Viewing Study NCT01287520

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Ignite Creation Date: 2025-12-25 @ 4:24 AM
Ignite Modification Date: 2026-03-30 @ 7:35 AM
Study NCT ID: NCT01287520
Status: COMPLETED
Last Update Posted: 2019-02-25
First Post: 2011-01-28
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study of LY2090314 in Patients With Advanced or Metastatic Cancer
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C584053', 'term': '3-(9-fluoro-2-(piperidin-1-ylcarbonyl)-1,2,3,4-tetrahydro(1,4)diazepino(6,7,1-hi)indol-7-yl)-4-imidazo(1,2-a)pyridin-3-yl-1H-pyrrole-2,5-dione'}, {'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D011899', 'term': 'Ranitidine'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005663', 'term': 'Furans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'LY 10/Carb 5/Pem 500 (Cohort 1)', 'description': '* Cycle 1 Day 1 of 28 day cycle: 10 mg LY2090314 administered by intravenous infusion.\n* Cycle 1 Day 8 of 28 day cycle: 500 mg/m\\^2 Pem administered by intravenous infusion followed by AUC 5 mg/mL \\* min Carb administered by intravenous infusion.\n* Cycle 2 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m\\^2 Pem administered by intravenous infusion followed by AUC 5 mg/mL \\* min Carb administered by intravenous infusion followed by 10 mg LY2090314 administered by intravenous infusion.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'LY 10/Carb 6/Pem 500 (Cohort 2)', 'description': '* Cycle 1 Day 1 of 28 day cycle: 10 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28 day cycle: 500 mg/m\\^2 by Pem intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion.\n* Cycle 2 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'LY 20/Carb 6/Pem 500 (Cohort 3)', 'description': '* Cycle 1 Day 1 of 28 day cycle: 20 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28 day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion.\n* Cycle 2 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 20 mg LY2090314 by intravenous infusion.', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'LY 40/Carb 6/Pem 500 (Cohort 4)', 'description': '* Cycle 1 Day 1 of 28 day cycle: 40 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28 day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21 day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem by intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'LY 80/Carb 6/Pem 500 (Cohort 5)', 'description': '* Cycle 1 Day 1 of 28 day cycle: 80 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28 day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21 day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem by intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'LY 120/Carb 6/Pem 500 (Cohort 6)', 'description': '* Cycle 1 Day 1 of 28 day cycle: 120 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28 day cycle: 500 mg/m\\^Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21 day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem by intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.', 'otherNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'LY 80/Carb 6/Pem 500 + R50 (Cohort 7)', 'description': '* Cycle 1 Day 1 of 28 day cycle: pretreated with 50 mg ranitidine intravenous, 80 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28 day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6mg/mL \\* min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21 day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 intravenous infusion.\n\nBased on I2H-MV-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'LY 60/Carb 6/Pem 500 + R50 (Cohort 8)', 'description': '* Cycle 1 Day 1 of 28 day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28 day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6mg/mL \\* min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21 day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 intravenous infusion.\n\nBased on I2H-MV-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'LY 40/Carb 6/Pem 500 + R50 (Cohort 9)', 'description': '* Cycle 1 Day 1 of 28 day cycle: pretreated with 50 mg ranitidine intravenous, 40 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28 day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6mg/mL \\* min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40mmg LY2090314 40 mg by intravenous infusion.\n* Cycle 2 Day 1 of 21 day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 intravenous infusion.\n\nBased on I2H-MV-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 14, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 17, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 9, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Cardiac flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Asthenopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Pseudomembranous colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Recommended LY2090314 Dose for Phase 2 Studies (Maximum Tolerated Dose [MTD])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2090314/Pemetrexed/Carboplatin', 'description': 'Cycle 1 (28 days)\n\nCohorts 1 to 3\n\n* Cycle 1 Day 1: 10-20 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 5 or 6 mg/mL \\* min Carb by intravenous infusion.\n\nCohorts 4 to 9, Cohorts 7 to 9 were pretreated with 50 mg ranitidine intravenous-Cycle 1 Day 1: 40-120 mg LY2090314 by intravenous infusion.\n\n-Cycle 1 Day 8: 500 mg/m\\^2 by Pem intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 40-120 mg LY2090314 by intravenous infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Day 28 (Cycle 1)', 'description': "Recommended Phase 2 MTD was determined, when a dose limiting toxicity (DLT) occurred in 1 of 3 participants, the cohort was to be expanded to 6 participants. If a DLT occurred in 2 or more participants, accrual to the cohort was stopped, as the MTD was exceeded. A DLT was defined as an adverse event (AE) occurring in Cycle 1 (28 days) that was possibly related to study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0, ≥Grade 3 nonhematologic toxicity (except for nausea/vomiting without maximal symptomatic/prophylactic treatment) possibly or likely related to the study medication;CTCAE Grade 4 hematological toxicity of \\>5 days duration; Febrile neutropenia; CTCAE Grade 4 thrombocytopenia; CTCAE ≥Grade 2 thrombocytopenia plus bleeding; CTCAE ≥Grade 3 prolonged QTc interval.", 'unitOfMeasure': 'milligrams (mg)', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who have received at least 1 dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of LY2090314', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'LY 10/Carb 5 or Carb 6/Pem 500 (Cohorts 1 and 2)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 5 (Cohort 1) or AUC 6 (Cohort 2) mg/mL \\* min Carb by intravenous infusion.\n* Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 5 (Cohort 1) or AUC 6 (Cohort 2) mg/mL \\* min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.'}, {'id': 'OG001', 'title': 'LY 20/Carb 6/Pem 500 (Cohort 3)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 20 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion.\n* Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 20 mg LY2090314 by intravenous infusion.'}, {'id': 'OG002', 'title': 'LY 40/Carb 6/Pem 500 (Cohorts 4 and 9)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 40 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion-followed by 500 mg/m\\^2 Pem by intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 49 mg LY2090314 by intravenous infusion.\n\nCohort 9, LY2090314 pretreated with 50 mg ranitidine intravenous.\n\nBased on I2H-MV-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}, {'id': 'OG003', 'title': 'LY 80/Carb 6/Pem 500 (Cohorts 5 and 7)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 80 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem by intravenous infusion.\n* Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.\n\nCohort 7, LY2090314 pretreated with 50 mg ranitidine intravenous.\n\nBased on I2H-MV-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}, {'id': 'OG004', 'title': 'LY 120/Carb 6/Pem 500 (Cohort 6)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 120 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 by Pem intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.'}, {'id': 'OG005', 'title': 'LY 60/Carb 6/Pem 500 + R50 (Cohort 8)', 'description': '* Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6mg/mL \\* min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by pretreatment with 50 mg ranitidine intravenous and 60 mg LY2090314 intravenous infusion.\n\nBased on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}], 'classes': [{'categories': [{'measurements': [{'value': '216', 'spread': '26.3', 'groupId': 'OG000'}, {'value': '427', 'spread': '21.8', 'groupId': 'OG001'}, {'value': '976', 'spread': '42.6', 'groupId': 'OG002'}, {'value': '1870', 'spread': '76.7', 'groupId': 'OG003'}, {'value': '3310', 'spread': '18.7', 'groupId': 'OG004'}, {'value': '1600', 'spread': '47.3', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 of a 28 day cycle', 'description': 'AUC0-∞ was calculated from the area under the concentration versus time curve from time 0 to infinity of LY2090314 when administered alone.', 'unitOfMeasure': 'nanograms*hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of LY2090314 and had evaluable AUC0-∞ data, excluding 2 participants (1 in dose groups LY80 and 1 in dose group LY120) who received the wrong dose of LY2090314.'}, {'type': 'SECONDARY', 'title': 'PK Parameter: AUC0-∞ of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'LY 10/Carb 5 or Carb 6/Pem 500 (Cohorts 1 and 2)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 5 (Cohort 1) or AUC 6 (Cohort 2) mg/mL \\* min Carb by intravenous infusion.\n* Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 5 (Cohort 1) or AUC 6 (Cohort 2) mg/mL \\* min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.'}, {'id': 'OG001', 'title': 'LY 20/Carb 6/Pem 500 (Cohort 3)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 20 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion.\n* Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 20 mg LY2090314 by intravenous infusion.'}, {'id': 'OG002', 'title': 'LY 40/Carb 6/Pem 500 (Cohorts 4 and 9)', 'description': 'Cycle 1 Day 1 of 28-day cycle: 40 mg LY2090314 by intravenous infusion.\n\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem by intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.\n\nCohort 9, LY2090314 pretreated with 50 mg ranitidine intravenous.\n\nBased on I2H-MC-JWYa Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}, {'id': 'OG003', 'title': 'LY 80/Carb 6/Pem 500 (Cohorts 5 and 7)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 80 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem by intravenous infusion.\n* Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.\n\nCohort 7, LY2090314 pretreated with 50 mg ranitidine intravenous.\n\nBased on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}, {'id': 'OG004', 'title': 'LY 120/Carb 6/Pem 500 (Cohort 6)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 120 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 by Pem intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.'}, {'id': 'OG005', 'title': 'LY 60/Carb 6/Pem 500 + R50 (Cohort 8)', 'description': '* Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6mg/mL \\* min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by pretreatment with 50 mg ranitidine intravenous and 60 mg LY2090314 intravenous infusion.\n\nBased on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}], 'classes': [{'categories': [{'measurements': [{'value': '192', 'spread': '48.2', 'groupId': 'OG000'}, {'value': '404', 'spread': '33.2', 'groupId': 'OG001'}, {'value': '938', 'spread': '33.5', 'groupId': 'OG002'}, {'value': '1830', 'spread': '7.84', 'groupId': 'OG003'}, {'value': '2190', 'spread': 'NA', 'comment': '1 participant analyzed, therefore, unable to calculate geometric coefficient of variation.', 'groupId': 'OG004'}, {'value': '1570', 'spread': '36.5', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 8 of a 28-day cycle or Cycle 2 Day 1 of a 21-day cycle', 'description': 'AUC0-∞ was calculated from the area under the concentration versus time curves of LY2090314 from time zero to infinity when coadministered with Pem and Carb.', 'unitOfMeasure': 'nanograms*hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose LY2090314 coadministered with Pem and Carb and had enough samples to allow estimation of AUC0-∞ parameters excluding 2 participants (1 in dose groups LY80 and 1 in dose group LY120) who received the incorrect dose of LY2090314.'}, {'type': 'SECONDARY', 'title': 'PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'LY 10/Carb 5 or Carb 6/Pem 500 (Cohorts 1 and 2)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 5 (Cohort 1) or AUC 6 (Cohort 2) mg/mL \\* min Carb by intravenous infusion.\n* Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 5 (Cohort 1) or AUC 6 (Cohort 2) mg/mL \\* min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.'}, {'id': 'OG001', 'title': 'LY 20/Carb 6/Pem 500 (Cohort 3)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 20 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion.\n* Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by LY2090314 20 mg by intravenous infusion.'}, {'id': 'OG002', 'title': 'LY 40/Carb 6/Pem 500 (Cohorts 4 and 9 )', 'description': 'Cycle 1 Day 1 of 28-day cycle: 40 mg LY2090314 by intravenous infusion.\n\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem by intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 49 mg LY2090314 by intravenous infusion.\n\nCohort 9, LY2090314 pretreated with 50 mg ranitidine IV. Based on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}, {'id': 'OG003', 'title': 'LY 80/Carb 6/Pem 500 (Cohorts 5 and 7', 'description': '* Cycle 1 Day 1 of 28-day cycle: 80 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem by intravenous infusion.\n* Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.\n\nCohort 7, LY2090314 pretreated with 50 mg ranitidine IV.\n\nBased on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}, {'id': 'OG004', 'title': 'LY 120/Carb 6/Pem 500 (Cohort 6)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 120 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 by Pem intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.'}, {'id': 'OG005', 'title': 'LY 60/Carb 6/Pem 500 + R50 (Cohort 8)', 'description': '* Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by IV infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6mg/mL \\* min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by pretreatment with 50 mg ranitidine intravenous and 60 mg LY2090314 intravenous infusion.\n\nBased on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}], 'classes': [{'categories': [{'measurements': [{'value': '122', 'spread': '21.5', 'groupId': 'OG000'}, {'value': '246', 'spread': '29.0', 'groupId': 'OG001'}, {'value': '603', 'spread': '47.7', 'groupId': 'OG002'}, {'value': '898', 'spread': '50.5', 'groupId': 'OG003'}, {'value': '1700', 'spread': '63.2', 'groupId': 'OG004'}, {'value': '881', 'spread': '53.3', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 of a 28-day cycle', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of LY2090314 and had evaluable AUC0-∞ data, excluding 2 participants (1 in dose groups LY80 and 1 in dose group LY120) who received the incorrect dose of LY2090314.'}, {'type': 'SECONDARY', 'title': 'PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'LY 10/Carb 5 or Carb 6/Pem 500 (Cohorts 1 and 2)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 5 (Cohort 1) or AUC 6 (Cohort 2) mg/mL \\* min Carb by intravenous infusion.\n* Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 5 (Cohort 1) or AUC 6 (Cohort 2) mg/mL \\* min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.'}, {'id': 'OG001', 'title': 'LY 20/Carb 6/Pem 500 (Cohort 3)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 20 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion.\n* Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 20 mg LY2090314 by intravenous infusion.'}, {'id': 'OG002', 'title': 'LY 40/Carb 6/Pem 500 (Cohorts 4 and 9)', 'description': 'Cycle 1 Day 1 of 28-day cycle: 40 mg LY2090314 by intravenous infusion.\n\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem by intravenous infusion.\n* Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.\n\nCohort 9, LY2090314 pretreated with 50 mg ranitidine intravenous.\n\nBased on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}, {'id': 'OG003', 'title': 'LY 80/Carb 6/Pem 500 (Cohorts 5 and 7)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 80 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem by intravenous infusion.\n* Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.\n\nCohort 7, LY2090314 pretreated with 50 mg ranitidine IV.\n\nBased on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}, {'id': 'OG004', 'title': 'LY 120/Carb 6/Pem 500 (Cohort 6)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 120 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 by Pem intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.'}, {'id': 'OG005', 'title': 'LY 60/Carb 6/Pem 500 + R50 (Cohort 8)', 'description': '* Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6mg/mL \\* min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by pretreatment with 50 mg ranitidine intravenous and 60 mg LY2090314 intravenous infusion.\n\nBased on I2H-MC\\_JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}], 'classes': [{'categories': [{'measurements': [{'value': '106', 'spread': '57.5', 'groupId': 'OG000'}, {'value': '271', 'spread': '62.5', 'groupId': 'OG001'}, {'value': '657', 'spread': '44.1', 'groupId': 'OG002'}, {'value': '1150', 'spread': '27.8', 'groupId': 'OG003'}, {'value': '768', 'spread': 'NA', 'comment': '1 participant analyzed, therefore, unable to calculate geometric coefficient of variation.', 'groupId': 'OG004'}, {'value': '1040', 'spread': '48.2', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 8 of a 28-day cycle or Cycle 2 Day 1 of a 21-day cycle', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of LY2090314 and had evaluable AUC0-∞ data, excluding 2 participants (1 in dose groups LY80 and 1 in dose group LY120) who received the incorrect dose of LY2090314.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Best Overall Tumor Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'LY 10/Carb 5/Pem 500 (Cohort 1)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 5 mg/mL \\* min Carb by intravenous infusion.\n* Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 5 mg/mL \\* min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.'}, {'id': 'OG001', 'title': 'LY 10/Carb 6/Pem 500 (Cohort 2)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion.\n* Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.'}, {'id': 'OG002', 'title': 'LY 20/Carb 6/Pem 500 (Cohort 3)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 20 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion.\n* Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 20 mg LY2090314 by intravenous infusion.'}, {'id': 'OG003', 'title': 'LY 40/Carb 6/Pem 500 (Cohort 4)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 40 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem by intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.'}, {'id': 'OG004', 'title': 'LY 80/Carb 6/Pem 500 (Cohort 5)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 80 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem by intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.'}, {'id': 'OG005', 'title': 'LY 120/Carb 6/Pem 500 (Cohort 6)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 120 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem by intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.'}, {'id': 'OG006', 'title': 'LY 80/Carb 6/Pem 500 + R50 (Cohort 7)', 'description': '* Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 80 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6mg/mL \\* min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem intravenous infusion.\n* Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 IV infusion.\n\nBased on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}, {'id': 'OG007', 'title': 'LY 60/Carb 6/Pem 500 + R50 (Cohort 8)', 'description': '* Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6mg/mL \\* min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 intravenous infusion.\n\nBased on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}, {'id': 'OG008', 'title': 'LY 40/Carb 6/Pem 500 + R50 (Cohort 9)', 'description': '* Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 40 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6mg/mL \\* min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 intravenous Pem infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min by Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 intravenous infusion.\n\nBased on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'SD', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}]}, {'title': 'PD', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}]}, {'title': 'Unknown (discontinued before response assessment)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Cycle 9 (Cycle 1 was 28 days, Cycles 2 to 9 were 21 days)', 'description': 'Best overall observed tumor response at any point during the study until disease progression/recurrence defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as at least 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population: all participants who received at least 1 dose of study drug and had tumor response assessment.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of Pemetrexed (Pem)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemetrexed (Doublet Therapy)', 'description': 'Pem with Carb\n\n* Participants in Cohorts 1, 2 and 3 were administered 500 mg/m\\^2 Pem and AUC 5 or AUC 6 mg/mL \\* min Carb on Cycle 1, Day 8 of 28-day cycle by intravenous infusion.\n* Participants in Cohorts 4 through 9 were administered 500 mg/m\\^2 Pem and AUC 6 mg/mL \\* min Carb by intravenous infusion on Cycle 2 Day 1 of 21-day cycle'}, {'id': 'OG001', 'title': 'Pemetrexed (Triplet Therapy)', 'description': 'Pem with Carb and LY2090314\n\n* Participants in Cohorts 1, 2 and 3 were administered 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 5 or AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 10 mg up to 20 mg LY2090314 by intravenous infusion on Cycle 2 up to Cycle 10: Day 1 of 21-day cycle.\n* Participants in Cohorts 4 through 9 were administered 500 mg/m\\^2 Pem and AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 40 mg up to 120 mg of LY2090314 by intravenous infusion on Cycle 1, Day 8 of 28-day cycle and Cycle 3 up to Cycle 10: Day 1 of 21-day cycle.\n\nBased on I2H-MC-JWYA Protocol Amendment (D) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain to participants in Cohorts 7, 8 and 9.'}], 'classes': [{'categories': [{'measurements': [{'value': '212', 'spread': '34.4', 'groupId': 'OG000'}, {'value': '202', 'spread': '37.5', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 10 Day 1 of 21-day cycle', 'description': 'AUC0-∞ was calculated from the area under the concentration versus time curves of Pem given as a single dose with Carb (doublet therapy) and when co-administered with Carb and LY2090314 (triplet therapy).', 'unitOfMeasure': 'hours*nanograms/milliliter/ milligram', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were treated with Pem and Carb (doublet therapy) or who were treated with Pem, Carb and LY2090314 (triplet therapy) and had evaluable AUC0-∞ Pem data.'}, {'type': 'SECONDARY', 'title': 'PK Parameter: Maximum Plasma Concentration (Cmax) of Pemetrexed (Pem)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemetrexed (Doublet Therapy)', 'description': 'Pem with Carb\n\n* Participants in Cohorts 1, 2 and 3 were administered 500 mg/m\\^2 Pem and AUC 5 or AUC 6 mg/mL \\* min Carb on Cycle 1, Day 8 of 28-day cycle by intravenous infusion.\n* Participants in Cohorts 4 through 9 were administered 500 mg/m\\^2 Pem and AUC 6 mg/mL \\* min Carb by intravenous infusion on Cycle 2 Day 1 of 21-day cycle'}, {'id': 'OG001', 'title': 'Pemetrexed (Triplet Therapy)', 'description': 'Pem with Carb and LY2090317\n\n* Participants in Cohorts 1, 2 and 3 were administered 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 5 or AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 10 mg up to 20 mg LY2090314 by intravenous infusion on Cycle 2 up to Cycle 10: Day 1 of 21-day cycle.\n* Participants in Cohorts 4 through 9 were administered 500 mg/m\\^2 Pem and AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 40 mg up to 120 mg of LY2090314 by intravenous infusion on Cycle 1, Day 8 of 28-day cycle and Cycle 3 up to Cycle 10: Day 1 of 21-day cycle.\n\nBased on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain to participants in Cohorts 7, 8 and 9.'}], 'classes': [{'categories': [{'measurements': [{'value': '109', 'spread': '38.0', 'groupId': 'OG000'}, {'value': '108', 'spread': '43.1', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 10 Day 1 of 21-day cycle', 'description': 'Cmax of Pem given as a single dose with Carb (doublet therapy) and when coadministered with Carb and LY2090314 (triplet therapy).', 'unitOfMeasure': 'nanogram per milliliter per milligram', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were treated with Pem and Carb (doublet therapy) or who were treated with Pem, Carb and LY2090314 (triplet therapy) and had evaluable Cmax Pem data.'}, {'type': 'SECONDARY', 'title': 'PK Parameter: AUC0-∞ of Free Carboplatin (Carb)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carboplatin (Doublet Therapy)', 'description': 'Carb and Pem\n\n* Participants in Cohorts 1, 2 and 3 were administered 500 mg/m\\^2 Pem and AUC 5 or AUC 6 mg/mL \\* min Carb on Cycle 1, Day 8 of 28-day cycle by intravenous infusion.\n* Participants in Cohorts 4 through 9 were administered 500 mg/m\\^2 Pem and AUC 6 mg/mL \\* min Carb by intravenous infusion on Cycle 2 Day 1 of 21-day cycle'}, {'id': 'OG001', 'title': 'Carboplatin (Triplet Therapy)', 'description': 'Carb with Pem and LY2090314\n\n* Participants in Cohorts 1, 2 and 3 were administered 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 5 or AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 10 mg up to 20 mg LY2090314 by intravenous infusion on Cycle 2 up to Cycle 9: Day 1 of 21-day cycle.\n* Participants in Cohorts 4 through 9 were administered 500 mg/m\\^2 Pem and AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 40 mg up to 120 mg of LY2090314 by intravenous infusion on Cycle 1, Day 8 of 28-day cycle and Cycle 3 up to Cycle 9: Day 1 of 21-day cycle.\n\nBased on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain to participants in Cohorts 7, 8 and 9.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.6', 'spread': '41.8', 'groupId': 'OG000'}, {'value': '88.1', 'spread': '49.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycle', 'description': 'AUC0-∞ of free Carb was calculated from the area under the concentration versus time curves of Carb given as a single dose with Pem (doublet therapy) and when co-administered with Pem and LY2090314 (triplet therapy).', 'unitOfMeasure': 'hours*nanograms per milliliter per mg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were treated with Pem and Carb (doublet therapy) or Pem, Carb and LY2090314 (triplet therapy) and who had evaluable Carb AUC0-∞ data.'}, {'type': 'SECONDARY', 'title': 'PK Parameter: Cmax of Free Carboplatin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carboplatin (Doublet Therapy)', 'description': 'Carb and Pem\n\n* Participants in Cohorts 1, 2 and 3 were administered 500 mg/m\\^2 Pem and AUC 5 or AUC 6 mg/mL \\* min Carb on Cycle 1, Day 8 of 28-day cycle by intravenous infusion.\n* Participants in Cohorts 4 through 9 were administered 500 mg/m\\^2 Pem and AUC 6 mg/mL \\* min Carb by intravenous infusion on Cycle 2 Day 1 of 21-day cycle'}, {'id': 'OG001', 'title': 'Carboplatin (Triplet Therapy)', 'description': 'Carb and Pem with LY2090314\n\n* Participants in Cohorts 1, 2 and 3 were administered 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 5 or AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 10 mg up to 20 mg LY2090314 by intravenous infusion on Cycle 2 up to Cycle 9: Day 1 of 21-day cycle.\n* Participants in Cohorts 4 through 9 were administered 500 mg/m\\^2 Pem and AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 40 mg up to 120 mg of LY2090314 by intravenous infusion on Cycle 1, Day 8 of 28-day cycle and Cycle 3 up to Cycle 10: Day 1 of 21-day cycle.\n\nBased on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain to participants in Cohorts 7, 8 and 9.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'spread': '43.9', 'groupId': 'OG000'}, {'value': '25.5', 'spread': '46.0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1, Day 8 of 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycle', 'description': 'Cmax of free Carb given as a single dose with Pem (doublet therapy) and when co-administered with Pem and LY2090314 (triplet therapy).', 'unitOfMeasure': 'nanograms/milliliter/milligram', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were treated with Pem and Carb (doublet therapy) or who were treated with Pem, Carb and LY2090314 (triplet therapy) and had evaluable Carb Cmax data.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamic (PD) Changes in Beta-Catenin (β-catenin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'LY 10/Carb 5/Pem 500 (Cohort 1)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 5 mg/mL \\* min Carb by IV infusion.\n* Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 5 mg/mL \\* min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.'}, {'id': 'OG001', 'title': 'LY 10/Carb 6/Pem 500 (Cohort 2)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by IV infusion.\n* Cycle 1 Day 8 of 28-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion.\n* Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.'}, {'id': 'OG002', 'title': 'LY 20/Carb 6/Pem 500 (Cohort 3)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 20 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28 -ay cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion.\n* Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 20 mg LY2090314 by intravenous infusion.'}, {'id': 'OG003', 'title': 'LY 40/Carb 6/Pem 500 (Cohort 4)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 40 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem by intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.'}, {'id': 'OG004', 'title': 'LY 80/Carb 6/Pem 500 (Cohort 5)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 80 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem by intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.'}, {'id': 'OG005', 'title': 'LY 120/Carb 6/Pem 500 (Cohort 6)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 120 mg LY2090314 mg by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem by intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.'}, {'id': 'OG006', 'title': 'LY 80/Carb 6/Pem 500 + R50 (Cohort 7)', 'description': '* Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 80 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem intravenous infusion.\n* Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 intravenous infusion.\n\nBased on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}, {'id': 'OG007', 'title': 'LY 60/Carb 6/Pem 500 + R50 (Cohort 8)', 'description': '* Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6mg/mL \\* min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 50 mg ranitidine IV pretreatment and 60 mg LY2090314 intravenous infusion.\n\nBased on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}, {'id': 'OG008', 'title': 'LY 40/Carb 6/Pem 500 + R50 (Cohort 9)', 'description': '* Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 40 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6mg/mL \\* min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 intravenous infusion.\n\nBased on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}], 'timeFrame': 'Baseline, Cycle 1 , Day 1 of a 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycles', 'description': 'PD change from baseline to endpoint (up to Cycle 9) in β-catenin levels in peripheral blood mononuclear cells (PBMCs) following the administration of LY2090314 given alone and in combination with Pem and Carb. This outcome measure was not analyzed due to insufficient data.', 'reportingStatus': 'POSTED', 'populationDescription': 'There was insufficient data from participants who received at least 1 dose of LY2090314 to perform β-catenin modeling, thus zero participants were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LY 10/Carb 5/Pem 500 (Cohort 1)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 10 milligrams (mg) LY2090314 (LY) administered by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle: 500 milligrams per meter squared (mg/m\\^2) pemetrexed (Pem) administered by intravenous infusion followed by Area Under the Time Curve (AUC) 5 milligrams per milliliter times minutes (mg/mL \\* min) carboplatin (Carb) administered by intravenous infusion.\n* Cycle 2 and beyond: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem administered by intravenous infusion followed by AUC 5 mg/mL \\* min Carb administered by intravenous infusion followed by 10 mg LY2090314 administered by intravenous infusion.'}, {'id': 'FG001', 'title': 'LY 10/Carb 6/Pem 500 (Cohort 2)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion.\n* Cycle 2 and beyond: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.'}, {'id': 'FG002', 'title': 'LY 20/Carb 6/Pem 500 (Cohort 3)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 20 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion.\n* Cycle 2 and beyond: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 20 mg LY2090314 by intravenous infusion.'}, {'id': 'FG003', 'title': 'LY 40/Carb 6/Pem 500 (Cohort 4)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 40 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem by intravenous infusion.\n* Cycle 3 and beyond: Day 1 of 21 day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.'}, {'id': 'FG004', 'title': 'LY 80/Carb 6/Pem 500 (Cohort 5)', 'description': '* Cycle 1 Day 1 of 28 -ay cycle: 80 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem by intravenous infusion.\n* Cycle 3 up and beyond: Day 1 of 21 day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion'}, {'id': 'FG005', 'title': 'LY 120/Carb 6/Pem 500 -(Cohort 6)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 120 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem by intravenous infusion.\n* Cycle 3 and beyond: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.'}, {'id': 'FG006', 'title': 'LY 80/Carb 6/Pem 500 + R50 (Cohort 7)', 'description': '* Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine (R50) intravenous, 80 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem IV infusion.\n* Cycle 3 and beyond: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 intravenous infusion.\n\nBased on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}, {'id': 'FG007', 'title': 'LY 60/Carb 6/Pem 500 + R50 (Cohort 8)', 'description': '* Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by IV infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6mg/mL \\* min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem intravenous infusion.\n* Cycle 3 and beyond: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 intravenous infusion.\n\nBased on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}, {'id': 'FG008', 'title': 'LY 40/Carb 6/Pem 500 + R50 (Cohort 9)', 'description': '* Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 40 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem intravenous infusion.\n* Cycle 3 and beyond: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 50 mg ranitidine IV pretreatment and 40 mg LY2090314 intravenous infusion.\n\nBased on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'comment': 'One participant who received study drug but did not complete Cycle 1 was replaced.', 'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'comment': 'One participant who received study drug but did not complete Cycle 1 was replaced.', 'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'The reasons for discontinuation listed in the participant flow are the reasons the participant discontinued treatment and a participant was considered to have "completed" the trial if they discontinued treatment due to progressive disease or an adverse event.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '41', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'LY 10/Carb 5/Pem 500 (Cohort 1)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 5 mg/mL \\* min Carb by intravenous infusion.\n* Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 5 mg/mL \\* min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.'}, {'id': 'BG001', 'title': 'LY 10/Carb 6/Pem 500 (Cohort 2)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 10 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion.\n* Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 10 mg LY2090314 by intravenous infusion.'}, {'id': 'BG002', 'title': 'LY 20/Carb 6/Pem 500 (Cohort 3)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 20 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion.\n* Cycle 2 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 20 mg LY2090314 by intravenous infusion.'}, {'id': 'BG003', 'title': 'LY 40/Carb 6/Pem 500 (Cohort 4)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 40 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem by intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 40 mg LY2090314 by intravenous infusion.'}, {'id': 'BG004', 'title': 'LY 80/Carb 6/Pem 500 (Cohort 5)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 80 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem by intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 80 mg LY2090314 by intravenous infusion.'}, {'id': 'BG005', 'title': 'LY 120/Carb 6/Pem 500 (Cohort 6)', 'description': '* Cycle 1 Day 1 of 28-day cycle: 120 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem by intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 120 mg LY2090314 by intravenous infusion.'}, {'id': 'BG006', 'title': 'LY 80/Carb 6/Pem 500 + R50 (Cohort 7)', 'description': '* Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 80 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6mg/mL \\* min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem intravenous infusion.\n* Cycle 3 up to Cycle 10: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 intravenous infusion.\n\nBased on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}, {'id': 'BG007', 'title': 'LY 60/Carb 6/Pem 500 + R50 (Cohort 8)', 'description': '* Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 60 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6mg/mL \\* min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 60 mg LY2090314 intravenous infusion.\n\nBased on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}, {'id': 'BG008', 'title': 'LY 40/Carb 6/Pem 500 + R50 (Cohort 9)', 'description': '* Cycle 1 Day 1 of 28-day cycle: pretreated with 50 mg ranitidine intravenous, 40 mg LY2090314 by intravenous infusion.\n* Cycle 1 Day 8 of 28-day cycle 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6mg/mL \\* min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 by intravenous infusion.\n* Cycle 2 Day 1 of 21-day cycle: AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 500 mg/m\\^2 Pem intravenous infusion.\n* Cycle 3 up to Cycle 9: Day 1 of 21-day cycle: 500 mg/m\\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \\* min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 40 mg LY2090314 intravenous infusion.\n\nBased on I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.81', 'spread': '11.88', 'groupId': 'BG000'}, {'value': '55.27', 'spread': '9.19', 'groupId': 'BG001'}, {'value': '59.31', 'spread': '5.62', 'groupId': 'BG002'}, {'value': '58.32', 'spread': '8.95', 'groupId': 'BG003'}, {'value': '57.35', 'spread': '7.59', 'groupId': 'BG004'}, {'value': '56.73', 'spread': '7.52', 'groupId': 'BG005'}, {'value': '55.39', 'spread': '9.86', 'groupId': 'BG006'}, {'value': '58.78', 'spread': '9.06', 'groupId': 'BG007'}, {'value': '61.35', 'spread': '4.41', 'groupId': 'BG008'}, {'value': '57.79', 'spread': '7.65', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '18', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '23', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '38', 'groupId': 'BG009'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '41', 'groupId': 'BG009'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Surface Area', 'classes': [{'categories': [{'measurements': [{'value': '1.76', 'spread': '0.11', 'groupId': 'BG000'}, {'value': '2.10', 'spread': '0.13', 'groupId': 'BG001'}, {'value': '1.66', 'spread': '0.14', 'groupId': 'BG002'}, {'value': '1.94', 'spread': '0.29', 'groupId': 'BG003'}, {'value': '1.77', 'spread': '0.46', 'groupId': 'BG004'}, {'value': '2.11', 'spread': '0.33', 'groupId': 'BG005'}, {'value': '2.07', 'spread': '0.14', 'groupId': 'BG006'}, {'value': '1.90', 'spread': '0.30', 'groupId': 'BG007'}, {'value': '2.04', 'spread': '0.15', 'groupId': 'BG008'}, {'value': '1.94', 'spread': '0.27', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'meters squared (m^2)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) performance', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '36', 'groupId': 'BG009'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}]}]}], 'paramType': 'NUMBER', 'description': 'ECOG - Classified participants according to their functional impairment. Scores ranged from 0 to 5: 0=Fully Active, No Restrictions; 1=Ambulatory, Able to Perform Light Work Activities (for example, light house work), Restricted Strenuous Activity; 2=Ambulatory, All Self Care, No Work Activities; 3=Partially Confined to Bed (\\>50% of waking hours), Limited Self Care; 4=Completely Disabled, Totally Bedridden; 5=Death', 'unitOfMeasure': 'participants'}, {'title': 'Basis of Diagnosis', 'classes': [{'title': 'Cytological', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}]}]}, {'title': 'Histopathological', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '33', 'groupId': 'BG009'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Initial Pathological Tumor Diagnosis', 'classes': [{'title': 'Mesothelioma', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '9', 'groupId': 'BG009'}]}]}, {'title': 'Non-small cell lung carcinoma (NSCLC)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}]}]}, {'title': 'Leimyosarcoma', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}]}]}, {'title': 'Esophagus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}]}]}, {'title': 'Lung adenocarcinoma', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}]}]}, {'title': 'Rectum', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}]}]}, {'title': 'Small cell lung carcinoma (SCLC)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}]}]}, {'title': 'Gastric', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}]}]}, {'title': 'Head and neck', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}]}, {'title': 'Adenocarcinoma not otherwise specified (NOS)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}]}, {'title': 'Colon', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}]}, {'title': 'Breast', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}]}, {'title': 'Pancreas', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}]}, {'title': 'Cancer NOS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}]}, {'title': 'Gall bladder', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}]}, {'title': 'Thymoma', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}]}, {'title': 'Adenoid', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}]}, {'title': 'Bile duct', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-17', 'studyFirstSubmitDate': '2011-01-28', 'resultsFirstSubmitDate': '2018-10-17', 'studyFirstSubmitQcDate': '2011-01-31', 'lastUpdatePostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-17', 'studyFirstPostDateStruct': {'date': '2011-02-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recommended LY2090314 Dose for Phase 2 Studies (Maximum Tolerated Dose [MTD])', 'timeFrame': 'Baseline up to Day 28 (Cycle 1)', 'description': "Recommended Phase 2 MTD was determined, when a dose limiting toxicity (DLT) occurred in 1 of 3 participants, the cohort was to be expanded to 6 participants. If a DLT occurred in 2 or more participants, accrual to the cohort was stopped, as the MTD was exceeded. A DLT was defined as an adverse event (AE) occurring in Cycle 1 (28 days) that was possibly related to study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0, ≥Grade 3 nonhematologic toxicity (except for nausea/vomiting without maximal symptomatic/prophylactic treatment) possibly or likely related to the study medication;CTCAE Grade 4 hematological toxicity of \\>5 days duration; Febrile neutropenia; CTCAE Grade 4 thrombocytopenia; CTCAE ≥Grade 2 thrombocytopenia plus bleeding; CTCAE ≥Grade 3 prolonged QTc interval."}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of LY2090314', 'timeFrame': 'Cycle 1 Day 1 of a 28 day cycle', 'description': 'AUC0-∞ was calculated from the area under the concentration versus time curve from time 0 to infinity of LY2090314 when administered alone.'}, {'measure': 'PK Parameter: AUC0-∞ of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb)', 'timeFrame': 'Cycle 1 Day 8 of a 28-day cycle or Cycle 2 Day 1 of a 21-day cycle', 'description': 'AUC0-∞ was calculated from the area under the concentration versus time curves of LY2090314 from time zero to infinity when coadministered with Pem and Carb.'}, {'measure': 'PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314', 'timeFrame': 'Cycle 1 Day 1 of a 28-day cycle'}, {'measure': 'PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb)', 'timeFrame': 'Cycle 1 Day 8 of a 28-day cycle or Cycle 2 Day 1 of a 21-day cycle'}, {'measure': 'Number of Participants With Best Overall Tumor Response', 'timeFrame': 'Baseline up to Cycle 9 (Cycle 1 was 28 days, Cycles 2 to 9 were 21 days)', 'description': 'Best overall observed tumor response at any point during the study until disease progression/recurrence defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as at least 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria.'}, {'measure': 'Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of Pemetrexed (Pem)', 'timeFrame': 'Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 10 Day 1 of 21-day cycle', 'description': 'AUC0-∞ was calculated from the area under the concentration versus time curves of Pem given as a single dose with Carb (doublet therapy) and when co-administered with Carb and LY2090314 (triplet therapy).'}, {'measure': 'PK Parameter: Maximum Plasma Concentration (Cmax) of Pemetrexed (Pem)', 'timeFrame': 'Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 10 Day 1 of 21-day cycle', 'description': 'Cmax of Pem given as a single dose with Carb (doublet therapy) and when coadministered with Carb and LY2090314 (triplet therapy).'}, {'measure': 'PK Parameter: AUC0-∞ of Free Carboplatin (Carb)', 'timeFrame': 'Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycle', 'description': 'AUC0-∞ of free Carb was calculated from the area under the concentration versus time curves of Carb given as a single dose with Pem (doublet therapy) and when co-administered with Pem and LY2090314 (triplet therapy).'}, {'measure': 'PK Parameter: Cmax of Free Carboplatin', 'timeFrame': 'Cycle 1, Day 8 of 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycle', 'description': 'Cmax of free Carb given as a single dose with Pem (doublet therapy) and when co-administered with Pem and LY2090314 (triplet therapy).'}, {'measure': 'Pharmacodynamic (PD) Changes in Beta-Catenin (β-catenin)', 'timeFrame': 'Baseline, Cycle 1 , Day 1 of a 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycles', 'description': 'PD change from baseline to endpoint (up to Cycle 9) in β-catenin levels in peripheral blood mononuclear cells (PBMCs) following the administration of LY2090314 given alone and in combination with Pem and Carb. This outcome measure was not analyzed due to insufficient data.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Advanced Cancer']}, 'referencesModule': {'references': [{'pmid': '26403509', 'type': 'DERIVED', 'citation': 'Gray JE, Infante JR, Brail LH, Simon GR, Cooksey JF, Jones SF, Farrington DL, Yeo A, Jackson KA, Chow KH, Zamek-Gliszczynski MJ, Burris HA 3rd. A first-in-human phase I dose-escalation, pharmacokinetic, and pharmacodynamic evaluation of intravenous LY2090314, a glycogen synthase kinase 3 inhibitor, administered in combination with pemetrexed and carboplatin. Invest New Drugs. 2015 Dec;33(6):1187-96. doi: 10.1007/s10637-015-0278-7. Epub 2015 Sep 25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine a recommended Phase 2 dose and dosing regimen of LY2090314 in combination with pemetrexed and carboplatin in patients with advanced/metastatic cancer. Part A of this study will consist of dose escalation of the study regimen, and Part B will consist of an expanded cohort to confirm the dose provided from Part A.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) scale\n* Have a life expectancy of greater than or equal to 12 weeks\n* Males and females with reproductive potential agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug\n* Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic disease for which no proven effective therapy exists\n* Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)\n* Have adequate hematologic, hepatic, and renal function\n* Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 30 days (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy.\n\nExclusion Criteria:\n\n* Have received treatment within 30 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication\n* Have serious preexisting medical conditions (left to discretion of investigator)\n* Have one of the following conduction abnormalities: Corrected time between start of Q wave and end of T wave (QTc) prolongation \\>450 millisecond (msec) on screening electrocardiogram (ECG), previous history of QTc prolongation with another medication that required discontinuation, congenital long-QT-syndrome, or left bundle branch block (LBBB)\n* Are taking any concomitant medication that may cause QTc prolongation, or induce Torsades de Pointes\n* Have systolic blood pressure greater than or equal to 140 millimeters of Mercury (mm Hg), and diastolic blood pressure greater than or equal to 90 mm Hg that is not controlled by medical therapy\n* Have serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class II or higher; have history of arrhythmia that is symptomatic or requires treatment\n* Have chronic atrial fibrillation and/or bradycardia\n* Have uncorrected electrolyte disorders including potassium \\<3.4 molar equivalent per liter (mEq/L) (\\<3.4 millimole per liter \\[mmol/l\\]), calcium \\<8.4 milligram per deciliter (mg/dL) (2.1 mmol/L), or magnesium \\<1.2 mg/dL (\\<0.62 mmol/L)\n* Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required)\n* Have a hematologic malignancy\n* Females who are pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT01287520', 'briefTitle': 'A Study of LY2090314 in Patients With Advanced or Metastatic Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Phase 1 Dose Escalation Study of LY2090314 in Patients With Advanced or Metastatic Cancer in Combination With Pemetrexed and Carboplatin', 'orgStudyIdInfo': {'id': '11613'}, 'secondaryIdInfos': [{'id': 'I2H-MC-JWYA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY2090314/pemetrexed/carboplatin', 'description': 'Part A, Cycle 1 (28 days): Intravenous doses of LY2090314 starting at 10 milligram (mg) were given on Day 1 followed by 10 mg LY2090314, 500 milligram per square meter (mg/m\\^2) pemetrexed (intravenous dose), and 5 or 6 area under the concentration-time curve (AUC) intravenous dose of carboplatin on Day 8.\n\nPart A, Cycle 2 (21 days): Pemetrexed and carboplatin given on Day 1 at the same dose administered in Cycle 1.\n\nPart A, Cycle 3 (21 days) and beyond: LY2090314, Pemetrexed and carboplatin were given on Day 1 at the same dose administered in Cycle 1. LY2090314 doses were escalated until the maximum tolerated dose (MTD) was reached.\n\nPart B: Dose determined in Part A was administered. Participants were allowed to continue the combination treatment if they were receiving therapeutic benefit until they fulfilled one of the criteria for discontinuation.', 'interventionNames': ['Drug: LY2090314', 'Drug: pemetrexed', 'Drug: Carboplatin', 'Other: ranitidine']}], 'interventions': [{'name': 'LY2090314', 'type': 'DRUG', 'description': 'Administered intravenously', 'armGroupLabels': ['LY2090314/pemetrexed/carboplatin']}, {'name': 'pemetrexed', 'type': 'DRUG', 'otherNames': ['Alimta', 'LY231514'], 'description': 'Administered intravenously', 'armGroupLabels': ['LY2090314/pemetrexed/carboplatin']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Administered intravenously', 'armGroupLabels': ['LY2090314/pemetrexed/carboplatin']}, {'name': 'ranitidine', 'type': 'OTHER', 'description': 'Per I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine given as pretreatment to LY2090314 for stomach pain.', 'armGroupLabels': ['LY2090314/pemetrexed/carboplatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}