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Ignite Creation Date: 2025-12-25 @ 5:11 AM

Ignite Modification Date: 2025-12-26 @ 4:17 AM

Study NCT ID: NCT00593827

Status: COMPLETED

Last Update Posted: 2016-03-10

First Post: 2008-01-04

Is NOT Gene Therapy: False

Has Adverse Events: True

Brief Title: Phase II Trial of Weekly or Every 3-week Ixabepilone for Patients With Metastatic Breast Cancer

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C430592', 'term': 'ixabepilone'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'title': 'BMS Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the date of first study dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m2 arm; 3-87 weeks for 40 mg/m2 arm).', 'description': 'AEs and other symptoms were graded according to the CTCAE Version 3.0 and categorized according to Medical Dictionary for Regulatory Activities (MedDRA) Version 14.1.', 'eventGroups': [{'id': 'EG000', 'title': 'Ixabepilone 16 mg/m^2', 'description': 'ixabepilone 16 mg/m\\^2 weekly for 3 weeks followed by 1 week rest', 'otherNumAtRisk': 82, 'otherNumAffected': 82, 'seriousNumAtRisk': 82, 'seriousNumAffected': 25}, {'id': 'EG001', 'title': 'Ixabepilone 40 mg/m^2', 'description': 'ixabepilone 40 mg/m\\^2 every 3 weeks', 'otherNumAtRisk': 89, 'otherNumAffected': 89, 'seriousNumAtRisk': 89, 'seriousNumAffected': 30}], 'otherEvents': [{'term': 'allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 6}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 47}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 31}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'leucopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 54}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'dysguesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 39}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'gastroesophageal reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 24}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'infection fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'pain bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 39}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'neuropathy', 'notes': "For 13 participants in ixabepilone 16 mg/m2 group and 9 participants in ixabepilone 40 mg/m2 group, no detailed information indicated the 'neuropathy' as the 'peripheral neuropathy' or not.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'infection upper respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'infection bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'fibrillation atrial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'angina attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'congestive heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'flutter atrial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'arrest cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'cardiopulmonary arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'gastroparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'electrolyte abnormality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'gastrointestinal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'glucose blood increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'fracture pathological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'pain bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'effusion pleural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'distress respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'embolus pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'failure respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'infection bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone 16 mg/m^2', 'description': 'ixabepilone 16 mg/m\\^2 weekly for 3 weeks followed by 1 week rest'}, {'id': 'OG001', 'title': 'Ixabepilone 40 mg/m^2', 'description': 'ixabepilone 40 mg/m\\^2 every 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '18.9', 'upperLimit': '38.9'}, {'value': '42.7', 'groupId': 'OG001', 'lowerLimit': '31.5', 'upperLimit': '53.5'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization to 6-months on study', 'description': 'PFS at 6 months was defined as proportion of participants who neither progressed nor died before 6 months. Computed using Kaplan-Meier estimates.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: Participants who were randomized on the study (eligible and ineligible).'}, {'type': 'SECONDARY', 'title': 'Median Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone 16 mg/m^2', 'description': 'ixabepilone 16 mg/m\\^2 weekly for 3 weeks followed by 1 week rest'}, {'id': 'OG001', 'title': 'Ixabepilone 40 mg/m^2', 'description': 'ixabepilone 40 mg/m\\^2 every 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '5.1'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '6.2'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 25.7 months)', 'description': 'PFS is defined as time interval from the date of randomization to the date of (first) progression or date of death. Participants who progressed or died were counted as events. Participants lost to follow-up were censored as of the last date of contact. Participants who started a new treatment before they progressed were censored as of the date of start of the new treatment. Participants who had not progressed or died were censored at the date of last follow-up. PFS (months) = (End date - date of randomization + 1)/30.4375.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: Participants who were randomized on the study (eligible and ineligible).'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR) Based on Response Criteria in Solid Tumors [RECIST]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone 16 mg/m^2', 'description': 'ixabepilone 16 mg/m\\^2 weekly for 3 weeks followed by 1 week rest'}, {'id': 'OG001', 'title': 'Ixabepilone 40 mg/m^2', 'description': 'ixabepilone 40 mg/m\\^2 every 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '15.8'}, {'value': '13.5', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '22.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)', 'description': 'ORR is defined as the proportion of responders (complete response \\[CR\\] + partial response \\[PR\\] in participants with measurable disease) in that arm among all randomized participants.\n\nCR: Disappearance of all evidence of target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions.\n\nMeasurable disease: Lesions that can be accurately measured in at least one dimension (LD to be recorded) as ≥20 mm with conventional techniques (computed tomography \\[CT\\], magnetic resonance imaging \\[MRI\\], X-ray) or as ≥10 mm with spiral CT scan.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population-All treated participants with CR, PR, stable disease (SD), progressive disease (PD), or nonevaluable (NE) response and who had received at least 1 dose of study drug. Please refer outcome measure 4 for explanation of SD, PD, and NE.'}, {'type': 'SECONDARY', 'title': 'Best Response as Assessed With RECIST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone 16 mg/m^2', 'description': 'ixabepilone 16 mg/m\\^2 weekly for 3 weeks followed by 1 week rest'}, {'id': 'OG001', 'title': 'Ixabepilone 40 mg/m^2', 'description': 'ixabepilone 40 mg/m\\^2 every 3 weeks'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '0', 'comment': 'No participants had CR.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '6.1'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '15.8'}, {'value': '12.4', 'groupId': 'OG001', 'lowerLimit': '6.3', 'upperLimit': '21.0'}]}]}, {'title': 'SD', 'categories': [{'measurements': [{'value': '40.5', 'groupId': 'OG000', 'lowerLimit': '29.6', 'upperLimit': '52.1'}, {'value': '44.9', 'groupId': 'OG001', 'lowerLimit': '34.4', 'upperLimit': '55.9'}]}]}, {'title': 'SD>=6 months', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': '29.4'}, {'value': '15.7', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '25.0'}]}]}, {'title': 'PD', 'categories': [{'measurements': [{'value': '41.8', 'groupId': 'OG000', 'lowerLimit': '30.8', 'upperLimit': '53.4'}, {'value': '29.2', 'groupId': 'OG001', 'lowerLimit': '20.1', 'upperLimit': '39.8'}]}]}, {'title': 'NE', 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '19.0'}, {'value': '12.4', 'groupId': 'OG001', 'lowerLimit': '6.3', 'upperLimit': '21.0'}]}]}, {'title': 'CR+PR+SD>=6 mos', 'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000', 'lowerLimit': '17.3', 'upperLimit': '37.7'}, {'value': '29.2', 'groupId': 'OG001', 'lowerLimit': '20.1', 'upperLimit': '39.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)', 'description': 'Determined based on the sequence of disease status with corresponding best response. PD=At least a 20% increase in the sum of LD of target lesions in reference to the smallest sum LD recorded or the appearance of 1 or more new lesions; SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD in reference to the smallest sum LD. NE=Participants who discontinued treatment secondary to toxicity or died (either before completion of 1 treatment cycle). Please refer outcome measure 3 for explanation of CR and PR. CR+PR+SD=overall disease control.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population: All treated participants with CR, PR, SD, PD, or NE response and who had received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone 16 mg/m^2', 'description': 'ixabepilone 16 mg/m\\^2 weekly for 3 weeks followed by 1 week rest'}, {'id': 'OG001', 'title': 'Ixabepilone 40 mg/m^2', 'description': 'ixabepilone 40 mg/m\\^2 every 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': '15.7'}, {'value': '16.1', 'comment': 'Insufficient number of participants with an event were available to estimate the upper limit of the confidence interval.', 'groupId': 'OG001', 'lowerLimit': '10.3', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization to date of death (maximum participant OS of 26.3 months)', 'description': 'Survival was measured as the date of randomization to the date of death. Participants who were alive at the time of the database lock or lost to follow-up were censored at the last known alive date. The distribution of overall survival was analyzed via the Kaplan Meier method in each arm.\n\nSurvival time (months) = (End date - date of randomization + 1)/30.4375', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: Participants who were randomized on the study (eligible and ineligible).'}, {'type': 'SECONDARY', 'title': 'Time to Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone 16 mg/m^2', 'description': 'ixabepilone 16 mg/m\\^2 weekly for 3 weeks followed by 1 week rest'}, {'id': 'OG001', 'title': 'Ixabepilone 40 mg/m^2', 'description': 'ixabepilone 40 mg/m\\^2 every 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '8.3'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '8.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first dose to date of first PR or CR assessment ( maximum participant time to response of 8.3 months)', 'description': 'Time to response is defined as the time from the start of treatment until the first (confirmed) CR or PR was recorded. Time to response was computed only for participants whose best response was PR or CR.\n\nCR: Disappearance of all target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions with reference to the baseline sum LD.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with CR or PR.'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone 16 mg/m^2', 'description': 'ixabepilone 16 mg/m\\^2 weekly for 3 weeks followed by 1 week rest'}, {'id': 'OG001', 'title': 'Ixabepilone 40 mg/m^2', 'description': 'ixabepilone 40 mg/m\\^2 every 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'comment': 'Insufficient number of participants with an event were available to estimate the upper limit of the confidence interval.', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': 'NA'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '17.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 17.4 months)', 'description': 'Duration of overall response was defined as the period from the time first PR or CR was recorded until the first date of documented PD or death. Duration of response was computed for participants whose best response was either PR or CR. Participants who neither relapsed nor died were censored on the date of their last tumor assessment. Kaplan-Meier method was used to estimate the duration of response. Refer to outcome measures 3 and 4 for CR, PR, and PD.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with CR or PR.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone 16 mg/m^2', 'description': 'ixabepilone 16 mg/m\\^2 weekly for 3 weeks followed by 1 week rest'}, {'id': 'OG001', 'title': 'Ixabepilone 40 mg/m^2', 'description': 'ixabepilone 40 mg/m\\^2 every 3 weeks'}], 'classes': [{'title': 'Deaths (All)', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AEs leading to death (n=82; n=89)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'At least 1 SAE', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'At least 1 study-related SAE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'AEs leading to discontinuation', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'At least 1 AE (n=82; n=89)', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'At least 1 study-related AEs', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}, {'title': 'At least 1 GR 3 and 4 AEs (n=82; n=89)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'At least 1 study-related GR 3 and 4 AEs', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Drug-related peripheral neuropathy (All)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'GR 1 and 2 drug-related peripheral neuropathy', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'GR 3 drug-related peripheral neuropathy', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'GR 4 drug-related peripheral neuropathy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Drug-related neutropenia (All)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'GR 1 and 2 drug-related neutropenia', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'GR 3 drug-related neutropenia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'GR 4 drug-related neutropenia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Drug-related alopecia (All)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'GR 1 and 2 drug-related alopecia', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm).', 'description': 'An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. GR=Grade.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: Participants randomized on the study (eligible and ineligible). AEs, AEs leading to death and GR 3-4 AEs: Safety population-Participants who received atleast 1 dose of study drug).\n\nAEs leading to death: For 4 participants in Arm 1 and both participants in Arm 2, the reported AE term was "disease progression."'}, {'type': 'SECONDARY', 'title': 'Incidence of All Grades of Peripheral Neuropathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone 16 mg/m^2', 'description': 'ixabepilone 16 mg/m\\^2 weekly for 3 weeks followed by 1 week rest'}, {'id': 'OG001', 'title': 'Ixabepilone 40 mg/m^2', 'description': 'ixabepilone 40 mg/m\\^2 every 3 weeks'}], 'classes': [{'title': 'All', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Grade 1', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed from the date of first study dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm).', 'description': 'All events of peripheral neuropathy were assessed and graded per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3. CTC Grade (GR) 1=Mild; GR2=Moderate; GR3=Severe or medically significant, not immediately life-threatening; and GR4=Life-threatening. All treatment-related and not related Neuropathy and Peripheral Neuropathy were included; serious adverse events (SAEs) were not included.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ixabepilone 16 mg/m^2', 'description': 'ixabepilone 16 mg/m\\^2 weekly for 3 weeks followed by 1 week rest'}, {'id': 'FG001', 'title': 'Ixabepilone 40 mg/m^2', 'description': 'ixabepilone 40 mg/m\\^2 every 3 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Intent-to-Treat (ITT) Population: Participants who were randomized (eligible and ineligible).', 'groupId': 'FG000', 'numSubjects': '85'}, {'comment': 'ITT Population: Participants who were randomized (eligible and ineligible).', 'groupId': 'FG001', 'numSubjects': '91'}]}, {'type': 'Safety Population', 'achievements': [{'comment': 'Participants (eligible and ineligible) who received at least 1 dose of study drug.', 'groupId': 'FG000', 'numSubjects': '82'}, {'comment': 'Participants (eligible and ineligible) who received at least 1 dose of study drug.', 'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'Evaluable Population', 'achievements': [{'comment': 'Treated participants with CR, PR, SD, PD, or NE response. Refer outcome measure 3 and 4 for details.', 'groupId': 'FG000', 'numSubjects': '79'}, {'comment': 'Treated participants with CR, PR, SD, PD, or NE response. Refer outcome measure 3 and 4 for details.', 'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed=off-study (Major reasons: Adverse events (AE)=15; disease progression=76; not treated=3).', 'groupId': 'FG000', 'numSubjects': '85'}, {'comment': 'Completed=off-study (Major reasons: AEs=30; disease progression=55; not treated=2).', 'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'On Active Treatment/Pending', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'A total of 176 participants were enrolled by 55 sites in the United States over a period of 12 months.', 'preAssignmentDetails': 'All the 176 enrolled participants were randomized. Of the 5 participants who did not receive treatment, 2 were due to disease progression, 1 on participant request, and 2 due to other reasons.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ixabepilone 16 mg/m^2', 'description': 'ixabepilone 16 mg/m\\^2 weekly for 3 weeks followed by 1 week rest'}, {'id': 'BG001', 'title': 'Ixabepilone 40 mg/m^2', 'description': 'ixabepilone 40 mg/m\\^2 every 3 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.3', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '58.7', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '59.5', 'spread': '10.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)', 'classes': [{'title': '0=normal activity', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}, {'title': '1=symptoms, but fully ambulatory', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}, {'title': '2=symptomatic, but in bed < 50% of the day', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'The ECOG PS is used to assess disease severity. A score of 0 is normal activity; 1 is symptoms, but fully ambulatory; 2 is symptomatic, but in bed \\< 50% of the day; 3 is needs to be in bed \\> 50% of the day, but not bedridden; 4 is unable to get out of bed; 5 is dead.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-09', 'studyFirstSubmitDate': '2008-01-04', 'resultsFirstSubmitDate': '2012-03-14', 'studyFirstSubmitQcDate': '2008-01-04', 'lastUpdatePostDateStruct': {'date': '2016-03-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-25', 'studyFirstPostDateStruct': {'date': '2008-01-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia', 'timeFrame': 'Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm).', 'description': 'An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. GR=Grade.'}], 'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months', 'timeFrame': 'From the date of randomization to 6-months on study', 'description': 'PFS at 6 months was defined as proportion of participants who neither progressed nor died before 6 months. Computed using Kaplan-Meier estimates.'}], 'secondaryOutcomes': [{'measure': 'Median Progression Free Survival', 'timeFrame': 'From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 25.7 months)', 'description': 'PFS is defined as time interval from the date of randomization to the date of (first) progression or date of death. Participants who progressed or died were counted as events. Participants lost to follow-up were censored as of the last date of contact. Participants who started a new treatment before they progressed were censored as of the date of start of the new treatment. Participants who had not progressed or died were censored at the date of last follow-up. PFS (months) = (End date - date of randomization + 1)/30.4375.'}, {'measure': 'Overall Response Rate (ORR) Based on Response Criteria in Solid Tumors [RECIST]', 'timeFrame': 'Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)', 'description': 'ORR is defined as the proportion of responders (complete response \\[CR\\] + partial response \\[PR\\] in participants with measurable disease) in that arm among all randomized participants.\n\nCR: Disappearance of all evidence of target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions.\n\nMeasurable disease: Lesions that can be accurately measured in at least one dimension (LD to be recorded) as ≥20 mm with conventional techniques (computed tomography \\[CT\\], magnetic resonance imaging \\[MRI\\], X-ray) or as ≥10 mm with spiral CT scan.'}, {'measure': 'Best Response as Assessed With RECIST', 'timeFrame': 'Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)', 'description': 'Determined based on the sequence of disease status with corresponding best response. PD=At least a 20% increase in the sum of LD of target lesions in reference to the smallest sum LD recorded or the appearance of 1 or more new lesions; SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD in reference to the smallest sum LD. NE=Participants who discontinued treatment secondary to toxicity or died (either before completion of 1 treatment cycle). Please refer outcome measure 3 for explanation of CR and PR. CR+PR+SD=overall disease control.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From the date of randomization to date of death (maximum participant OS of 26.3 months)', 'description': 'Survival was measured as the date of randomization to the date of death. Participants who were alive at the time of the database lock or lost to follow-up were censored at the last known alive date. The distribution of overall survival was analyzed via the Kaplan Meier method in each arm.\n\nSurvival time (months) = (End date - date of randomization + 1)/30.4375'}, {'measure': 'Time to Response', 'timeFrame': 'From the date of first dose to date of first PR or CR assessment ( maximum participant time to response of 8.3 months)', 'description': 'Time to response is defined as the time from the start of treatment until the first (confirmed) CR or PR was recorded. Time to response was computed only for participants whose best response was PR or CR.\n\nCR: Disappearance of all target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions with reference to the baseline sum LD.'}, {'measure': 'Duration of Response', 'timeFrame': 'From the date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 17.4 months)', 'description': 'Duration of overall response was defined as the period from the time first PR or CR was recorded until the first date of documented PD or death. Duration of response was computed for participants whose best response was either PR or CR. Participants who neither relapsed nor died were censored on the date of their last tumor assessment. Kaplan-Meier method was used to estimate the duration of response. Refer to outcome measures 3 and 4 for CR, PR, and PD.'}, {'measure': 'Incidence of All Grades of Peripheral Neuropathy', 'timeFrame': 'Assessed from the date of first study dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm).', 'description': 'All events of peripheral neuropathy were assessed and graded per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3. CTC Grade (GR) 1=Mild; GR2=Moderate; GR3=Severe or medically significant, not immediately life-threatening; and GR4=Life-threatening. All treatment-related and not related Neuropathy and Peripheral Neuropathy were included; serious adverse events (SAEs) were not included.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metastatic Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine the effects of the weekly regimen of ixabepilone dosing compared to the once every 3 week dosing regimen in participants with metastatic breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has MBC that is measurable by RECIST or has nonmeasurable disease with serum CA27.29 (or CA15.3) ≥ 50\n* Has Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer\n* Prior chemotherapy is permitted with no limit on the number of prior regimens\n* Two weeks or more have elapsed since last chemotherapy or radiation treatment\n* Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2\n* Is female, ≥ 18 yrs of age\n* Protocol defined appropriate laboratory values\n* Negative pregnancy test within 7 calendar days prior to registration\n* Has signed a patient informed consent\n\nExclusion Criteria:\n\n* Had prior treatment with ixabepilone or other epothilones\n* Has HER2+ disease\n* Has a known, prior, severe (National Cancer Institute Common Terminology Criteria Adverse Events \\[NCI CTCAE\\] Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor ® EL (polyoxyethylated castor oil)\n* Is receiving concurrent immunotherapy, hormonal therapy or radiation therapy\n* Is receiving concurrent investigational therapy or has received such therapy within the past 30 days\n* Has peripheral neuropathy \\> Grade 1\n* Has evidence of central nervous system (CNS) involvement requiring radiation or steroid treatment. Participants with stable brain metastases who are off steroids at least 2 weeks are eligible\n* Is pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT00593827', 'briefTitle': 'Phase II Trial of Weekly or Every 3-week Ixabepilone for Patients With Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'R-Pharm'}, 'officialTitle': 'Phase II Randomized Trial of Weekly and Every 3-week Ixabepilone in Metastatic Breast Cancer (MBC) Patients', 'orgStudyIdInfo': {'id': 'CA163-132'}, 'secondaryIdInfos': [{'id': 'USOR 06-106'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1', 'description': 'ixabepilone 16 mg/m\\^2 weekly for 3 weeks followed by 1 week rest', 'interventionNames': ['Drug: Ixabepilone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': 'ixabepilone 40 mg/m\\^2 every 3 weeks', 'interventionNames': ['Drug: Ixabepilone']}], 'interventions': [{'name': 'Ixabepilone', 'type': 'DRUG', 'otherNames': ['IXEMPRA', 'BMS-247550'], 'description': 'Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 16 mg/m\\^2 was administered as a 1-hour IV continuous infusion on Days 1, 8, and 15 in a 28-day cycle until progressive disease or intolerable toxicity.', 'armGroupLabels': ['Arm 1']}, {'name': 'Ixabepilone', 'type': 'DRUG', 'otherNames': ['IXEMPRA', 'BMS-247550'], 'description': 'Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 40 mg/m\\^2 was administered as a 3-hour IV infusion on Day 1 of each 21-day cycle provided the subject met the retreatment criteria.', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham Hematology & Oncology Associates Llc', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 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