excluded study site.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinically Significant Weight Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '488', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2140023-DB', 'description': '40 milligrams (mg) LY2140023 administered orally, twice daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 20 mg twice daily or 80 mg twice daily.'}, {'id': 'OG001', 'title': 'Aripiprazole-DB', 'description': '15 mg aripiprazole administered orally, once daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 10 mg once daily or 30 mg once daily.'}], 'classes': [{'title': '≥7% Increase', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}]}]}, {'title': '≥7% Decrease', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.110', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for ≥7% increase.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for ≥7% decrease.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 24 weeks', 'description': 'Clinically significant change in body weight is defined as either an increase or decrease in weight of ≥7% from baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline weight measurement, excluding participants from the excluded study site.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline up to 24 Weeks in Barnes Akathisia Scale (BAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2140023-DB', 'description': '40 milligrams (mg) LY2140023 administered orally, twice daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 20 mg twice daily or 80 mg twice daily.'}, {'id': 'OG001', 'title': 'Aripiprazole-DB', 'description': '15 mg aripiprazole administered orally, once daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 10 mg once daily or 30 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.353', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '0.04', 'pValueComment': 'No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.04', 'statisticalMethod': 'Type III Tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks', 'description': 'The BAS is a 4-item instrument that evaluates akathisia associated with use of antipsychotic medications. Item 4 Global Clinical Assessment of Akathisia is rated on a 6- point scale, with scores range from 0 (no symptoms) to 5 (increased severity of symptoms); Only Item 4 was analyzed and presented. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline BAS global score measurement, excluding participants from the excluded study site.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline up to 24 Weeks in Simpson-Angus Scale (SAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2140023-DB', 'description': '40 milligrams (mg) LY2140023 administered orally, twice daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 20 mg twice daily or 80 mg twice daily.'}, {'id': 'OG001', 'title': 'Aripiprazole-DB', 'description': '15 mg aripiprazole administered orally, once daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 10 mg once daily or 30 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.698', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '0.03', 'pValueComment': 'No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'statisticalMethod': 'Type III Tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks', 'description': 'The SAS is used to measure Parkinsonian-type symptoms in participants exposed to antipsychotics. SAS consists of 10 items, each rated on a 5-point scale: 0 (complete absence of the condition) to 4 (presence of the condition in extreme form). The SAS Total Score is obtained by adding the ten items, and ranges from 0 to 40. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment by-visit-interaction and baseline-by-visit interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline SAS total score measurement, excluding participants from the excluded study site.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline up to 24 Weeks in Abnormal Involuntary Movement Scale (AIMS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2140023-DB', 'description': '40 milligrams (mg) LY2140023 administered orally, twice daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 20 mg twice daily or 80 mg twice daily.'}, {'id': 'OG001', 'title': 'Aripiprazole-DB', 'description': '15 mg aripiprazole administered orally, once daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 10 mg once daily or 30 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.924', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '-0.01', 'pValueComment': 'No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.07', 'statisticalMethod': 'Type III Tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks', 'description': 'AIMS is a 12-item scale designed to record the occurrence of dyskinetic movements. Items 1 to 10 are rated on a 5- point scale: 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Items 11 and 12 are yes/no questions regarding the dental condition of a participant. The AIMS 1-7 Total Score is the sum of Items 1 through 7 of the AIMS, and ranges from 0 to 28. Higher scores indicate greater severity of illness. Only AIMS 1-7 Total Score was analyzed and presented. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline AIMS 1-7 Total Score measurement, excluding participants from the excluded study site.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline up to 24 Weeks in Positive and Negative Syndrome Scale (PANSS) Total and Subscale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2140023-DB', 'description': '40 milligrams (mg) LY2140023 administered orally, twice daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 20 mg twice daily or 80 mg twice daily.'}, {'id': 'OG001', 'title': 'Aripiprazole-DB', 'description': '15 mg aripiprazole administered orally, once daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 10 mg once daily or 30 mg once daily.'}], 'classes': [{'title': 'PANSS Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.03', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '-15.58', 'spread': '1.58', 'groupId': 'OG001'}]}]}, {'title': 'PANSS Positive Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.40', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '-4.62', 'spread': '0.50', 'groupId': 'OG001'}]}]}, {'title': 'PANSS Negative Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.98', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '-3.34', 'spread': '0.48', 'groupId': 'OG001'}]}]}, {'title': 'PANSS General Psychopathology Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.80', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-7.85', 'spread': '0.89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.045', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '3.55', 'pValueComment': 'P-value is for PANSS Total Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.77', 'statisticalMethod': 'Type III Tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.032', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '1.21', 'pValueComment': 'P-value is for PANSS Positive Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.56', 'statisticalMethod': 'Type III Tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.509', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '0.36', 'pValueComment': 'P-value is for PANSS Negative Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.54', 'statisticalMethod': 'Type III Tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.040', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '2.05', 'pValueComment': 'P-value is for PANSS General Psychopathology Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.00', 'statisticalMethod': 'Type III Tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks', 'description': 'The PANSS consists of 30 items and 3 subscales and is 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, with scores 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 adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline PANSS measurement, excluding participants from the excluded study site.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline up to 24 Weeks in EuroQol-5 Dimensions Questionnaire (EQ-5D) Visual Analog Scale (VAS) Health State Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2140023-DB', 'description': '40 milligrams (mg) LY2140023 administered orally, twice daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 20 mg twice daily or 80 mg twice daily.'}, {'id': 'OG001', 'title': 'Aripiprazole-DB', 'description': '15 mg aripiprazole administered orally, once daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 10 mg once daily or 30 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.601', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '1.1', 'pValueComment': 'No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.1', 'statisticalMethod': 'Type III Tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks', 'description': 'The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument that contains 2 parts: a health status profile and a visual analog scale (VAS) to rate global health-related quality of life. VAS health state scores range from 0 (worst imaginable health state) to 100 (best imaginable health state). The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline VAS health state measurement, excluding participants from the excluded study site.'}, {'type': 'SECONDARY', 'title': 'Schizophrenia Resource Utilization Module (S-RUM) - Number of Emergency Room (ER) or Equivalent Facility Visits and Outpatient Medical Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2140023-DB', 'description': '40 milligrams (mg) LY2140023 administered orally, twice daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 20 mg twice daily or 80 mg twice daily.'}, {'id': 'OG001', 'title': 'Aripiprazole-DB', 'description': '15 mg aripiprazole administered orally, once daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 10 mg once daily or 30 mg once daily.'}], 'classes': [{'title': 'ER/Facility (Psych) visits', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'ER/Facility (Non-Psych) visits', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Outpatient (Non-Psych or Dentist) visits', 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.322', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '-0.02', 'pValueComment': 'P-value is for ER/Facility (Psych) visits. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.02', 'statisticalMethod': 'Type III Tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.099', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '-0.04', 'pValueComment': 'P-value is for ER/Facility (Non-Psych) visits. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.02', 'statisticalMethod': 'Type III Tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.787', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '0.02', 'pValueComment': 'P-value is for Outpatient (Non-Psych or Dentist) visits. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.07', 'statisticalMethod': 'Type III Tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 24 weeks', 'description': "The S-RUM is a 31-item questionnaire to assess the participant's occupation (work and home), living arrangements, encounters with law enforcement, victimization, ER visits, and outpatient medical visits for a specified period of time. Item 1 asks about the number of ER or equivalent facility visits a participant had for psychiatric (psych) illness. Item 2 asks about the number of ER or equivalent facility visits a participant had for non-psychiatric (non-psych) illness or injury. Item 5 asks about the number of outpatient visits to other physicians (not psychiatrists or dentists). Analysis of variance (ANOVA) was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for pooled investigator, gender and treatment.", 'unitOfMeasure': 'visits', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug and had S-RUM assessment, excluding participants from the excluded study site. Last observation carried forward (LOCF) principle was used.'}, {'type': 'SECONDARY', 'title': 'Schizophrenia Resource Use Module (S-RUM) - Number of Sessions With a Psychiatrist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2140023-DB', 'description': '40 milligrams (mg) LY2140023 administered orally, twice daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 20 mg twice daily or 80 mg twice daily.'}, {'id': 'OG001', 'title': 'Aripiprazole-DB', 'description': '15 mg aripiprazole administered orally, once daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 10 mg once daily or 30 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.39', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.892', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '0.02', 'pValueComment': 'No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'statisticalMethod': 'Type III Tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 24 weeks', 'description': "The S-RUM is a 31-item questionnaire to assess the participant's occupation (work and home), living arrangements, encounters with law enforcement, victimization, emergency room (ER) visits, and outpatient medical visits for a specified period of time. Item 4 asks about the number of sessions with a psychiatrist a participant had. Analysis of variance (ANOVA) was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for pooled investigator, gender and treatment.", 'unitOfMeasure': 'sessions', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug and had S-RUM assessment, excluding participants from the excluded study site. Last observation carried forward (LOCF) principle was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline up to 24 Weeks in Subjective Well-Being Under Neuroleptic Treatment Scale- Short Form (SWN-SF) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2140023-DB', 'description': '40 milligrams (mg) LY2140023 administered orally, twice daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 20 mg twice daily or 80 mg twice daily.'}, {'id': 'OG001', 'title': 'Aripiprazole-DB', 'description': '15 mg aripiprazole administered orally, once daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 10 mg once daily or 30 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.630', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '-0.8', 'pValueComment': 'No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.6', 'statisticalMethod': 'Type III Tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks', 'description': 'The SWN-SF measures subjective well-being of the participant for the previous 7 days. The 20-item scale covers 5 health domains (subscales; 4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). Each of the 5 subscale scores range from 4 to 24. SWN-SF Total Scores range from 20 to 120. Higher scores indicate greater well-being. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline SWN-SF Total Score measurement, excluding participants from the excluded study site.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline up to 24 Weeks in Personal and Social Performance (PSP) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2140023-DB', 'description': '40 milligrams (mg) LY2140023 administered orally, twice daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 20 mg twice daily or 80 mg twice daily.'}, {'id': 'OG001', 'title': 'Aripiprazole-DB', 'description': '15 mg aripiprazole administered orally, once daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 10 mg once daily or 30 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.679', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '-0.5', 'pValueComment': 'No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.2', 'statisticalMethod': 'Type III Tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks', 'description': "The PSP scale is a 100-point (minimum 1, maximum 100), single item, clinician-rated scale to assess a participant's overall functioning, including personal and social relationships, socially useful activities, self-care, and disturbing and aggressive behaviors. Higher scores indicate a higher level of functioning. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline PSP measurement, excluding participants from the excluded study site.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline up to 24 Weeks in Clinical Global Impression-Severity Scale (CGI-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2140023-DB', 'description': '40 milligrams (mg) LY2140023 administered orally, twice daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 20 mg twice daily or 80 mg twice daily.'}, {'id': 'OG001', 'title': 'Aripiprazole-DB', 'description': '15 mg aripiprazole administered orally, once daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 10 mg once daily or 30 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.51', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.69', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.055', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '0.17', 'pValueComment': 'No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'statisticalMethod': 'Type III Tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks', '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 standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline CGI-S measurement, excluding participants from the excluded study site.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline up to 24 Weeks in 16-Item Negative Symptom Assessment (NSA-16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2140023-DB', 'description': '40 milligrams (mg) LY2140023 administered orally, twice daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 20 mg twice daily or 80 mg twice daily.'}, {'id': 'OG001', 'title': 'Aripiprazole-DB', 'description': '15 mg aripiprazole administered orally, once daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 10 mg once daily or 30 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.22', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '-6.37', 'spread': '1.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.891', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '0.15', 'pValueComment': 'No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.11', 'statisticalMethod': 'Type III Tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks', '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 standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline NSA-16 Total Score measurement, excluding participants from the excluded study site.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With 30% or Greater Decrease in Positive and Negative Syndrome Scale (PANSS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2140023-DB', 'description': '40 milligrams (mg) LY2140023 administered orally, twice daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 20 mg twice daily or 80 mg twice daily.'}, {'id': 'OG001', 'title': 'Aripiprazole-DB', 'description': '15 mg aripiprazole administered orally, once daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 10 mg once daily or 30 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 24 weeks', 'description': 'The PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (absence of symptoms) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS Total Score and ranges from 30 to 210. Higher scores indicate greater severity of illness. Data presented are the number of participants with 30% or greater decrease from baseline in PANSS Total score.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline PANSS measurement, excluding participants from the excluded study site. Last observation carried forward (LOCF) principle was used.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Suicidal Behaviors and Ideations Measured by Columbia Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '488', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2140023-DB', 'description': '40 milligrams (mg) LY2140023 administered orally, twice daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 20 mg twice daily or 80 mg twice daily.'}, {'id': 'OG001', 'title': 'Aripiprazole-DB', 'description': '15 mg aripiprazole administered orally, once daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 10 mg once daily or 30 mg once daily.'}], 'classes': [{'title': 'Treatment-Emergent Suicidal Ideation', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-Emergent Suicidal Behavior', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.064', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Treatment-Emergent Suicidal Ideation.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.205', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Treatment-Emergent Suicidal Behavior.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 24 weeks', '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, actual attempt, and completed suicide. Data presented are the number of participants with treatment-emergent suicidal ideation or behavior during the treatment period (with a change from lead-in baseline in C-SSRS).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, had a baseline and at least one post-baseline C-SSRS measurement, excluding participants from the excluded study site.'}, {'type': 'SECONDARY', 'title': 'Time to Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2140023-DB', 'description': '40 milligrams (mg) LY2140023 administered orally, twice daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 20 mg twice daily or 80 mg twice daily.'}, {'id': 'OG001', 'title': 'Aripiprazole-DB', 'description': '15 mg aripiprazole administered orally, once daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 10 mg once daily or 30 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000', 'lowerLimit': '120', 'upperLimit': '158'}, {'value': '169', 'comment': 'The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment.', 'groupId': 'OG001', 'lowerLimit': '131', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization up to 24 weeks', 'description': 'The time to discontinuation due to any reason was defined as the total number of days between randomization and discontinuation date. The time to discontinuation was analyzed using Kaplan-Meier estimated survival curves. Participants who completed the study were considered censored.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population: All randomized participants who received at least one dose of study drug, excluding participants from the excluded study site. Participants who completed the study were considered censored: 229 for LY2140023 group and 84 for Aripiprazole group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LY2140023-DB / LY2140023-OL', 'description': '40 milligrams (mg) LY2140023 administered orally, twice daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 20 mg twice daily or 80 mg twice daily.\n\n40mg LY2140023 administered orally, twice daily for 28 weeks during the Open -Label (OL) Phase. Dose was adjustable to 20 mg twice daily or 80 mg twice daily.'}, {'id': 'FG001', 'title': 'Aripiprazole-DB / LY2140023-OL', 'description': '15 mg aripiprazole administered orally, once daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 10 mg once daily or 30 mg once daily.\n\n40mg LY2140023 administered orally, twice daily for 28 weeks during the Open -Label (OL) Phase. Dose was adjustable to 20 mg twice daily or 80 mg twice daily.'}], 'periods': [{'title': 'Double-Blind Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '516'}, {'groupId': 'FG001', 'numSubjects': '162'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '514'}, {'groupId': 'FG001', 'numSubjects': '161'}]}, {'type': 'Modified Intent-To-Treat (mITT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '511'}, {'groupId': 'FG001', 'numSubjects': '161'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Not all participants entered Open-Label Treatment Phase.', 'groupId': 'FG000', 'numSubjects': '231'}, {'comment': 'Not all participants entered Open-Label Treatment Phase.', 'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '285'}, {'groupId': 'FG001', 'numSubjects': '78'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Scheduling conflict', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Subject is moving or has moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Open-Label Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'Modified Intent-To-Treat (mITT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '197'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '50'}]}], 'dropWithdraws': [{'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Scheduling conflict', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Subject is moving or has moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This study consisted of a 24-week Double-Blind Active Treatment Phase and was followed by a 28-week Open-Label Active Treatment Phase. Modified intent-to-treat (mITT) is all randomized participants who received at least 1 dose of study drug, excluding participants from a Good Clinical Practice (GCP) noncompliant study site.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '672', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LY2140023-DB', 'description': '40 milligrams (mg) LY2140023 administered orally, twice daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 20 mg twice daily or 80 mg twice daily.'}, {'id': 'BG001', 'title': 'Aripiprazole-DB', 'description': '15 mg aripiprazole administered orally, once daily for 24 weeks during the Double-Blind (DB) Phase. Dose was adjustable to 10 mg once daily or 30 mg once daily.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.29', 'spread': '10.86', 'groupId': 'BG000'}, {'value': '42.95', 'spread': '10.95', 'groupId': 'BG001'}, {'value': '42.45', 'spread': '10.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '326', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '432', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '438', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '576', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '238', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '259', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '352', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '341', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '453', 'groupId': 'BG002'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Modified intention-to-treat (mITT) population: All randomized participants who received at least 1 dose of study drug, excluding participants from the excluded study site.'}}, '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': 678}}, 'statusModule': {'whyStopped': 'The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'dispFirstSubmitDate': '2013-01-11', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-15', 'studyFirstSubmitDate': '2011-03-31', 'dispFirstSubmitQcDate': '2013-01-11', 'resultsFirstSubmitDate': '2021-08-17', 'studyFirstSubmitQcDate': '2011-03-31', 'dispFirstPostDateStruct': {'date': '2013-01-21', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-15', 'studyFirstPostDateStruct': {'date': '2011-04-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to 24 Weeks in Body Weight', 'timeFrame': 'Baseline, 24 weeks', 'description': 'Mixed model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigator, visit, prior olanzapine use, treatment-by-visit interaction and baseline-by-visit interaction.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Clinically Significant Weight Change', 'timeFrame': 'Baseline up to 24 weeks', 'description': 'Clinically significant change in body weight is defined as either an increase or decrease in weight of ≥7% from baseline.'}, {'measure': 'Change From Baseline up to 24 Weeks in Barnes Akathisia Scale (BAS)', 'timeFrame': 'Baseline, 24 weeks', 'description': 'The BAS is a 4-item instrument that evaluates akathisia associated with use of antipsychotic medications. Item 4 Global Clinical Assessment of Akathisia is rated on a 6- point scale, with scores range from 0 (no symptoms) to 5 (increased severity of symptoms); Only Item 4 was analyzed and presented. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction.'}, {'measure': 'Change From Baseline up to 24 Weeks in Simpson-Angus Scale (SAS)', 'timeFrame': 'Baseline, 24 weeks', 'description': 'The SAS is used to measure Parkinsonian-type symptoms in participants exposed to antipsychotics. SAS consists of 10 items, each rated on a 5-point scale: 0 (complete absence of the condition) to 4 (presence of the condition in extreme form). The SAS Total Score is obtained by adding the ten items, and ranges from 0 to 40. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment by-visit-interaction and baseline-by-visit interaction.'}, {'measure': 'Change From Baseline up to 24 Weeks in Abnormal Involuntary Movement Scale (AIMS)', 'timeFrame': 'Baseline, 24 weeks', 'description': 'AIMS is a 12-item scale designed to record the occurrence of dyskinetic movements. Items 1 to 10 are rated on a 5- point scale: 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Items 11 and 12 are yes/no questions regarding the dental condition of a participant. The AIMS 1-7 Total Score is the sum of Items 1 through 7 of the AIMS, and ranges from 0 to 28. Higher scores indicate greater severity of illness. Only AIMS 1-7 Total Score was analyzed and presented. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction.'}, {'measure': 'Change From Baseline up to 24 Weeks in Positive and Negative Syndrome Scale (PANSS) Total and Subscale Scores', 'timeFrame': 'Baseline, 24 weeks', 'description': 'The PANSS consists of 30 items and 3 subscales and is 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, with scores 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 adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction.'}, {'measure': 'Change From Baseline up to 24 Weeks in EuroQol-5 Dimensions Questionnaire (EQ-5D) Visual Analog Scale (VAS) Health State Score', 'timeFrame': 'Baseline, 24 weeks', 'description': 'The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument that contains 2 parts: a health status profile and a visual analog scale (VAS) to rate global health-related quality of life. VAS health state scores range from 0 (worst imaginable health state) to 100 (best imaginable health state). The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction.'}, {'measure': 'Schizophrenia Resource Utilization Module (S-RUM) - Number of Emergency Room (ER) or Equivalent Facility Visits and Outpatient Medical Visits', 'timeFrame': 'Baseline to 24 weeks', 'description': "The S-RUM is a 31-item questionnaire to assess the participant's occupation (work and home), living arrangements, encounters with law enforcement, victimization, ER visits, and outpatient medical visits for a specified period of time. Item 1 asks about the number of ER or equivalent facility visits a participant had for psychiatric (psych) illness. Item 2 asks about the number of ER or equivalent facility visits a participant had for non-psychiatric (non-psych) illness or injury. Item 5 asks about the number of outpatient visits to other physicians (not psychiatrists or dentists). Analysis of variance (ANOVA) was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for pooled investigator, gender and treatment."}, {'measure': 'Schizophrenia Resource Use Module (S-RUM) - Number of Sessions With a Psychiatrist', 'timeFrame': 'Baseline to 24 weeks', 'description': "The S-RUM is a 31-item questionnaire to assess the participant's occupation (work and home), living arrangements, encounters with law enforcement, victimization, emergency room (ER) visits, and outpatient medical visits for a specified period of time. Item 4 asks about the number of sessions with a psychiatrist a participant had. Analysis of variance (ANOVA) was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for pooled investigator, gender and treatment."}, {'measure': 'Change From Baseline up to 24 Weeks in Subjective Well-Being Under Neuroleptic Treatment Scale- Short Form (SWN-SF) Total Score', 'timeFrame': 'Baseline, 24 weeks', 'description': 'The SWN-SF measures subjective well-being of the participant for the previous 7 days. The 20-item scale covers 5 health domains (subscales; 4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). Each of the 5 subscale scores range from 4 to 24. SWN-SF Total Scores range from 20 to 120. Higher scores indicate greater well-being. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction.'}, {'measure': 'Change From Baseline up to 24 Weeks in Personal and Social Performance (PSP) Score', 'timeFrame': 'Baseline, 24 weeks', 'description': "The PSP scale is a 100-point (minimum 1, maximum 100), single item, clinician-rated scale to assess a participant's overall functioning, including personal and social relationships, socially useful activities, self-care, and disturbing and aggressive behaviors. Higher scores indicate a higher level of functioning. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction."}, {'measure': 'Change From Baseline up to 24 Weeks in Clinical Global Impression-Severity Scale (CGI-S)', 'timeFrame': 'Baseline, 24 weeks', '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 standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction.'}, {'measure': 'Change From Baseline up to 24 Weeks in 16-Item Negative Symptom Assessment (NSA-16)', 'timeFrame': 'Baseline, 24 weeks', '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 standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigative site, visit, predefined subpopulation, treatment-by-visit interaction and baseline-by-visit interaction.'}, {'measure': 'Number of Participants With 30% or Greater Decrease in Positive and Negative Syndrome Scale (PANSS) Total Score', 'timeFrame': 'Baseline up to 24 weeks', 'description': 'The PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (absence of symptoms) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS Total Score and ranges from 30 to 210. Higher scores indicate greater severity of illness. Data presented are the number of participants with 30% or greater decrease from baseline in PANSS Total score.'}, {'measure': 'Number of Participants With Suicidal Behaviors and Ideations Measured by Columbia Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Baseline to 24 weeks', '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, actual attempt, and completed suicide. Data presented are the number of participants with treatment-emergent suicidal ideation or behavior during the treatment period (with a change from lead-in baseline in C-SSRS).'}, {'measure': 'Time to Discontinuation', 'timeFrame': 'Randomization up to 24 weeks', 'description': 'The time to discontinuation due to any reason was defined as the total number of days between randomization and discontinuation date. The time to discontinuation was analyzed using Kaplan-Meier estimated survival curves. Participants who completed the study were considered censored.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '24772351', 'type': 'DERIVED', 'citation': 'Adams DH, Zhang L, Millen BA, Kinon BJ, Gomez JC. Pomaglumetad Methionil (LY2140023 Monohydrate) and Aripiprazole in Patients with Schizophrenia: A Phase 3, Multicenter, Double-Blind Comparison. Schizophr Res Treatment. 2014;2014:758212. doi: 10.1155/2014/758212. Epub 2014 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether weight gain will be significantly less in LY2140023 than aripiprazole in patients with schizophrenia.', 'detailedDescription': 'The primary objective of this study was to test the hypothesis that mean weight gain, as assessed by change from baseline, would be statistically significantly less for flexibly dosed LY2140023 (20, 40, or 80 mg twice daily \\[BID\\]) than for flexibly dosed aripiprazole (10, 15, or 30 mg/day) in patients with schizophrenia after 24 weeks of double-blind treatment.\n\nThis was a multicenter, randomized, double-blind, Phase 3 study to assess the safety and efficacy of LY2140023 (flexibly dosed between 20 and 80 mg BID) in patients with schizophrenia. An active control, aripiprazole (flexibly dosed between 10 and 30 mg/day), was included for comparison.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of schizophrenia\n* Female participants of childbearing age must test negative for pregnancy at screening and agree to use single, effective, medically acceptable method of birth control\n* Participants must require initiation of or modification to current antipsychotic treatment as outpatients\n* Participants must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures\n* Participants must be able to understand the nature of the study and have given their own informed consent\n\nExclusion Criteria:\n\n* Have been on treatment with aripiprazole in the past 2 months or are aripiprazole nonresponders\n* Participants who are pregnant, nursing, or intend to become pregnant within 30 days of completing the study\n* Hospitalized within 2 weeks of screening or have been hospitalized for an exacerbation of symptoms of schizophrenia with a discharge date in the past 2 months\n* Participants who are actively suicidal\n* Participants with uncorrected narrow-angle glaucoma, history of or current seizure disorder, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, uncontrolled thyroid condition or other serious or unstable illnesses\n* Participants who have had electroconvulsive therapy (ECT) within 3 months prior to screening or will have ECT at any time during the study\n* Participants with known medical history of Human Immunodeficiency Virus positive (HIV+) status\n* Test positive for (1) Hepatitis C virus antibody or (2) Hepatitis B surface antigen (HBsAg) with or without positive Hepatitis B core total antibody\n* Participants with a corrected QT interval (Bazett's; QTcB)\\>450 milliseconds (msec) (male) or \\>470 msec (female) at screening\n* Participants who have a history of inadequate clinical response to antipsychotic treatment for schizophrenia\n* Participants who have received treatment with any depot formulation of an antipsychotic medication within 1 dosing interval, minimum of 4 weeks, prior to screening\n* Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational product or unapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study\n* Have any other psychiatric diagnoses in addition to schizophrenia\n* Have previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity\n* Participants who have received an adequate treatment trial, in the opinion of the investigator, with clozapine at doses greater than 200 milligrams (mg) daily within 12 months prior to screening, or who have received any clozapine at all during the month before screening\n* Diagnosis of substance-induced psychosis within 7 days of screening (or at any time during the study)"}, 'identificationModule': {'nctId': 'NCT01328093', 'briefTitle': 'A Comparison Study of LY2140023 and Aripiprazole in Schizophrenia Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Denovo Biopharma LLC'}, 'officialTitle': 'A Phase 3, Multicenter, Double-Blind Comparison of LY2140023 and Aripiprazole in Patients With DSM-IV-TR Schizophrenia Followed by Open-Label Treatment With LY2140023', 'orgStudyIdInfo': {'id': '14211'}, 'secondaryIdInfos': [{'id': 'H8Y-MC-HBDE', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY2140023', 'description': 'Double Blind Phase: 40 milligrams (mg) administered orally, given twice daily for 24 weeks. Dose may be adjusted to a minimum of 20 mg or a maximum of 80 mg. Open Label Phase: 40 mg administered orally, given twice daily for an additional 28 weeks.', 'interventionNames': ['Drug: LY2140023']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aripiprazole', 'description': 'Double Blind Phase: 15 mg administered orally, given once daily for 24 weeks. Dose can be adjusted to a minimum of 10 mg or a maximum of 30 mg. Open Label Phase: LY2140023, 40 mg administered orally, given twice daily for an additional 28 weeks.', 'interventionNames': ['Drug: LY2140023', 'Drug: Aripiprazole']}], 'interventions': [{'name': 'LY2140023', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Aripiprazole', 'LY2140023']}, {'name': 'Aripiprazole', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Aripiprazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90703', 'city': 'Cerritos', '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': 33.85835, 'lon': -118.06479}}, {'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': '92845', 'city': 'Garden Grove', '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': 33.77391, 'lon': -117.94145}}, {'zip': '90813', 'city': 'Long Beach', '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': 33.76696, 'lon': -118.18923}}, {'zip': '94612', 'city': 'Oakland', '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': 37.80437, 'lon': -122.2708}}, {'zip': '91403', 'city': 'Sherman Oaks', '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': 34.15112, 'lon': -118.44925}}, {'zip': '33145', 'city': 'Coral Gables', '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': 25.72149, 'lon': -80.26838}}, {'zip': '32751', 'city': 'Maitland', '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': 28.62778, 'lon': -81.36312}}, {'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': '32771', 'city': 'Sanford', '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': 28.80055, 'lon': -81.27312}}, {'zip': '60640', 'city': 'Chicago', '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': 41.85003, 'lon': -87.65005}}, {'zip': '46260', 'city': 'Indianapolis', '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': 39.76838, 'lon': -86.15804}}, {'zip': '63141', 'city': 'Creve Coeur', 'state': 'Missouri', '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': 38.66089, 'lon': -90.42262}}, {'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', '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': 40.34872, 'lon': -74.65905}}, {'zip': '08046', 'city': 'Willingboro', 'state': 'New Jersey', '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': 40.02789, 'lon': -74.86905}}, {'zip': '11235', 'city': 'Brooklyn', 'state': 'New York', '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': 40.6501, 'lon': -73.94958}}, {'zip': '11516', 'city': 'Cedarhurst', 'state': 'New York', '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': 40.62288, 'lon': -73.7243}}, {'zip': '11366', 'city': 'Fresh Meadows', 'state': 'New York', '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': 40.73482, 'lon': -73.79347}}, {'zip': '14615', 'city': 'Rochester', 'state': 'New York', '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': 43.15478, 'lon': -77.61556}}, {'zip': '10312', 'city': 'Staten Island', 'state': 'New York', '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': 40.56233, 'lon': -74.13986}}, {'zip': '28211', 'city': 'Charlotte', 'state': 'North 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': 35.22709, 'lon': -80.84313}}, {'zip': '44122', 'city': 'Beachwood', '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': 41.4645, 'lon': -81.50873}}, {'zip': '44718', 'city': 'Canton', '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': 40.79895, 'lon': -81.37845}}, {'zip': '73103', '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': '97401', 'city': 'Eugene', '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': 44.05207, 'lon': -123.08675}}, {'zip': '18104', 'city': 'Allentown', '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': 40.60843, 'lon': -75.49018}}, {'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': '78754', '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': '75115', 'city': 'DeSoto', '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': 32.58986, 'lon': -96.85695}}, {'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': '1010', 'city': 'Vienna', 'country': 'Austria', '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': 48.20849, 'lon': 16.37208}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', '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': 50.63373, 'lon': 5.56749}}, {'zip': '1340', 'city': 'Ottignies', 'country': 'Belgium', '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': 50.66535, 'lon': 4.56679}}, {'zip': '59500', 'city': 'Douai', 'country': 'France', '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': 50.37069, 'lon': 3.07922}}, {'zip': '87025', 'city': 'Limoges', 'country': 'France', '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': 45.83362, 'lon': 1.24759}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', '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': 43.83665, 'lon': 4.35788}}, {'zip': '83506', 'city': 'Toulon', 'country': 'France', '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': 43.12442, 'lon': 5.92836}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', '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': 51.05089, 'lon': 13.73832}}, {'zip': '16515', 'city': 'Oranienburg', 'country': 'Germany', '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': 52.75577, 'lon': 13.24197}}, {'zip': '15-879', 'city': 'Bialystok', 'country': 'Poland', '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': 53.13333, 'lon': 23.16433}}, {'zip': '81-361', 'city': 'Gdynia', 'country': 'Poland', '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': 54.51889, 'lon': 18.53188}}, {'zip': '00926', 'city': 'San Juan', 'country': 'Puerto Rico', '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': 18.46633, 'lon': -66.10572}}, {'zip': '041914', 'city': 'Bucharest', 'country': 'Romania', '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': 44.43225, 'lon': 26.10626}}, {'zip': '540139', 'city': 'Târgu Mureş', 'country': 'Romania', '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': 46.54245, 'lon': 24.55747}}, {'zip': '28031', 'city': 'Madrid', 'country': 'Spain', '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': 40.4165, 'lon': -3.70256}}, {'zip': '41700', 'city': 'Seville', 'country': 'Spain', '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': 37.38283, 'lon': -5.97317}}, {'zip': '08500', 'city': 'Vic', 'country': 'Spain', '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': 41.93012, 'lon': 2.25486}}, {'zip': 'SE 972 35', 'city': 'Luleå', 'country': 'Sweden', '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': 65.58415, 'lon': 22.15465}}, {'zip': '21153', 'city': 'Malmo', 'country': 'Sweden', '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': 55.60587, 'lon': 13.00073}}], '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': 'Denovo Biopharma LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}