Viewing Study NCT00082433

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Ignite Creation Date: 2025-12-25 @ 2:44 AM
Ignite Modification Date: 2025-12-31 @ 6:39 PM
Study NCT ID: NCT00082433
Status: COMPLETED
Last Update Posted: 2020-11-02
First Post: 2004-05-07
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced 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': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C430592', 'term': 'ixabepilone'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D034261', 'term': 'Epothilones'}], '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'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'title': 'Bristol-Myers Squibb 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': {'eventGroups': [{'id': 'EG000', 'title': 'Capecitabine', 'otherNumAtRisk': 603, 'otherNumAffected': 564, 'seriousNumAtRisk': 603, 'seriousNumAffected': 192}, {'id': 'EG001', 'title': 'Ixabepilone + Capecitabine', 'otherNumAtRisk': 595, 'otherNumAffected': 590, 'seriousNumAtRisk': 595, 'seriousNumAffected': 205}], 'otherEvents': [{'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 104}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 194}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'WEIGHT INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'HAEMOGLOBIN DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 44}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PLATELET COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 33}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'NEUTROPHIL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 67}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'WHITE BLOOD CELL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 44}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 84}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 97}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 69}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'DYSGEUSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 67}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'HYPOREFLEXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 37}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PARAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 115}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'NEUROPATHY PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 46}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PERIPHERAL MOTOR NEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 56}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PERIPHERAL SENSORY NEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 258}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 243}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 315}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 168}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 250}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 244}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 266}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 51}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'STOMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 118}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 161}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 88}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 55}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'ANOREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 183}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 69}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 85}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 159}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 68}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'ALOPECIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 245}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'DRY SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 51}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 34}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 31}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'NAIL DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 193}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'SKIN HYPERPIGMENTATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 79}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 412}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 383}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 146}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 70}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'BONE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 55}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 119}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'MUSCULAR WEAKNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 30}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 112}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 85}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 89}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 99}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 166}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 272}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 84}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 128}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 63}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'MUCOSAL INFLAMMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 79}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'seriousEvents': [{'term': 'EYE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'ECTROPION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'EYELID PTOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'VISUAL DISTURBANCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'BLINDNESS UNILATERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'ULCERATIVE KERATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'DIAGNOSTIC PROCEDURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'HAEMOGLOBIN DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'BLOOD ALBUMIN DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PLATELET COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'BLOOD PHOSPHORUS INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'NEUTROPHIL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PROTHROMBIN TIME PROLONGED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'WHITE BLOOD CELL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PERICARDITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'ANGINA UNSTABLE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'CARDIAC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'SINUS TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PERICARDIAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'OVERDOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'DRUG TOXICITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'ANKLE FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'FEMUR FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'TIBIA FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'WRIST FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'FIBULA FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PELVIC FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'INCISIONAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'LOWER LIMB FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PUBIC RAMI FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'TRACHEAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'TRANSFUSION REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'FEMORAL NECK FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PROCEDURAL COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'LUMBAR VERTEBRAL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'BONE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'FLANK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PATHOLOGICAL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'MUSCULOSKELETAL CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'SYSTEMIC LUPUS ERYTHEMATOSUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'HYPOXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'ALVEOLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PNEUMONITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PNEUMOTHORAX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'LUNG DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PLEURITIC PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PULMONARY OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'ACUTE RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'ACUTE RESPIRATORY DISTRESS SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'HYPOTHERMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'SUDDEN DEATH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'EXTRAVASATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'CATHETER THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'MULTI-ORGAN FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'CATHETER SITE OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'MUCOSAL INFLAMMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'INJECTION SITE EXTRAVASATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PERFORMANCE STATUS DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'GENERAL PHYSICAL HEALTH DETERIORATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'TUMOUR PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'COLON CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'BREAST CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'BREAST NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'MALIGNANT ASCITES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'MALIGNANT MELANOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'METASTASES TO BONE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'METASTASES TO LUNG', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'BREAST CANCER METASTATIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'MALIGNANT PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'MALIGNANT NEOPLASM PROGRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 17}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'PERICARDIAL EFFUSION MALIGNANT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'METASTASES TO CENTRAL NERVOUS SYSTEM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 603, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 595, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone + Capecitabine', 'description': 'Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.'}, {'id': 'OG001', 'title': 'Capecitabine', 'description': 'Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.24', 'groupId': 'OG000', 'lowerLimit': '5.59', 'upperLimit': '6.77'}, {'value': '4.40', 'groupId': 'OG001', 'lowerLimit': '4.14', 'upperLimit': '5.42'}]}]}], 'analyses': [{'pValue': '.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '.79', 'ciLowerLimit': '.69', 'ciUpperLimit': '.90', 'groupDescription': 'The analysis was conducted when 903 progressions or deaths (446 in combination:457 in capecitabine) were observed in 960 participants.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'every 6 weeks (± 3 days) from randomization while on treatment until documented progression', 'description': 'PFS was defined for each patient as the time in months from randomization to the date of progression. Patients who died without a reported prior progression were considered to have progressed on their date of death. Patients who did not progress or die were censored on the date of their last tumor assessment.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients with measurable disease as stratified at the time of randomization; n=480 and n=480 for the 2 treatment groups, respectively. Analysis was conducted once 903 progressions or deaths were observed in 960 participants.'}, {'type': 'SECONDARY', 'title': 'Response Rate (RR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone + Capecitabine', 'description': 'Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.'}, {'id': 'OG001', 'title': 'Capecitabine', 'description': 'Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.3', 'groupId': 'OG000', 'lowerLimit': '38.7', 'upperLimit': '47.9'}, {'value': '28.8', 'groupId': 'OG001', 'lowerLimit': '24.7', 'upperLimit': '33.2'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.89', 'ciLowerLimit': '1.44', 'ciUpperLimit': '2.50', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'every 6 weeks (± 3 days) from randomization while on treatment until documented progression', 'description': 'RR=number of patients in that group whose best response is "partial"(30% decrease in the sum of the longest diameter of target lesions) or "complete" (disappearance of all target lesions), according to the 4-item Response Evaluation Criteria in Solid Tumors (RECIST), divided by the total number of response-evaluable participants', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response-evaluable participants (all treated participants with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline).'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone + Capecitabine', 'description': 'Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.'}, {'id': 'OG001', 'title': 'Capecitabine', 'description': 'Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '7.0'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '7.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'every 6 weeks (± 3 days) from randomization while on treatment until documented progression', 'description': 'Measured from the time RECIST criteria (described in previous outcome measure) were first met for "complete" or "partial" response until first date of documented disease progression or death. Patients who neither relapsed nor died were censored on the date of last tumor assessment. Median w/ 95% CI estimated using Kaplan Meier Product Limit Method.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response-evaluable participants (all treated patients with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline)'}, {'type': 'SECONDARY', 'title': 'Time to Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone + Capecitabine', 'description': 'Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.'}, {'id': 'OG001', 'title': 'Capecitabine', 'description': 'Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '47.9'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '59.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'every 6 weeks (± 3 days) from randomization while on treatment until documented progression', 'description': 'Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for "partial" or "complete" (whichever status was recorded first) per RECIST criteria (a 4-item scale described in the previous outcome measure).', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Response-evaluable participants (all treated patients with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline)'}, {'type': 'SECONDARY', 'title': 'Treatment-Related Safety Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '595', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone + Capecitabine', 'description': 'Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.'}, {'id': 'OG001', 'title': 'Capecitabine', 'description': 'Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.'}], 'classes': [{'title': 'Deaths within 30 days of last dose', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related serious adverse events', 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related Grade 3-4 adverse events', 'categories': [{'measurements': [{'value': '458', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related AEs leading to discontinuation', 'categories': [{'measurements': [{'value': '286', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.', 'description': "Laboratory values, adverse events, and other symptoms were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTC) Version 3.0", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least 1 dose of ixabepilone and/or capecitabine. Participants with baseline hepatic impairment (combination arm, n = 50; capecitabine arm, n = 37), defined as Grade ≥2 AST, ALT or Grade ≥1 total bilirubin, were contraindicated due to disproportionate number of toxic deaths observed in study CA163-046.'}, {'type': 'SECONDARY', 'title': 'Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '609', 'groupId': 'OG000'}, {'value': '612', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone + Capecitabine', 'description': 'Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.'}, {'id': 'OG001', 'title': 'Capecitabine', 'description': 'Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.'}], 'classes': [{'title': 'Week 3 (n=440; n=429)', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '13.7', 'groupId': 'OG000', 'lowerLimit': '-0.96', 'upperLimit': '0.20'}, {'value': '0.0', 'spread': '4.7', 'groupId': 'OG001', 'lowerLimit': '-0.44', 'upperLimit': '0.45'}]}]}, {'title': 'Week 6 (n=379; n=353)', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '15.4', 'groupId': 'OG000', 'lowerLimit': '-1.45', 'upperLimit': '-0.31'}, {'value': '0.5', 'spread': '5.0', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '1.06'}]}]}, {'title': 'Week 9 (n=330; n=283)', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '17.4', 'groupId': 'OG000', 'lowerLimit': '-2.15', 'upperLimit': '-0.79'}, {'value': '0.7', 'spread': '5.0', 'groupId': 'OG001', 'lowerLimit': '0.06', 'upperLimit': '1.24'}]}]}, {'title': 'Week 12 (n=283; n=250)', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '17.3', 'groupId': 'OG000', 'lowerLimit': '-2.06', 'upperLimit': '-0.64'}, {'value': '1.1', 'spread': '5.2', 'groupId': 'OG001', 'lowerLimit': '0.48', 'upperLimit': '1.78'}]}]}, {'title': 'Week 15 (n=255; n=240)', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '17.0', 'groupId': 'OG000', 'lowerLimit': '-2.73', 'upperLimit': '-1.15'}, {'value': '1.5', 'spread': '5.0', 'groupId': 'OG001', 'lowerLimit': '0.90', 'upperLimit': '2.18'}]}]}, {'title': 'Week 18 (n=205; n=202)', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '15.7', 'groupId': 'OG000', 'lowerLimit': '-2.07', 'upperLimit': '-0.50'}, {'value': '1.2', 'spread': '5.4', 'groupId': 'OG001', 'lowerLimit': '0.41', 'upperLimit': '1.89'}]}]}, {'title': 'Week 21 (n=166; n=185)', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '16.8', 'groupId': 'OG000', 'lowerLimit': '-2.36', 'upperLimit': '-0.37'}, {'value': '1.7', 'spread': '5.1', 'groupId': 'OG001', 'lowerLimit': '0.97', 'upperLimit': '2.45'}]}]}, {'title': 'Week 24 (n=149; n=141)', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '17.3', 'groupId': 'OG000', 'lowerLimit': '-2.46', 'upperLimit': '-0.41'}, {'value': '1.1', 'spread': '5.4', 'groupId': 'OG001', 'lowerLimit': '0.19', 'upperLimit': '1.96'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'There was a statistically significant difference between groups in change from baseline FBSI score favoring capecitabine. A mean change from baseline of 2.5 was considered a clinically meaningful difference (minimally important difference or MID). On-treatment mean changes in the FBSI did not reach the MID in either group.', 'statisticalMethod': 'Wei-Lachin', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment', 'description': 'Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was conducted on all randomized participants on an intent to treat basis. (Note: while table only reports data up to 24 wks, which represents most results, statistical analysis includes ALL assessments through study and follow-up; a few participants were assessed after more than 100 weeks.)'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '609', 'groupId': 'OG000'}, {'value': '612', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone + Capecitabine', 'description': 'Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.'}, {'id': 'OG001', 'title': 'Capecitabine', 'description': 'Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.39', 'groupId': 'OG000', 'lowerLimit': '14.95', 'upperLimit': '17.91'}, {'value': '15.64', 'groupId': 'OG001', 'lowerLimit': '13.86', 'upperLimit': '17.02'}]}]}], 'analyses': [{'pValue': '.1162', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '.90', 'ciLowerLimit': '.78', 'ciUpperLimit': '1.03', 'pValueComment': 'The test was stratified by (taxane resistance \\[yes/no\\], measurable disease versus non-measurable disease, prior chemotherapy for metastatic disease \\[yes/no\\], and anthracycline resistance \\[yes/no\\]).', 'groupDescription': 'This primary analysis was a comparison between the 2 treatment arms using a 2-sided, α=0.05 level log-rank test (to reject the null hypothesis of equality of survival). The analysis was conducted when 880 deaths (430 in combination:450 in capecitabine) were observed from the 1221 randomized participants.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The analysis was conducted at the 0.05 level and no adjustments were performed'}, {'pValue': '.0231', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '.85', 'ciLowerLimit': '.75', 'ciUpperLimit': '.98', 'groupDescription': 'This prespecified secondary analysis was a Cox model adjusted for age, Karnofsky performance status, number of organ sites, estrogen receptor status, hepatic impairment, time from diagnosis, liver/lung metastases.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'from date of randomization until death', 'description': 'Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was conducted on all randomized patients on an intent to treat basis. This study required at least 846 events (deaths) to ensure the 2-sided, α = 0.05 level, log-rank test to have 90% power to show a statistically significant difference in OS between treatment groups when the hazard ratio (HR) is 0.8.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ixabepilone + Capecitabine', 'description': 'Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.'}, {'id': 'FG001', 'title': 'Capecitabine', 'description': 'Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '609'}, {'groupId': 'FG001', 'numSubjects': '612'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Participants who received 18 or more cycles of treatment.', 'groupId': 'FG000', 'numSubjects': '15'}, {'comment': 'Participants who received 18 or more cycles of treatment.', 'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '594'}, {'groupId': 'FG001', 'numSubjects': '597'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Disease Progression/Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '270'}, {'groupId': 'FG001', 'numSubjects': '388'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Study Drug Toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '179'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Still On Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'New primary cancer', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Impending surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'PLEASE NOTE: Completed=number of participants completing ≥18 cycles of treatment; not completed=number of subjects coming off study treatment prior to completing at least 18 cycles, with specified reasons for coming off study treatment. Participants continued to be followed for overall survival.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '609', 'groupId': 'BG000'}, {'value': '612', 'groupId': 'BG001'}, {'value': '1221', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ixabepilone + Capecitabine', 'description': 'Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.'}, {'id': 'BG001', 'title': 'Capecitabine', 'description': 'Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '532', 'groupId': 'BG000'}, {'value': '531', 'groupId': 'BG001'}, {'value': '1063', 'groupId': 'BG002'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}]}, {'title': '<50 years', 'categories': [{'measurements': [{'value': '225', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '460', 'groupId': 'BG002'}]}]}, {'title': '≥50 years', 'categories': [{'measurements': [{'value': '384', 'groupId': 'BG000'}, {'value': '377', 'groupId': 'BG001'}, {'value': '761', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.0', 'groupId': 'BG000', 'lowerLimit': '23.0', 'upperLimit': '78.0'}, {'value': '53.0', 'groupId': 'BG001', 'lowerLimit': '24.0', 'upperLimit': '81.0'}, {'value': '53.0', 'groupId': 'BG002', 'lowerLimit': '23.0', 'upperLimit': '81.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '609', 'groupId': 'BG000'}, {'value': '612', 'groupId': 'BG001'}, {'value': '1221', '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': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '480', 'groupId': 'BG000'}, {'value': '502', 'groupId': 'BG001'}, {'value': '982', 'groupId': 'BG002'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Karnofsky performance Status', 'classes': [{'title': '100', 'categories': [{'measurements': [{'value': '219', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '484', 'groupId': 'BG002'}]}]}, {'title': '90', 'categories': [{'measurements': [{'value': '187', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '375', 'groupId': 'BG002'}]}]}, {'title': '80', 'categories': [{'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '281', 'groupId': 'BG002'}]}]}, {'title': '70', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}, {'title': '<70', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'not reported', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': "Karnofsky Performance Scale Index measures a patient's functional impairment: 100-80=able to carry on normal activity and work, no special care; 70-50=unable to work; able to live at home and care for most personal needs with assistance; 40=unable to care for self; requires institutional or hospital care. Score reported in multiples of 10.", 'unitOfMeasure': 'units on a scale'}, {'title': 'Menopausal Status', 'classes': [{'title': 'Premenopausal', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}]}, {'title': 'Perimenopausal', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}, {'title': 'Postmenopausal', 'categories': [{'measurements': [{'value': '475', 'groupId': 'BG000'}, {'value': '481', 'groupId': 'BG001'}, {'value': '956', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Organ Sites', 'classes': [{'title': 'Ascites', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'Bone', 'categories': [{'measurements': [{'value': '283', 'groupId': 'BG000'}, {'value': '287', 'groupId': 'BG001'}, {'value': '570', 'groupId': 'BG002'}]}]}, {'title': 'Brain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Breast', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}, {'title': 'Chest Wall Mass', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}, {'title': 'CNS', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Cutaneous', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}, {'title': 'Effusion', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Intestine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Lymph Node', 'categories': [{'measurements': [{'value': '236', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '469', 'groupId': 'BG002'}]}]}, {'title': 'Mediastinum', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Pleura', 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}]}, {'title': 'Subcutaneous', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Visceral, Liver', 'categories': [{'measurements': [{'value': '273', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '549', 'groupId': 'BG002'}]}]}, {'title': 'Visceral, Lung', 'categories': [{'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '438', 'groupId': 'BG002'}]}]}, {'title': 'Visceral, Other', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Presence with at least 1 lesion', 'classes': [{'categories': [{'measurements': [{'value': '606', 'groupId': 'BG000'}, {'value': '612', 'groupId': 'BG001'}, {'value': '1218', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1221}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2004-05-07', 'resultsFirstSubmitDate': '2009-05-01', 'studyFirstSubmitQcDate': '2004-05-10', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-07-02', 'studyFirstPostDateStruct': {'date': '2004-05-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'from date of randomization until death', 'description': 'Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'every 6 weeks (± 3 days) from randomization while on treatment until documented progression', 'description': 'PFS was defined for each patient as the time in months from randomization to the date of progression. Patients who died without a reported prior progression were considered to have progressed on their date of death. Patients who did not progress or die were censored on the date of their last tumor assessment.'}, {'measure': 'Response Rate (RR)', 'timeFrame': 'every 6 weeks (± 3 days) from randomization while on treatment until documented progression', 'description': 'RR=number of patients in that group whose best response is "partial"(30% decrease in the sum of the longest diameter of target lesions) or "complete" (disappearance of all target lesions), according to the 4-item Response Evaluation Criteria in Solid Tumors (RECIST), divided by the total number of response-evaluable participants'}, {'measure': 'Duration of Response', 'timeFrame': 'every 6 weeks (± 3 days) from randomization while on treatment until documented progression', 'description': 'Measured from the time RECIST criteria (described in previous outcome measure) were first met for "complete" or "partial" response until first date of documented disease progression or death. Patients who neither relapsed nor died were censored on the date of last tumor assessment. Median w/ 95% CI estimated using Kaplan Meier Product Limit Method.'}, {'measure': 'Time to Response', 'timeFrame': 'every 6 weeks (± 3 days) from randomization while on treatment until documented progression', 'description': 'Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for "partial" or "complete" (whichever status was recorded first) per RECIST criteria (a 4-item scale described in the previous outcome measure).'}, {'measure': 'Treatment-Related Safety Summary', 'timeFrame': 'safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.', 'description': "Laboratory values, adverse events, and other symptoms were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTC) Version 3.0"}, {'measure': 'Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)', 'timeFrame': 'Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment', 'description': 'Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cancer', 'Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '29522361', 'type': 'DERIVED', 'citation': 'Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.'}, {'pmid': '24472478', 'type': 'DERIVED', 'citation': 'Vahdat LT, Vrdoljak E, Gomez H, Li RK, Bosserman L, Sparano JA, Baselga J, Mukhopadhyay P, Valero V. Efficacy and safety of ixabepilone plus capecitabine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer. J Geriatr Oncol. 2013 Oct;4(4):346-52. doi: 10.1016/j.jgo.2013.07.006. Epub 2013 Aug 23.'}, {'pmid': '21937232', 'type': 'DERIVED', 'citation': 'Jassem J, Fein L, Karwal M, Campone M, Peck R, Poulart V, Vahdat L. Ixabepilone plus capecitabine in advanced breast cancer patients with early relapse after adjuvant anthracyclines and taxanes: a pooled subset analysis of two phase III studies. Breast. 2012 Feb;21(1):89-94. doi: 10.1016/j.breast.2011.09.003. Epub 2011 Sep 21.'}, {'pmid': '21128114', 'type': 'DERIVED', 'citation': 'Roche H, Conte P, Perez EA, Sparano JA, Xu B, Jassem J, Peck R, Kelleher T, Hortobagyi GN. Ixabepilone plus capecitabine in metastatic breast cancer patients with reduced performance status previously treated with anthracyclines and taxanes: a pooled analysis by performance status of efficacy and safety data from 2 phase III studies. Breast Cancer Res Treat. 2011 Feb;125(3):755-65. doi: 10.1007/s10549-010-1251-y. Epub 2010 Dec 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine alone in women with metastatic breast cancer. Patients should have previously received an anthracycline and a taxane. The safety of this treatment will also be studied.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Patients must have received prior treatment which included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).\n* Patients must have received no more than two prior chemotherapy regimens. Patients who have not received treatment for metastatic disease must have relapsed within one year.\n* Patients may not have any history of brain and/or leptomeningeal metastases.\n* Patients may not have Grade 2 or worse neuropathy at the time of study entry.\n* Patients may not have had prior treatment with any epothilones and/or capecitabine (i.e. Xeloda)'}, 'identificationModule': {'nctId': 'NCT00082433', 'briefTitle': 'Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'R-Pharm'}, 'officialTitle': 'A Phase III Study of Novel Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With an Anthracycline and a Taxane', 'orgStudyIdInfo': {'id': 'CA163-048'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: Ixabepilone + Capecitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: Capecitabine']}], 'interventions': [{'name': 'Ixabepilone + Capecitabine', 'type': 'DRUG', 'otherNames': ['IXEMPRA®', 'Epothilone'], 'description': 'Ixabepilone lypholized powder/Diluent for solution for injection/Tablets, IV/Oral, 40 mg/m2 + Capecitabine 2000 mg/m2, Ixabepilone on Day 1 and Capecitabine twice daily Days 1-14 of 21 day cycle', 'armGroupLabels': ['A']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': 'Tablet, Oral, 2500 mg/m2, Capecitabine twice daily Days 1-14 of 21 day cycle', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'city': 'Corona', 'state': 'California', 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