Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-27 @ 3:12 AM
Study NCT ID:
NCT01423604
Status:
COMPLETED
Last Update Posted:
2018-02-12
First Post:
2011-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Ruxolitinib in Pancreatic Cancer Patients
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': 'D000069287', 'term': 'Capecitabine'}, {'id': 'C540383', 'term': 'ruxolitinib'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-855-463-3463', 'title': 'Study Director', 'organization': 'Incyte Corporation'}, 'certainAgreement': {'otherDetails': 'Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study; provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).', 'description': 'Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Ruxolitinib (Safety Run-In)', 'description': 'Subjects received capecitabine 2000 mg/m\\^2 daily (taken as 1000 mg/m2 twice daily \\[BID\\]) + ruxolitinib 15 mg BID', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Ruxolitinib', 'description': 'Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m\\^2 (1000 mg/m\\^2 twice a day \\[BID\\]).', 'otherNumAtRisk': 59, 'otherNumAffected': 57, 'seriousNumAtRisk': 59, 'seriousNumAffected': 32}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m\\^2 (1000 mg/m\\^2 twice a day \\[BID\\]).', 'otherNumAtRisk': 60, 'otherNumAffected': 59, 'seriousNumAtRisk': 60, 'seriousNumAffected': 35}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Palmar-plantar erythrodysesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 19}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'International normalized ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 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of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Colostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Staphylococcal Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Streptococcal Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Prothrombin Time Prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Mucosal Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Shock Haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m\\^2 (1000 mg/m\\^2 twice a day \\[BID\\]).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m\\^2 (1000 mg/m\\^2 twice a day \\[BID\\]).'}], 'classes': [{'categories': [{'measurements': [{'value': '136.5', 'groupId': 'OG000', 'lowerLimit': '95.0', 'upperLimit': '196.0'}, {'value': '129.5', 'groupId': 'OG001', 'lowerLimit': '71.0', 'upperLimit': '179.0'}]}]}], 'analyses': [{'pValue': '0.0494', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.733', 'ciLowerLimit': '0.506', 'ciUpperLimit': '1.061', 'pValueComment': 'One-sided p-value.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0081', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.502', 'ciLowerLimit': '0.281', 'ciUpperLimit': '0.888', 'pValueComment': 'One-sided p-value.', 'groupDescription': 'Cox Regression Analysis of Overall Survival: C-reactive protein (CRP) \\> 13 μg/ml; Statistical analysis plan (SAP) specified subgroup analysis', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Primary analysis includes study data from the start of the study (first dose for that subject) until the death of the subject (up to 8 months).', 'description': 'Overall survival was measured as the length of time (in days) between the randomization date and the date of death.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m\\^2 (1000 mg/m\\^2 twice a day \\[BID\\]).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m\\^2 (1000 mg/m\\^2 twice a day \\[BID\\]).'}], 'classes': [{'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000', 'lowerLimit': '42.0', 'upperLimit': '84.0'}, {'value': '46.0', 'groupId': 'OG001', 'lowerLimit': '41.0', 'upperLimit': '70.0'}]}]}], 'analyses': [{'pValue': '0.1340', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Efron approximation of hazard ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.750', 'ciLowerLimit': '0.513', 'ciUpperLimit': '1.094', 'pValueComment': 'Two-sided p-value.', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Analysis includes study data from the start of the study (first dose for that subject) until death or PD, whichever was earlier up to 8 months.', 'description': 'Progression-free survival was defined as the length of time between the date of randomization and the earlier of death or progressive disease (PD), whichever was earlier, as assessed by RECIST. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m\\^2 (1000 mg/m\\^2 twice a day \\[BID\\]).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m\\^2 (1000 mg/m\\^2 twice a day \\[BID\\]).'}], 'classes': [{'title': 'Overall response', 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Complete response', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Partial response', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured every 4 weeks for duration of study treatment (up to 8 months)', 'description': 'Objective response rate (ORR) was defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) measured by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria during the treatment period. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.'}, {'type': 'SECONDARY', 'title': 'Durable Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m\\^2 (1000 mg/m\\^2 twice a day \\[BID\\]).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m\\^2 (1000 mg/m\\^2 twice a day \\[BID\\]).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0236', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Pearson's chi-square test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)', 'description': 'Durable response was defined as subjects with a response of Partial response (PR) or better at 2 subsequent measurements that were at least 4 weeks apart.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.'}, {'type': 'SECONDARY', 'title': 'Summary of Clinical Benefit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ruxolitinib', 'description': 'Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m\\^2 (1000 mg/m\\^2 twice a day \\[BID\\]).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m\\^2 (1000 mg/m\\^2 twice a day \\[BID\\]).'}], 'classes': [{'title': 'Subjects with clinical benefit', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Pain intensity - Improved', 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Analgesic use - Improved', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Karnofsky performance status - Improved', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Body weight - Improved', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)', 'description': 'A subject was considered a clinical benefit responder if he/she met at least 1 of the following criteria:\n\n1. Subject showed improvement in at least one of the following parameters on successive scheduled observations without worsening in the others: pain intensity, analgesic use, or performance status\n2. Subject was stable or improved on the pain intensity, analgesic use, and performance status and had a ≥ 7% increase in body weight maintained for 2 consecutive reporting periods that was not because of fluid accumulation.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ruxolitinib', 'description': 'Part 1: Subjects received capecitabine 2000 mg/m\\^2 (1000 mg/m\\^2 twice a day (BID)) + ruxolitinib 15 mg BID.\n\nPart 2: Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m\\^2 (1000 mg/m\\^2 twice a day \\[BID\\]).'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Part 2: Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m\\^2 (1000 mg/m\\^2 twice a day \\[BID\\]).'}], 'periods': [{'title': 'Safety Run-In', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Patient decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Randomized', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'As of 07August2015, 1 subject was receiving treatment in the randomized portion.', 'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '63'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Other - unspecified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'Patient decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'The open-label, safety run-in (1 cohort) was designed to confirm the safety of the combination of ruxolitinib and capecitabine in subjects with advanced or metastatic adenocarcinoma of the pancreas. The double-blind portion was 2 treatment groups randomized 1:1: ruxolitinib plus capecitabine or matching placebo plus capecitabine.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Ruxolitinib - Safety Run-In', 'description': 'Subjects received capecitabine 2000 mg/m\\^2 (1000 mg/m\\^2 twice a day \\[BID\\]) + ruxolitinib at 15 mg BID.'}, {'id': 'BG001', 'title': 'Ruxolitinib', 'description': 'Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m\\^2 (1000 mg/m\\^2 twice a day \\[BID\\]).'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m\\^2 (1000 mg/m\\^2 twice a day \\[BID\\]).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.6', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '65.7', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '66.3', 'spread': '9.8', 'groupId': 'BG002'}, {'value': '66.0', 'spread': '9.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '129', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '113', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '171.67', 'spread': '14.11', 'groupId': 'BG000'}, {'value': '171.29', 'spread': '11.93', 'groupId': 'BG001'}, {'value': '168.27', 'spread': '10.25', 'groupId': 'BG002'}, {'value': '169.78', 'spread': '11.18', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Treatment Group Ruxolitinib (N = 60); Placebo (N = 60)', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '75.051', 'spread': '17.317', 'groupId': 'BG000'}, {'value': '75.014', 'spread': '21.914', 'groupId': 'BG001'}, {'value': '69.299', 'spread': '16.260', 'groupId': 'BG002'}, {'value': '72.156', 'spread': '19.427', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Treatment Group Ruxolitinib (N = 60); Placebo (N = 60)', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '25.3', 'spread': '4.209', 'groupId': 'BG000'}, {'value': '25.354', 'spread': '6.332', 'groupId': 'BG001'}, {'value': '24.243', 'spread': '4.237', 'groupId': 'BG002'}, {'value': '24.789', 'spread': '5.394', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Treatment Group Ruxolitinib (N = 60); Placebo (N = 60)', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body surface area', 'classes': [{'categories': [{'measurements': [{'value': '1.869', 'spread': '0.287', 'groupId': 'BG000'}, {'value': '1.863', 'spread': '0.297', 'groupId': 'BG001'}, {'value': '1.791', 'spread': '0.248', 'groupId': 'BG002'}, {'value': '1.827', 'spread': '0.275', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Treatment Group Ruxolitinib (N = 60); Placebo (N = 60)', 'unitOfMeasure': 'm^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'dispFirstSubmitDate': '2014-04-04', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-15', 'studyFirstSubmitDate': '2011-08-22', 'dispFirstSubmitQcDate': '2014-04-04', 'resultsFirstSubmitDate': '2016-04-01', 'studyFirstSubmitQcDate': '2011-08-24', 'dispFirstPostDateStruct': {'date': '2014-05-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-07-19', 'studyFirstPostDateStruct': {'date': '2011-08-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Primary analysis includes study data from the start of the study (first dose for that subject) until the death of the subject (up to 8 months).', 'description': 'Overall survival was measured as the length of time (in days) between the randomization date and the date of death.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Analysis includes study data from the start of the study (first dose for that subject) until death or PD, whichever was earlier up to 8 months.', 'description': 'Progression-free survival was defined as the length of time between the date of randomization and the earlier of death or progressive disease (PD), whichever was earlier, as assessed by RECIST. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions'}, {'measure': 'Objective Response Rate', 'timeFrame': 'Measured every 4 weeks for duration of study treatment (up to 8 months)', 'description': 'Objective response rate (ORR) was defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) measured by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria during the treatment period. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.'}, {'measure': 'Durable Response Rate', 'timeFrame': 'Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)', 'description': 'Durable response was defined as subjects with a response of Partial response (PR) or better at 2 subsequent measurements that were at least 4 weeks apart.'}, {'measure': 'Summary of Clinical Benefit', 'timeFrame': 'Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)', 'description': 'A subject was considered a clinical benefit responder if he/she met at least 1 of the following criteria:\n\n1. Subject showed improvement in at least one of the following parameters on successive scheduled observations without worsening in the others: pain intensity, analgesic use, or performance status\n2. Subject was stable or improved on the pain intensity, analgesic use, and performance status and had a ≥ 7% increase in body weight maintained for 2 consecutive reporting periods that was not because of fluid accumulation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Metastatic pancreatic cancer'], 'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '26351344', 'type': 'DERIVED', 'citation': 'Hurwitz HI, Uppal N, Wagner SA, Bendell JC, Beck JT, Wade SM 3rd, Nemunaitis JJ, Stella PJ, Pipas JM, Wainberg ZA, Manges R, Garrett WM, Hunter DS, Clark J, Leopold L, Sandor V, Levy RS. Randomized, Double-Blind, Phase II Study of Ruxolitinib or Placebo in Combination With Capecitabine in Patients With Metastatic Pancreatic Cancer for Whom Therapy With Gemcitabine Has Failed. J Clin Oncol. 2015 Dec 1;33(34):4039-47. doi: 10.1200/JCO.2015.61.4578. Epub 2015 Sep 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine whether ruxolitinib added to capecitabine is effective in improving the overall survival of patients with metastatic pancreatic cancer.', 'detailedDescription': 'The study consisted of an open-label, safety run-in period that was composed of 1 patient cohort with 9 patients/cohort. This phase of the study determined the safety of the capecitabine/ruxolitinib combination in this patient population.\n\nA randomized, double-blind study with two treatment arms was conducted once the safety run-in results from the first part of the study showed that the capecitabine/ruxolitinib combination was safe and additional patients could be treated. All patients have received capecitabine therapy in addition to the ruxolitinib or placebo (Study Drug).\n\nTreatment for all patients consisted of repeating 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and the Study Drug was self-administered during the entire 21-day cycle. Treatment cycles continued as long as the regimen was tolerated and the patient did not meet any of the discontinuation criteria. In the event of disease progression, capecitabine therapy was discontinued but the Study Drug could continue to be administered. Subjects who discontinued treatment with the Study Drug continued to be followed to obtain information regarding subsequent treatment regimens and survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Diagnosis of metastatic pancreatic cancer; subjects must have had measurable, or evaluable disease that was histologically confirmed\n* Karnofsky performance status of ≥ 60\n* Subjects must have failed 1st-line gemcitabine treatment for metastatic pancreatic cancer:\n\n o An alternate chemotherapeutic agent was an acceptable substitute as 1st-line therapy in the event that the subject was intolerant to or ineligible to receive gemcitabine\n* ≥ 2 weeks elapsed from the completion of previous chemotherapy, and subjects must have recovered or been at new stable baseline from any related toxicities\n\nExclusion Criteria:\n\n* More than 1 prior chemotherapy regimen (not including adjuvant therapy) for metastatic disease\n* Evidence of central nervous system (CNS) metastases (unless stable for \\> 3 months) or history of uncontrolled seizures\n* Ongoing radiation therapy or prior radiation therapy administered as a second-line treatment\n* Other active malignancy except basal or squamous carcinoma of the skin\n* Inability to swallow food or any condition of the upper GI tract that precluded administration of oral medications\n* Inadequate renal, hepatic and bone marrow function demonstrated by clinical observations and/or laboratory assessments'}, 'identificationModule': {'nctId': 'NCT01423604', 'acronym': 'RECAP', 'briefTitle': 'Study of Ruxolitinib in Pancreatic Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Randomized Phase 2 Study of Ruxolitinib Efficacy and Safety in Combination With Capecitabine for Subjects With Recurrent or Treatment Refractory Metastatic Pancreatic Cancer (The RECAP Trial)', 'orgStudyIdInfo': {'id': '18424-262'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Capecitabine and ruxolitinib', 'interventionNames': ['Drug: Capecitabine', 'Drug: Ruxolitinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Capecitabine and placebo', 'interventionNames': ['Drug: Capecitabine', 'Drug: Placebo']}], 'interventions': [{'name': 'Capecitabine', 'type': 'DRUG', 'description': 'Capecitabine starting dose - 2000 mg/m\\^2 (1000 mg/m\\^2 twice a day (BID)) (NOTE: Frequency of administration may be adjusted during the study.)', 'armGroupLabels': ['Capecitabine and placebo', 'Capecitabine and ruxolitinib']}, {'name': 'Ruxolitinib', 'type': 'DRUG', 'description': 'Ruxolitinib starting dose - 15 mg BID (NOTE: Starting dose of randomized study drug may be 10 mg BID based on results from safety run-in study. Dose of ruxolitinib may be increased during randomized study.)', 'armGroupLabels': ['Capecitabine and ruxolitinib']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo matching ruxolitinib', 'armGroupLabels': ['Capecitabine and placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'city': 'Burbank', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'city': 'Elks Grove Village', 'state': 'Illinois', 'country': 'United States'}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'city': 'Novi', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.48059, 'lon': -83.47549}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'city': 'Bend', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 44.05817, 'lon': -121.31531}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}], 'overallOfficials': [{'name': 'William Williams, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Incyte Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}