Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT00267020
Status:
COMPLETED
Last Update Posted:
2020-08-31
First Post:
2005-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Phase 2 Study of Gemcitabine or Gemcitabine + Enzastaurin in Participants With Advanced or Metastatic Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C504878', 'term': 'enzastaurin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'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': {'timeFrame': 'Baseline through study completion (27.7 months)', 'description': 'Study-specific clinical outcomes due to progressive disease were not considered to be serious adverse events (SAEs) unless it was deemed related to study drug by the investigator.', 'eventGroups': [{'id': 'EG000', 'title': 'Enzastaurin+Gemcitabine', 'description': 'Enzastaurin: 1200 milligrams (mg) administered orally (as three 400-mg doses) after a meal on Day 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 2 to 28 in Cycle 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 1 to 28 in Cycle 2 and later.\n\nGemcitabine: 1000 milligrams/square meter (mg/m\\^2) administered intravenously on Days 1, 8 and 15 of each 28-day cycle.', 'otherNumAtRisk': 82, 'otherNumAffected': 80, 'seriousNumAtRisk': 82, 'seriousNumAffected': 49}, {'id': 'EG001', 'title': 'Gemcitabine', 'description': 'Gemcitabine: 1000 mg/m\\^2 administered intravenously on Days 1, 8 and 15 of each of each 28-day cycle.', 'otherNumAtRisk': 39, 'otherNumAffected': 38, 'seriousNumAtRisk': 39, 'seriousNumAffected': 23}], 'otherEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 50, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Vascular access complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 46, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Laboratory test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 46, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Speech disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Chromaturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Epistaxis', 'stats': 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'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Hydropneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Internal fixation of fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enzastaurin+Gemcitabine', 'description': 'Enzastaurin: 1200 milligrams (mg) administered orally (as three 400-mg doses) after a meal on Day 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 2 to 28 in Cycle 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 1 to 28 in Cycle 2 and later.\n\nGemcitabine: 1000 milligrams/square meter (mg/m\\^2) administered intravenously on Days 1, 8 and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Gemcitabine', 'description': 'Gemcitabine: 1000 mg/m\\^2 administered intravenously on Days 1, 8 and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '6.9'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '8.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to the date of death from any cause up to 27.7 months', 'description': 'OS was the duration from randomization to death. OS was censored at the last contact for participants who were alive, at the cut-off date.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to -treat (ITT) population: All randomized participants. Participants censored: Enzastaurin+Gemcitabine = 17; Gemcitabine = 11.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enzastaurin+Gemcitabine', 'description': 'Enzastaurin: 1200 milligrams (mg) administered orally (as three 400-mg doses) after a meal on Day 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 2 to 28 in Cycle 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 1 to 28 in Cycle 2 and later.\n\nGemcitabine: 1000 milligrams/square meter (mg/m\\^2) administered intravenously on Days 1, 8 and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Gemcitabine', 'description': 'Gemcitabine: 1000 mg/m\\^2 administered intravenously on Days 1, 8 and 15 of each 28-day cycle.'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '15.4'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '17.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to measured progressive disease (PD) up to 19.9 months', 'description': 'Response rate was defined as percentage of responders (best study response recorded as CR or PR) from the qualified number of participants for tumor response analysis. Response defined using Response Evaluation Criteria In Solid Tumors (RECIST, v1.0) criteria: CR was disappearance of all target lesions for at least 4 weeks. PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD.\n\nPercentage of participants was calculated as: (The number of responders with CR or PR/ The number of participants qualified for tumor response analysis) × 100.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population: Randomized participants who had: 1) histological or cytological diagnosis of locally advanced (Stage II, III) or metastatic (Stage IV) adenocarcinoma of the pancreas; 2) no concurrent systemic chemotherapy; 3) presence of measurable disease at baseline; and 4) received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enzastaurin+Gemcitabine', 'description': 'Enzastaurin: 1200 milligrams (mg) administered orally (as three 400-mg doses) after a meal on Day 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 2 to 28 in Cycle 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 1 to 28 in Cycle 2 and later.\n\nGemcitabine: 1000 milligrams/square meter (mg/m\\^2) administered intravenously on Days 1, 8 and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Gemcitabine', 'description': 'Gemcitabine: 1000 mg/m\\^2 administered intravenously on Days 1, 8 and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '4.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '4.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to measured PD or death from any cause up to 21.6 months', 'description': 'PFS was defined as the time from the date of randomization to the first date of documented progressive disease (PD) or death due to any cause, whichever occurred first. PFS was censored at the date of the last assessment visit for participants who were still alive at data cut-off and who had not had documented progressive disease. Participants who started a new treatment before progression were censored as of the date of the start of new treatment.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized participants. Participants censored: Enzastaurin+Gemcitabine = 21; Gemcitabine = 10.'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enzastaurin+Gemcitabine', 'description': 'Enzastaurin: 1200 milligrams (mg) administered orally (as three 400-mg doses) after a meal on Day 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 2 to 28 in Cycle 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 1 to 28 in Cycle 2 and later.\n\nGemcitabine: 1000 milligrams/square meter (mg/m\\^2) administered intravenously on Days 1, 8 and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Gemcitabine', 'description': 'Gemcitabine: 1000 mg/m\\^2 administered intravenously on Days 1, 8 and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '13.9'}, {'value': '9.2', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '12.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time of response to PD or death from any cause up to 19.9 months', 'description': 'The duration of a complete response (CR) or partial response (PR) was defined, using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria, as the time from first objective status assessment of CR or PR to the first time of disease progression or death as a result of any cause. Using the Response Evaluation Criteria in Solid Tumors (RECIST V1.0) criteria, CR was defined as the disappearance of all tumor lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD. Duration of response was censored at the date of the last assessment visit for responders who were still alive at data cut-off and had no documented progressive disease (PD).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Per Protocol population with a CR or PR: With histological or cytological diagnosis of locally advanced adenocarcinoma of the pancreas; no concurrent systemic chemotherapy; presence of measurable disease at baseline; and treatment with at least 1 dose of study drug. Censored: Enzastaurin+Gemcitabine = 1; Gemcitabine = 0.'}, {'type': 'SECONDARY', 'title': 'Change in Scores From Baseline (Improved, Stable or Worsened) to End of Study in Functional Assessment of Cancer Therapy Hepatobiliary Version 4 ( FACT-Hep v.4) (Quality of Life (QOL))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enzastaurin+Gemcitabine', 'description': 'Enzastaurin: 1200 milligrams (mg) administered orally (as three 400-mg doses) after a meal on Day 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 2 to 28 in Cycle 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 1 to 28 in Cycle 2 and later.\n\nGemcitabine: 1000 milligrams/square meter (mg/m\\^2) administered intravenously on Days 1, 8 and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Gemcitabine', 'description': 'Gemcitabine: 1000 mg/m\\^2 administered intravenously on Days 1, 8 and 15 of each 28-day cycle.'}], 'classes': [{'title': 'Physical well-being- Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '3.48', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '2.71', 'groupId': 'OG001'}]}]}, {'title': 'Physical well-being- Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.80', 'groupId': 'OG001'}]}]}, {'title': 'Physical well-being- Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.0', 'spread': '4.08', 'groupId': 'OG000'}, {'value': '-7.8', 'spread': '3.96', 'groupId': 'OG001'}]}]}, {'title': 'Social well-being- Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '2.10', 'groupId': 'OG001'}]}]}, {'title': 'Social well-being- Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.21', 'groupId': 'OG001'}]}]}, {'title': 'Social well-being- Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.5', 'spread': '3.80', 'groupId': 'OG000'}, {'value': '-5.5', 'spread': '2.66', 'groupId': 'OG001'}]}]}, {'title': 'Emotional well-being- Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '4.76', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '3.79', 'groupId': 'OG001'}]}]}, {'title': 'Emotional well-being- Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.36', 'groupId': 'OG001'}]}]}, {'title': 'Emotional well-being- Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.8', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '-8.2', 'spread': '4.15', 'groupId': 'OG001'}]}]}, {'title': 'Functional well-being- Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.8', 'spread': '3.63', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '1.73', 'groupId': 'OG001'}]}]}, {'title': 'Functional well-being- Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Functional well-being- Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.6', 'spread': '5.37', 'groupId': 'OG000'}, {'value': '-8.5', 'spread': '4.42', 'groupId': 'OG001'}]}]}, {'title': 'Hepatobiliary cancer subscale- Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.7', 'spread': '4.67', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '5.20', 'groupId': 'OG001'}]}]}, {'title': 'Hepatobiliary cancer subscale- Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '3.00', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '3.78', 'groupId': 'OG001'}]}]}, {'title': 'Hepatobiliary cancer subscale- Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.6', 'spread': '4.70', 'groupId': 'OG000'}, {'value': '-10.0', 'spread': '4.32', 'groupId': 'OG001'}]}]}, {'title': 'Total Outcome Index- Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.4', 'spread': '11.20', 'groupId': 'OG000'}, {'value': '19.0', 'spread': '11.49', 'groupId': 'OG001'}]}]}, {'title': 'Total outcome index- Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '5.40', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '4.76', 'groupId': 'OG001'}]}]}, {'title': 'Total outcome index- Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-35.9', 'spread': '13.03', 'groupId': 'OG000'}, {'value': '-23.0', 'spread': '9.88', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-Hep score- Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.0', 'spread': '16.81', 'groupId': 'OG000'}, {'value': '27.5', 'spread': '17.91', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-Hep score- Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '5.65', 'groupId': 'OG000'}, {'value': '0', 'spread': '4.19', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-Hep score- Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-37.9', 'spread': '13.71', 'groupId': 'OG000'}, {'value': '-26.6', 'spread': '12.26', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-G-score- Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.1', 'spread': '11.63', 'groupId': 'OG000'}, {'value': '24.1', 'spread': '18.95', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-G-score- Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '3.56', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '4.17', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-G-score- Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20.1', 'spread': '10.59', 'groupId': 'OG000'}, {'value': '-21.2', 'spread': '10.75', 'groupId': 'OG001'}]}]}, {'title': 'FACT Hep Symptoms Index- Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.4', 'spread': '3.95', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '2.50', 'groupId': 'OG001'}]}]}, {'title': 'FACT Hep Symptoms Index- Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.85', 'groupId': 'OG001'}]}]}, {'title': 'FACT Hep Symptoms Index- Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.0', 'spread': '3.31', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '2.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through end of study up to 27.7 months', 'description': 'FACT-Hep consists of 45 items in five subscales (1) physical well-being (PWB) score rage 0 -28; (2) social well-being (SWB) score range 0-28; (3) emotional well-being (EWB) score range 0-24; (4) functional well-being (FWB) score range 0-28; and (5) the hepatobiliary cancer subscale (HCS) Score range 0-72. The Trial Outcomes Index (TOI) is the sum of the PWB, FWB and Hep subscales with a scores range of 0 to 128. The Total FACT-Hep score was the sum of all questions with a scores range of 0 to 180. The Total FACT-G score was the sum of the 27 questions in the PWB, SFWB, EWB and FWB with a scores range of 0 to 108. The FACT-Hep Symptoms Index with 8 key questions and scores range of 0 to 32 from the Hep Subscale. Higher score in sub-score or total score indicates better QOL and better health state. Participants were classified as "Improved" if they had positive change from baseline, "Worsened" if they had negative change from baseline, and "Stable" otherwise.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had data for FACT-Hep questionnaire.'}, {'type': 'SECONDARY', 'title': 'Relationship of Steady-State Drug Levels to Clinical Outcomes of Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enzastaurin+Gemcitabine', 'description': 'Enzastaurin: 1200 milligrams (mg) administered orally (as three 400-mg doses) after a meal on Day 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 2 to 28 in Cycle 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 1 to 28 in Cycle 2 and later.\n\nGemcitabine: 1000 milligrams/square meter (mg/m\\^2) administered intravenously on Days 1, 8 and 15 of each 28-day cycle.'}], 'classes': [{'title': 'Below median', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '10.6'}]}]}, {'title': 'Above median', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '6.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to date of death from any cause up to 27.7 months', 'description': 'OS was the duration from randomization to death from any cause. For participants who were alive at data cut-off, OS was censored at the last contact. Participants were categorized into 2 groups based on their steady state drug levels of Enzastaurin (total analyte=enzastaurin + LSN326020 \\[metabolite\\]): those participants below the median and those participants above the median \\[2786.042 nanomoles per /liter (nmol/l)\\]. The steady state drug levels and clinical outcomes were not evaluated for the Gemcitabine only treatment group.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug. Participants censored: Below median = 4; Above median =4.'}, {'type': 'SECONDARY', 'title': 'Relationship of Steady-state Drug Levels to Best Overall Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Disease Control)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enzastaurin+Gemcitabine', 'description': 'Enzastaurin: 1200 milligrams (mg) administered orally (as three 400-mg doses) after a meal on Day 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 2 to 28 in Cycle 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 1 to 28 in Cycle 2 and later.\n\nGemcitabine: 1000 milligrams/square meter (mg/m\\^2) administered intravenously on Days 1, 8 and 15 of each 28-day cycle.'}], 'classes': [{'title': 'CR (Below median)', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '18.3'}]}]}, {'title': 'CR (Above median)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'PR (Below median)', 'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '36.9'}]}]}, {'title': 'PR (Above median)', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '18.3'}]}]}, {'title': 'SD (Below median)', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000', 'lowerLimit': '37.2', 'upperLimit': '75.5'}]}]}, {'title': 'SD (Above median)', 'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000', 'lowerLimit': '21.5', 'upperLimit': '59.4'}]}]}, {'title': 'PD (Below median)', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '32.7'}]}]}, {'title': 'PD (Above median)', 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000', 'lowerLimit': '15.9', 'upperLimit': '52.4'}]}]}, {'title': 'Disease Control (Below median)', 'categories': [{'measurements': [{'value': '78.6', 'groupId': 'OG000', 'lowerLimit': '59.0', 'upperLimit': '91.7'}]}]}, {'title': 'Disease Control (Above median)', 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000', 'lowerLimit': '24.5', 'upperLimit': '62.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Beginning of treatment up to 27.7 months', 'description': 'The overall disease control rate was calculated as percent of participants with overall response of complete response (CR), partial response (PR) or stable disease (SD) over number of per-protocol population. Using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria, CR: disappearance of all target and non-target lesions; PR: as at least a 30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD) was defined as at least 20% increase in sum of LD of target lesions; SD: small changes that did not meet above criteria.\n\nParticipants were categorized into 2 groups based on their steady state drug levels of Enzastaurin (total analyte=enzastaurin + LSN326020 \\[metabolite\\]): participants below the median and participants above the median \\[2754.521 nanomoles per liter (nmol/l)\\].\n\nThe steady state drug levels and clinical outcomes were not evaluated for the Gemcitabine only group.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who had: 1) Histological or cytological diagnosis of locally advanced (Stage II, III) or metastatic (Stage IV) adenocarcinoma of the pancreas; 2) no concurrent systemic chemotherapy; 3) presence of measurable disease at baseline; and 4) received at least 1 dose of study drug and had data for overall response.'}, {'type': 'SECONDARY', 'title': 'Carbohydrate Antigen 19-9 (CA 19-9) Concentration in the Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enzastaurin+Gemcitabine', 'description': 'Enzastaurin: 1200 milligrams (mg) administered orally (as three 400-mg doses) after a meal on Day 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 2 to 28 in Cycle 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 1 to 28 in Cycle 2 and later.\n\nGemcitabine: 1000 milligrams/square meter (mg/m\\^2) administered intravenously on Days 1, 8 and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Gemcitabine', 'description': 'Gemcitabine: 1000 mg/m\\^2 administered intravenously on Days 1, 8 and 15 of each 28-day cycle.'}], 'classes': [{'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '31708.5', 'spread': '134178.00', 'groupId': 'OG000'}, {'value': '12038.6', 'spread': '26659.50', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2', 'categories': [{'measurements': [{'value': '12828.4', 'spread': '33051.54', 'groupId': 'OG000'}, {'value': '40764.9', 'spread': '143995.67', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3', 'categories': [{'measurements': [{'value': '24709.5', 'spread': '114098.20', 'groupId': 'OG000'}, {'value': '1573.0', 'spread': '2811.74', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '37261.0', 'spread': '168939.81', 'groupId': 'OG000'}, {'value': '1102.7', 'spread': '1547.67', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5', 'categories': [{'measurements': [{'value': '392.3', 'spread': '744.91', 'groupId': 'OG000'}, {'value': '403.1', 'spread': '541.91', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6', 'categories': [{'measurements': [{'value': '600.9', 'spread': '1268.90', 'groupId': 'OG000'}, {'value': '938.5', 'spread': '1542.34', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment 1st visit', 'categories': [{'measurements': [{'value': '19420.5', 'spread': '45867.95', 'groupId': 'OG000'}, {'value': '11351.3', 'spread': '23890.66', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment 2nd visit', 'categories': [{'measurements': [{'value': '19557.7', 'spread': '32615.58', 'groupId': 'OG000'}, {'value': '93955.9', 'spread': '176684.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycles 1 to 6, and post-treatment (up to 27.7 months)', 'description': 'CA19-9 is a tumor biomarker which was measured in the blood to assess the effect of treatment with enzastaurin.', 'unitOfMeasure': 'kilo units/liter (kU/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) (Toxicity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enzastaurin+Gemcitabine', 'description': 'Enzastaurin: 1200 milligrams (mg) administered orally (as three 400-mg doses) after a meal on Day 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 2 to 28 in Cycle 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 1 to 28 in Cycle 2 and later.\n\nGemcitabine: 1000 milligrams/square meter (mg/m\\^2) administered intravenously on Days 1, 8 and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Gemcitabine', 'description': 'Gemcitabine: 1000 mg/m\\^2 administered intravenously on Days 1, 8 and 15 of each 28-day cycle.'}], 'classes': [{'title': 'Non-serious AEs', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Deaths due to PD', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Deaths due to AEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Deaths within 30-days after treatment', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through study completion (Up To 27.7 Months)', 'description': 'Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). Participants who died due to progressive disease (PD), AEs while on treatment or died during the 30 day post-treatment are included. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All participants who received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enzastaurin+Gemcitabine', 'description': 'Enzastaurin: 1200 milligrams (mg) administered orally (as three 400-mg doses) after a meal on Day 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 2 to 28 in Cycle 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 1 to 28 in Cycle 2 and later.\n\nGemcitabine: 1000 milligrams/square meter (mg/m\\^2) administered intravenously on Days 1, 8 and 15 of each 28-day cycle.'}, {'id': 'FG001', 'title': 'Gemcitabine', 'description': 'Gemcitabine: 1000 milligrams/square meter (mg/m\\^2) administered intravenously on Days 1, 8 and 15 of each 28-day cycle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'Received at Least 1 Dose', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'Per-Protocol Population', 'achievements': [{'comment': 'With: cancer of the pancreas;no other chemotherapy;disease at baseline;received 1 dose of study drug', 'groupId': 'FG000', 'numSubjects': '81'}, {'comment': 'With: cancer of the pancreas;no other chemotherapy;disease at baseline;received 1 dose of study drug', 'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '43'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Unrelated Complication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Sponsor Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Participant flow reports those participants who discontinued from study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Enzastaurin+Gemcitabine', 'description': 'Enzastaurin: 1200 milligrams (mg) administered orally (as three 400-mg doses) after a meal on Day 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 2 to 28 in Cycle 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 1 to 28 in Cycle 2 and later.\n\nGemcitabine: 1000 milligrams/square meter (mg/m\\^2) administered intravenously on Days 1, 8 and 15 of each 28-day cycle.'}, {'id': 'BG001', 'title': 'Gemcitabine', 'description': 'Gemcitabine: 1000 mg/m\\^2 administered intravenously on Days 1, 8 and 15 of each 28-day cycle.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.3', 'groupId': 'BG000', 'lowerLimit': '39.6', 'upperLimit': '86.7'}, {'value': '64.1', 'groupId': 'BG001', 'lowerLimit': '41.9', 'upperLimit': '83.4'}, {'value': '67.6', 'groupId': 'BG002', 'lowerLimit': '39.6', 'upperLimit': '86.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status', 'classes': [{'title': '0 - Fully Active', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': '1 - Ambulatory, Restricted Strenuous Activity', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}, {'title': '2 - Ambulatory, No Work Activities', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '\\[1\\] ECOG is a scale of participants activity Status 0 - Fully Active\n\n1. \\- Ambulatory, Restricted Strenuous Activity\n2. \\- Ambulatory, No Work Activities', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Body Surface Area (BSA)', 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '0.24', 'groupId': 'BG000'}, {'value': '1.9', 'spread': '0.21', 'groupId': 'BG001'}, {'value': '1.8', 'spread': '0.23', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'square meter (m^2)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diagnosis Stage', 'classes': [{'title': 'Stage IIA', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Stage IIB', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Stage III', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Stage IV', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body).\n\nStage IIA -The tumor is outside pancreas but not in large blood vessels or lymph nodes; Stage IIB: Cancer in or outside pancreas but not in large blood vessels; spread to nearby lymph nodes.\n\nStage III - The tumor is outside pancreas and spread to nearby large blood vessels or major nerves. May or may not have spread to nearby lymph nodes; not spread to distant sites.\n\nStage IV - the cancer has spread to other organs of the body such as the lung, brain, or liver.', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Current Stage', 'classes': [{'title': 'Stage IIB', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Stage III', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Stage IV', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body).\n\nStage IIB: Cancer in or outside pancreas but not in large blood vessels; spread to nearby lymph nodes.\n\nStage III - The tumor is outside pancreas and spread to nearby large blood vessels or major nerves. May or may not have spread to nearby lymph nodes; not spread to distant sites.\n\nStage IV - the cancer has spread to other organs of the body such as the lung, brain, or liver.', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) population: All randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'dispFirstSubmitDate': '2009-06-10', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-17', 'studyFirstSubmitDate': '2005-12-16', 'dispFirstSubmitQcDate': '2009-10-05', 'resultsFirstSubmitDate': '2020-06-09', 'studyFirstSubmitQcDate': '2005-12-16', 'dispFirstPostDateStruct': {'date': '2009-10-07', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-17', 'studyFirstPostDateStruct': {'date': '2005-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Randomization to the date of death from any cause up to 27.7 months', 'description': 'OS was the duration from randomization to death. OS was censored at the last contact for participants who were alive, at the cut-off date.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate)', 'timeFrame': 'Randomization to measured progressive disease (PD) up to 19.9 months', 'description': 'Response rate was defined as percentage of responders (best study response recorded as CR or PR) from the qualified number of participants for tumor response analysis. Response defined using Response Evaluation Criteria In Solid Tumors (RECIST, v1.0) criteria: CR was disappearance of all target lesions for at least 4 weeks. PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD.\n\nPercentage of participants was calculated as: (The number of responders with CR or PR/ The number of participants qualified for tumor response analysis) × 100.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Randomization to measured PD or death from any cause up to 21.6 months', 'description': 'PFS was defined as the time from the date of randomization to the first date of documented progressive disease (PD) or death due to any cause, whichever occurred first. PFS was censored at the date of the last assessment visit for participants who were still alive at data cut-off and who had not had documented progressive disease. Participants who started a new treatment before progression were censored as of the date of the start of new treatment.'}, {'measure': 'Duration of Response', 'timeFrame': 'Time of response to PD or death from any cause up to 19.9 months', 'description': 'The duration of a complete response (CR) or partial response (PR) was defined, using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria, as the time from first objective status assessment of CR or PR to the first time of disease progression or death as a result of any cause. Using the Response Evaluation Criteria in Solid Tumors (RECIST V1.0) criteria, CR was defined as the disappearance of all tumor lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD. Duration of response was censored at the date of the last assessment visit for responders who were still alive at data cut-off and had no documented progressive disease (PD).'}, {'measure': 'Change in Scores From Baseline (Improved, Stable or Worsened) to End of Study in Functional Assessment of Cancer Therapy Hepatobiliary Version 4 ( FACT-Hep v.4) (Quality of Life (QOL))', 'timeFrame': 'Baseline through end of study up to 27.7 months', 'description': 'FACT-Hep consists of 45 items in five subscales (1) physical well-being (PWB) score rage 0 -28; (2) social well-being (SWB) score range 0-28; (3) emotional well-being (EWB) score range 0-24; (4) functional well-being (FWB) score range 0-28; and (5) the hepatobiliary cancer subscale (HCS) Score range 0-72. The Trial Outcomes Index (TOI) is the sum of the PWB, FWB and Hep subscales with a scores range of 0 to 128. The Total FACT-Hep score was the sum of all questions with a scores range of 0 to 180. The Total FACT-G score was the sum of the 27 questions in the PWB, SFWB, EWB and FWB with a scores range of 0 to 108. The FACT-Hep Symptoms Index with 8 key questions and scores range of 0 to 32 from the Hep Subscale. Higher score in sub-score or total score indicates better QOL and better health state. Participants were classified as "Improved" if they had positive change from baseline, "Worsened" if they had negative change from baseline, and "Stable" otherwise.'}, {'measure': 'Relationship of Steady-State Drug Levels to Clinical Outcomes of Overall Survival (OS)', 'timeFrame': 'Randomization to date of death from any cause up to 27.7 months', 'description': 'OS was the duration from randomization to death from any cause. For participants who were alive at data cut-off, OS was censored at the last contact. Participants were categorized into 2 groups based on their steady state drug levels of Enzastaurin (total analyte=enzastaurin + LSN326020 \\[metabolite\\]): those participants below the median and those participants above the median \\[2786.042 nanomoles per /liter (nmol/l)\\]. The steady state drug levels and clinical outcomes were not evaluated for the Gemcitabine only treatment group.'}, {'measure': 'Relationship of Steady-state Drug Levels to Best Overall Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Disease Control)', 'timeFrame': 'Beginning of treatment up to 27.7 months', 'description': 'The overall disease control rate was calculated as percent of participants with overall response of complete response (CR), partial response (PR) or stable disease (SD) over number of per-protocol population. Using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria, CR: disappearance of all target and non-target lesions; PR: as at least a 30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD) was defined as at least 20% increase in sum of LD of target lesions; SD: small changes that did not meet above criteria.\n\nParticipants were categorized into 2 groups based on their steady state drug levels of Enzastaurin (total analyte=enzastaurin + LSN326020 \\[metabolite\\]): participants below the median and participants above the median \\[2754.521 nanomoles per liter (nmol/l)\\].\n\nThe steady state drug levels and clinical outcomes were not evaluated for the Gemcitabine only group.'}, {'measure': 'Carbohydrate Antigen 19-9 (CA 19-9) Concentration in the Blood', 'timeFrame': 'Cycles 1 to 6, and post-treatment (up to 27.7 months)', 'description': 'CA19-9 is a tumor biomarker which was measured in the blood to assess the effect of treatment with enzastaurin.'}, {'measure': 'Number of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) (Toxicity)', 'timeFrame': 'Baseline through study completion (Up To 27.7 Months)', 'description': 'Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). Participants who died due to progressive disease (PD), AEs while on treatment or died during the 30 day post-treatment are included. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pancreatic Neoplasm']}, 'referencesModule': {'references': [{'pmid': '12183093', 'type': 'BACKGROUND', 'citation': 'Yount S, Cella D, Webster K, Heffernan N, Chang C, Odom L, van Gool R. Assessment of patient-reported clinical outcome in pancreatic and other hepatobiliary cancers: the FACT Hepatobiliary Symptom Index. J Pain Symptom Manage. 2002 Jul;24(1):32-44. doi: 10.1016/s0885-3924(02)00422-0.'}], 'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to determine the effects and toxicity of gemcitabine alone or gemcitabine plus enzastaurin in participants with pancreatic cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of adenocarcinoma of the pancreas.\n* Pretreatment tumor specimen must be available.\n* No prior chemotherapy immunotherapy, biological therapy, or hormonal therapy for pancreatic cancer, including 5-fluorouracil (5-FU) with radiation therapy.\n* Prior radiation allowed.\n* Ability to stop some types of anti-seizure medicines within 14 days of enrollment.\n\nExclusion Criteria:\n\n* Endocrine pancreatic tumor or ampullary cancer.\n* Central Nervous System (CNS) metastases.\n* Inability to swallow tablets.\n* 10% or greater weight loss over the 6 weeks before study entry.'}, 'identificationModule': {'nctId': 'NCT00267020', 'briefTitle': 'Phase 2 Study of Gemcitabine or Gemcitabine + Enzastaurin in Participants With Advanced or Metastatic Pancreatic Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Open-Label Phase 2 Study of 2 Regimens, Gemcitabine Plus Enzastaurin and Single-Agent Gemcitabine, in Patients With Locally Advanced or Metastatic Pancreatic Cancer', 'orgStudyIdInfo': {'id': '10463'}, 'secondaryIdInfos': [{'id': 'H6Q-US-S002', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enzastaurin+Gemcitabine', 'interventionNames': ['Drug: enzastaurin', 'Drug: gemcitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gemcitabine', 'interventionNames': ['Drug: gemcitabine']}], 'interventions': [{'name': 'enzastaurin', 'type': 'DRUG', 'otherNames': ['LY317615'], 'description': '1200 milligrams (mg) loading dose then 500 mg, orally, daily, six 28-day cycles', 'armGroupLabels': ['Enzastaurin+Gemcitabine']}, {'name': 'gemcitabine', 'type': 'DRUG', 'otherNames': ['LY188011', 'Gemzar'], 'description': '1000 milligrams/square meter (mg/m\\^2), intravenously on Days 1, 8 and 15 per cycle, six 28-day cycles', 'armGroupLabels': ['Enzastaurin+Gemcitabine', 'Gemcitabine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], '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'}}}}