Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-01 @ 11:23 PM
Study NCT ID:
NCT00723957
Status:
COMPLETED
Last Update Posted:
2020-10-28
First Post:
2008-07-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Advanced Nonsmall-Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C430592', 'term': 'ixabepilone'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'C089957', 'term': 'BMS 181339'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D019540', 'term': 'Area Under Curve'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D013223', 'term': 'Statistics as Topic'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D010599', 'term': 'Pharmacokinetics'}, {'id': 'D008660', 'term': 'Metabolism'}, {'id': 'D002620', 'term': 'Pharmacological and Toxicological Phenomena'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, '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': 'Ixabepilone, 32 mg/m^2 + Carboplatin (AUC)', 'description': 'Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles', 'otherNumAtRisk': 95, 'otherNumAffected': 88, 'seriousNumAtRisk': 95, 'seriousNumAffected': 27}, {'id': 'EG001', 'title': 'Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)', 'description': 'Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles', 'otherNumAtRisk': 96, 'otherNumAffected': 91, 'seriousNumAtRisk': 96, 'seriousNumAffected': 28}], 'otherEvents': [{'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HYPERSENSITIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 6}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DYSGEUSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PARAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'NEUROPATHY PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PERIPHERAL SENSORY NEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 27}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 22}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ALOPECIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 55}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 25}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HAEMOPTYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'BLOOD CREATININE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ATRIAL FLUTTER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CARDIAC ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CARDIAC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'SINUS TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PERICARDIAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'VENTRICULAR FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PERICARDITIS CONSTRICTIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PHLEBITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CIRCULATORY COLLAPSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ANAPHYLACTIC REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'MYELITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CONVULSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CEREBRAL ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CAROTID ARTERY STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'SPINAL CORD COMPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PERIPHERAL SENSORY NEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DYSPHAGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PEPTIC ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'LOWER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'RENAL FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HYPOMAGNESAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'FEBRILE NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'FEMUR FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'SPINAL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HAEMOPTYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PNEUMONITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'BRONCHIAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'OESOPHAGOBRONCHIAL FISTULA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'MULTI-ORGAN FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'GENERAL PHYSICAL HEALTH DETERIORATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'SARCOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'LUNG NEOPLASM MALIGNANT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'NON-SMALL CELL LUNG CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'METASTASES TO CENTRAL NERVOUS SYSTEM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival in the Subgroup of Participants With βIII-tubulin Positive Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)', 'description': 'Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles'}, {'id': 'OG001', 'title': 'Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)', 'description': 'Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '4.27', 'spread': 'NA', 'groupId': 'OG000', 'lowerLimit': '2.89', 'upperLimit': '5.65'}, {'value': '4.27', 'spread': 'NA', 'groupId': 'OG001', 'lowerLimit': '3.61', 'upperLimit': '6.05'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '90', 'paramValue': '1.04', 'ciUpperLimit': '1.41', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.5735', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'P-value is 1-sided', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to disease progression or death (maximum reached: 14.39 months )', 'description': 'Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on-study tumor assessment, progression-free survival was censored at the date of randomization. A tumor was considered to be beta III (βIII)-tubulin positive if 50% or more of the tumor cells had a βIII-tubulin immunohistochemistry staining intensity equal to or greater than that of the positive control.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with βIII-tubulin positive tumors and who received study drug'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival in the Subgroup of Participants With βIII-tubulin Negative Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)', 'description': 'Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles'}, {'id': 'OG001', 'title': 'Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)', 'description': 'Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '5.78', 'spread': 'NA', 'groupId': 'OG000', 'lowerLimit': '5.29', 'upperLimit': '8.41'}, {'value': '5.32', 'spread': 'NA', 'groupId': 'OG001', 'lowerLimit': '4.27', 'upperLimit': '5.98'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '90', 'paramValue': '0.78', 'ciUpperLimit': '1.10', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1750', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'P-value is 1-sided', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to disease progression or death (maximum reached: 12.29 months)', 'description': 'Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on study tumor assessment, progression-free survival was censored at the date of randomization.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had βIII-tubulin positive tumors and who received study drug'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival in the Overall Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)', 'description': 'Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles'}, {'id': 'OG001', 'title': 'Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)', 'description': 'Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '5.29', 'groupId': 'OG000', 'lowerLimit': '4.14', 'upperLimit': '5.88'}, {'value': '5.13', 'groupId': 'OG001', 'lowerLimit': '4.21', 'upperLimit': '5.78'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '90', 'paramValue': '0.92', 'ciUpperLimit': '1.15', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.316', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'ONE_SIDED', 'groupDescription': 'P-value is 1-sided', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to disease progression or death, assessed to 12.29 months', 'description': 'Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on study tumor assessment, progression-free survival was censored at the date of randomization.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received study drug'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)', 'description': 'Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles'}, {'id': 'OG001', 'title': 'Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)', 'description': 'Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles'}], 'classes': [{'title': 'βIII-tubulin positive subgroup (n=53, n=51)', 'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '29.80'}, {'value': '29.4', 'groupId': 'OG001', 'lowerLimit': '17.5', 'upperLimit': '43.8'}]}]}, {'title': 'βIII-tubulin negative subgroup (n=45, n=48)', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000', 'lowerLimit': '14.6', 'upperLimit': '41.9'}, {'value': '27.1', 'groupId': 'OG001', 'lowerLimit': '15.3', 'upperLimit': '41.8'}]}]}, {'title': 'Overall population', 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '13.8', 'upperLimit': '30.9'}, {'value': '28.3', 'groupId': 'OG001', 'lowerLimit': '19.7', 'upperLimit': '38.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At randomization and then every 6 weeks to date of CR, PR, or progression for 6 21-day cycles', 'description': 'Response evaluated per Response Evaluaton in Solid Tumor (V1.0) guidelines and assessed using magnetic resonance imaging. Percentage of best response=the total number of participants with the best overall response of CR or PR divided by the total number of randomized participants in that treatment arm. CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)', 'description': 'Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles'}, {'id': 'OG001', 'title': 'Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)', 'description': 'Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles'}], 'classes': [{'title': 'Beta III positive (n=9, 15)', 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '19.3'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '18.1'}]}]}, {'title': 'Beta III negative (n=12, 13)', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '17.4'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '5.1', 'upperLimit': '12.9'}]}]}, {'title': 'Overall population', 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '19.3'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '5.1', 'upperLimit': '18.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to date of first response (PR or CR)', 'description': 'Time to Response is defined as the time from randomization date until the date of first response (Partial Response \\[PR\\] or Complete Response \\[CR\\])', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Death as Outcome, Drug-related Adverse Events (AEs), Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation, and Drug-related Peripheral Neuropathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)', 'description': 'Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles'}, {'id': 'OG001', 'title': 'Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)', 'description': 'Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles'}], 'classes': [{'title': 'Death', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Drug-related AEs', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Drug-related SAEs', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'AEs Leading to Discontinuation', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Drug-related peripheral neuropathy', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 through 21, continuously', 'description': 'An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as possibly, probably, or certainly related to and of unknown relationship to study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received any investigational product.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hematology Laboratory Results of Grade 3 or 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)', 'description': 'Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles'}, {'id': 'OG001', 'title': 'Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)', 'description': 'Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles'}], 'classes': [{'title': 'Leukopenia, Grade 3 or 4', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Neutropenia, Grade 3 or 4', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Thrombocytopenia, Grade 3 or 4', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Anemia, Grade 3 or 4', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At screening and weekly during 21-day cycle', 'description': 'LLN=lower level of normal. Leukocytes (leukopenia) Grade 1: \\<LLN to 3.0\\*10\\^9/L, Grade 2:\\<3.0 to 2.0\\*10\\^9/L, Grade 3: \\<2.0 to 1.0\\*10\\^9/L, Grade 4: \\<1.0\\*10\\^9/L; Neutrophils (neutropenia) Grade 1: \\<LLN to 1.5\\*10\\^9/L, Grade 2: \\<1.5 to 1.0\\*10\\^9/L, Grade 3: \\<1.0 to 0.5\\*10\\^9/L, Grade 4: \\<0.5\\*10\\^9/L; Platelet count(thrombocytopenia) Grade 1: LLN to 75.0\\*10\\^9/L, Grade 2: \\<75.0 to 50.0\\*10\\^9/L, Grade 3: \\<50.0 to 25.0\\*10\\^9/L, Grade 4:\\<25.0 to 10\\^9/L; Hemoglobin (anemia) Grade 1: \\<LLN to 10.0 g/dL, Grade 2: \\<10.0 to 8.0 g/dL, Grade 3: \\<8.0 to 6.5 g/dL, Grade 4: \\<6.5 g/dL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received any investigational product.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Grade 3 or 4 Abnormalities in Liver Function and Urine Laboratory Test Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)', 'description': 'Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles'}, {'id': 'OG001', 'title': 'Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)', 'description': 'Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles'}], 'classes': [{'title': 'ALP, Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALP. Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AST, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'AST, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At screening and within 72 hours of start of 21-day cycle (Cycle 2 and beyond)', 'description': 'ULN=upper level of normal. Alkaline phosphatase (ALP) Gr 1:\\>ULN to 2.5\\*ULN, Gr 2: \\>2.5 to 5.0\\*ULN, Gr 3: \\>5.0 to 20.0\\*ULN, Gr 4: \\>20.0\\*ULN; Aspartate aminotransferase (AST) Gr 1: \\>ULN to 2.5\\*ULN, Gr 2: \\>2.5 to 5.0\\*ULN, Gr 3: \\>5.0 to 20.0\\*ULN, Gr 4: \\>20.0\\*ULN', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received any investigational product.'}, {'type': 'SECONDARY', 'title': 'Median Length of Survival in the Overall Population and in the Subgroups of Patients With βIII-tubulin Positive (β3T+) and βIII-tubulin Negative (β3T-)Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)', 'description': 'Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles'}, {'id': 'OG001', 'title': 'Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)', 'description': 'Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles'}], 'classes': [{'title': 'βIII-tubulin positive subgroup (n=53, 51)', 'categories': [{'measurements': [{'value': '10.61', 'spread': 'NA', 'groupId': 'OG000', 'lowerLimit': '7.16', 'upperLimit': '13.96'}, {'value': '11.37', 'spread': 'NA', 'groupId': 'OG001', 'lowerLimit': '8.15', 'upperLimit': '15.41'}]}]}, {'title': 'βIII-tubulin negative subgroup (n=45, 48)', 'categories': [{'measurements': [{'value': '16.92', 'spread': 'NA', 'groupId': 'OG000', 'lowerLimit': '13.04', 'upperLimit': '27.96'}, {'value': '9.40', 'spread': 'NA', 'groupId': 'OG001', 'lowerLimit': '7.98', 'upperLimit': '13.40'}]}]}, {'title': 'Overall population', 'categories': [{'measurements': [{'value': '13.04', 'spread': 'NA', 'groupId': 'OG000', 'lowerLimit': '9.99', 'upperLimit': '14.52'}, {'value': '10.15', 'spread': 'NA', 'groupId': 'OG001', 'lowerLimit': '8.28', 'upperLimit': '13.40'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '90', 'paramValue': '1.6', 'ciUpperLimit': '2.10', 'estimateComment': 'β3T+ subgroup', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '90', 'paramValue': '0.70', 'ciUpperLimit': '0.90', 'estimateComment': 'β3T- subgroup', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '90', 'paramValue': '1.10', 'ciUpperLimit': '1.40', 'estimateComment': 'Overall population', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to death or last known alive date, up to 31.34 months', 'description': 'Overall Survival was computed for all randomized participants and was defined as the time between randomization and death. Participants who did not die at the end of the study were censored at their last known alive date.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized to receive treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)', 'description': 'Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles'}, {'id': 'FG001', 'title': 'Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)', 'description': 'Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomized', 'groupId': 'FG000', 'numSubjects': '98'}, {'comment': 'Randomized', 'groupId': 'FG001', 'numSubjects': '99'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed 6 cycles of study drug (maximum per protocol)', 'groupId': 'FG000', 'numSubjects': '47'}, {'comment': 'Completed 6 cycles of study drug (maximum per protocol)', 'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '53'}]}], 'dropWithdraws': [{'type': 'Adverse event unrelated to study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Maximum clinical benefit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Investigator decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Study drug toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Reason not analyzed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Never received treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'Of 260 participants enrolled, 197 were randomized. Among those randomized, 191 received treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)', 'description': 'Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles'}, {'id': 'BG001', 'title': 'Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)', 'description': 'Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Beta III (βIII)-tubulin positive tumors (n=53, 51)', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'BG000', 'lowerLimit': '29.0', 'upperLimit': '80.0'}, {'value': '60.0', 'groupId': 'BG001', 'lowerLimit': '43.0', 'upperLimit': '80.0'}, {'value': '60.0', 'groupId': 'BG002', 'lowerLimit': '29.0', 'upperLimit': '80.0'}]}]}, {'title': 'βIII-tubulin negative tumors (N=45, 48)', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'BG000', 'lowerLimit': '35.0', 'upperLimit': '78.0'}, {'value': '60.5', 'groupId': 'BG001', 'lowerLimit': '34.0', 'upperLimit': '85.0'}, {'value': '60.0', 'groupId': 'BG002', 'lowerLimit': '34.0', 'upperLimit': '85.0'}]}]}], 'paramType': 'MEDIAN', 'description': 'Participants with beta III (βIII)-tubulin positive tumors', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of participants with βIII-tubulin positive and negative tumors', 'classes': [{'title': 'βIII tubulin-positive tumors', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}, {'title': 'βIII tubulin-negative tumors', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2008-07-25', 'resultsFirstSubmitDate': '2011-06-20', 'studyFirstSubmitQcDate': '2008-07-25', 'lastUpdatePostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-09-08', 'studyFirstPostDateStruct': {'date': '2008-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival in the Subgroup of Participants With βIII-tubulin Positive Tumors', 'timeFrame': 'Randomization to disease progression or death (maximum reached: 14.39 months )', 'description': 'Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on-study tumor assessment, progression-free survival was censored at the date of randomization. A tumor was considered to be beta III (βIII)-tubulin positive if 50% or more of the tumor cells had a βIII-tubulin immunohistochemistry staining intensity equal to or greater than that of the positive control.'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival in the Subgroup of Participants With βIII-tubulin Negative Tumors', 'timeFrame': 'Randomization to disease progression or death (maximum reached: 12.29 months)', 'description': 'Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on study tumor assessment, progression-free survival was censored at the date of randomization.'}, {'measure': 'Progression-free Survival in the Overall Population', 'timeFrame': 'Randomization to disease progression or death, assessed to 12.29 months', 'description': 'Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on study tumor assessment, progression-free survival was censored at the date of randomization.'}, {'measure': 'Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR)', 'timeFrame': 'At randomization and then every 6 weeks to date of CR, PR, or progression for 6 21-day cycles', 'description': 'Response evaluated per Response Evaluaton in Solid Tumor (V1.0) guidelines and assessed using magnetic resonance imaging. Percentage of best response=the total number of participants with the best overall response of CR or PR divided by the total number of randomized participants in that treatment arm. CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.'}, {'measure': 'Time to Response', 'timeFrame': 'Randomization to date of first response (PR or CR)', 'description': 'Time to Response is defined as the time from randomization date until the date of first response (Partial Response \\[PR\\] or Complete Response \\[CR\\])'}, {'measure': 'Number of Participants With Death as Outcome, Drug-related Adverse Events (AEs), Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation, and Drug-related Peripheral Neuropathy', 'timeFrame': 'Days 1 through 21, continuously', 'description': 'An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as possibly, probably, or certainly related to and of unknown relationship to study treatment.'}, {'measure': 'Number of Participants With Hematology Laboratory Results of Grade 3 or 4', 'timeFrame': 'At screening and weekly during 21-day cycle', 'description': 'LLN=lower level of normal. Leukocytes (leukopenia) Grade 1: \\<LLN to 3.0\\*10\\^9/L, Grade 2:\\<3.0 to 2.0\\*10\\^9/L, Grade 3: \\<2.0 to 1.0\\*10\\^9/L, Grade 4: \\<1.0\\*10\\^9/L; Neutrophils (neutropenia) Grade 1: \\<LLN to 1.5\\*10\\^9/L, Grade 2: \\<1.5 to 1.0\\*10\\^9/L, Grade 3: \\<1.0 to 0.5\\*10\\^9/L, Grade 4: \\<0.5\\*10\\^9/L; Platelet count(thrombocytopenia) Grade 1: LLN to 75.0\\*10\\^9/L, Grade 2: \\<75.0 to 50.0\\*10\\^9/L, Grade 3: \\<50.0 to 25.0\\*10\\^9/L, Grade 4:\\<25.0 to 10\\^9/L; Hemoglobin (anemia) Grade 1: \\<LLN to 10.0 g/dL, Grade 2: \\<10.0 to 8.0 g/dL, Grade 3: \\<8.0 to 6.5 g/dL, Grade 4: \\<6.5 g/dL.'}, {'measure': 'Number of Participants With Grade 3 or 4 Abnormalities in Liver Function and Urine Laboratory Test Results', 'timeFrame': 'At screening and within 72 hours of start of 21-day cycle (Cycle 2 and beyond)', 'description': 'ULN=upper level of normal. Alkaline phosphatase (ALP) Gr 1:\\>ULN to 2.5\\*ULN, Gr 2: \\>2.5 to 5.0\\*ULN, Gr 3: \\>5.0 to 20.0\\*ULN, Gr 4: \\>20.0\\*ULN; Aspartate aminotransferase (AST) Gr 1: \\>ULN to 2.5\\*ULN, Gr 2: \\>2.5 to 5.0\\*ULN, Gr 3: \\>5.0 to 20.0\\*ULN, Gr 4: \\>20.0\\*ULN'}, {'measure': 'Median Length of Survival in the Overall Population and in the Subgroups of Patients With βIII-tubulin Positive (β3T+) and βIII-tubulin Negative (β3T-)Tumors', 'timeFrame': 'Randomization to death or last known alive date, up to 31.34 months', 'description': 'Overall Survival was computed for all randomized participants and was defined as the time between randomization and death. Participants who did not die at the end of the study were censored at their last known alive date.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Advanced/Metastatic Non-Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '23589560', 'type': 'DERIVED', 'citation': 'Edelman MJ, Schneider CP, Tsai CM, Kim HT, Quoix E, Luft AV, Kaleta R, Mukhopadhyay P, Trifan OC, Whitaker L, Reck M. Randomized phase II study of ixabepilone or paclitaxel plus carboplatin in patients with non-small-cell lung cancer prospectively stratified by beta-3 tubulin status. J Clin Oncol. 2013 Jun 1;31(16):1990-6. doi: 10.1200/JCO.2012.45.3282. Epub 2013 Apr 15.'}], 'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether progression-free survival with ixabepilone is superior to that achieved with paclitaxel plus carboplatin in participants with advanced nonsmall-cell lung cancer and beta III (βIII)-tubulin-positive tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed non-small cell lung cancer (NSCLC)(squamous cell, adenocarcinoma, large cell, or bronchoalveolar carcinoma)\n* Stage IIIB NSCLC with pleural effusion, Stage IV NSCLC, or recurrent disease following surgery with or without radiation therapy\n* Available paraffin-embedded tissue to measure the expression levels of βIII tubulin\n* Disease measurable by Response Evaluation Criteria in Solid Tumors, with at least 1 target lesion situated outside any previous radiotherapy field\n* Karnofsky performance status of 70-100\n* Life expectancy of at least 3 months\n* Men and women, ages 18 years and older\n\nExclusion Criteria:\n\n* Uncontrolled brain metastases\n* Peripheral neuropathy greater than Grade 1\n* Fewer than 4 weeks from prior radiation therapy or locoregional surgeries to randomization date (less than 1 week from focal/palliative radiotherapy or minor surgery)\n* Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix\n* Known HIV-positive status\n* Absolute neutrophil count lower than 1500 cells mm\\^3\n* Total bilirubin level higher than upper limit of normal (ULN) as defined by the institution (with the exception of elevation due to Gilbert's syndrome)\n* Aspartate transaminase or alanine transaminase level higher than 2.5\\*ULN\n* Serum creatine level of 1.5 mg/dL or higher\n* Renal function with a creatinine clearance of less than 50 mL/min (as calculated with the Cockcroft and Gault equation)\n* Any prior antineoplastic systemic regimens."}, 'identificationModule': {'nctId': 'NCT00723957', 'briefTitle': 'A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Advanced Nonsmall-Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'R-Pharm'}, 'officialTitle': 'A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'CA163-163'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)', 'interventionNames': ['Drug: Ixabepilone, 32 mg/m^2', 'Drug: Carboplatin (area under the concentration curve [AUC] 6)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)', 'interventionNames': ['Drug: Paclitaxel, 200 mg/m^2', 'Drug: Carboplatin (area under the concentration curve [AUC] 6)']}], 'interventions': [{'name': 'Ixabepilone, 32 mg/m^2', 'type': 'DRUG', 'otherNames': ['IXEMPRA', 'BMS-247550'], 'description': 'Intravenous (IV) solutions, ixabepilone, 32 mg/m\\^2', 'armGroupLabels': ['Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)']}, {'name': 'Paclitaxel, 200 mg/m^2', 'type': 'DRUG', 'otherNames': ['TAXOL', 'BMS-181339', 'PARAPLATIN', 'BMY-26575'], 'description': 'IV solutions, paclitaxel, 200 mg/m\\^2', 'armGroupLabels': ['Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)']}, {'name': 'Carboplatin (area under the concentration curve [AUC] 6)', 'type': 'DRUG', 'description': 'Carboplatin (AUC 6) day 1, every 21 days, 6 cycles', 'armGroupLabels': ['Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)', 'Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90237', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 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