Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-31 @ 5:33 PM
Study NCT ID:
NCT00455533
Status:
COMPLETED
Last Update Posted:
2016-02-24
First Post:
2007-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess Effectiveness of Giving Combination of Standard Chemotherapy Drugs Versus Combination of Standard Chemotherapy and New Drug Ixabepilone When Given Before Surgical Removal of Early Stage Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C430592', 'term': 'ixabepilone'}, {'id': 'D034261', 'term': 'Epothilones'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'title': 'BMS Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Adverse events are reported for randomized population.', 'eventGroups': [{'id': 'EG000', 'title': 'Ixabepilone', 'description': 'ixabepilone 40 mg/m\\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)', 'otherNumAtRisk': 145, 'otherNumAffected': 128, 'seriousNumAtRisk': 145, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Paclitaxel', 'description': 'paclitaxel 80 mg/m\\^2 administered IV every week for 12 weeks', 'otherNumAtRisk': 144, 'otherNumAffected': 117, 'seriousNumAtRisk': 144, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HOT FLUSH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 17}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DYSGEUSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PARAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'NEUROPATHY PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PERIPHERAL SENSORY NEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 44}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'STOMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ALOPECIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'NAIL DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BONE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MUCOSAL INFLAMMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'HAEMOGLOBIN DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CARDIAC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CARDIO-RESPIRATORY ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PERIPHERAL ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HYPERBILIRUBINAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ANAPHYLACTIC SHOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ANAPHYLACTIC REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SOMNOLENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ENCEPHALOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CRANIAL NEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'NEUROPATHY PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CEREBRAL VENOUS THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PERIPHERAL SENSORY NEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DEPRESSED LEVEL OF CONSCIOUSNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'GALLSTONE ILEUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HYPOALBUMINAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LEUKOCYTOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'FEBRILE NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'THROMBOTIC THROMBOCYTOPENIC PURPURA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DISSEMINATED INTRAVASCULAR COAGULATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'URTICARIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'EXFOLIATIVE RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'OVERDOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MEDICATION ERROR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LOWER LIMB FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HYPOXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PNEUMONITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'OROPHARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'NON-CARDIOGENIC PULMONARY OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ACUTE RESPIRATORY DISTRESS SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SUDDEN DEATH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Pathologic Complete Response (pCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'ixabepilone 40 mg/m\\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)'}, {'id': 'OG001', 'title': 'Paclitaxel', 'description': 'paclitaxel 80 mg/m\\^2 administered IV every week for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '24.3', 'groupId': 'OG000', 'lowerLimit': '18.6', 'upperLimit': '30.8'}, {'value': '25.2', 'groupId': 'OG001', 'lowerLimit': '19.4', 'upperLimit': '31.7'}]}]}], 'analyses': [{'pValue': '0.8921', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8966', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.96', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.55', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in pCR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-7.9', 'ciUpperLimit': '6.7', 'estimateComment': 'The difference in pCR rates and the confidence interval computed using the method of DerSimonian and Laird stratified by tumor size at baseline, estrogen receptor status, and clinical response to AC.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)', 'description': 'The pCR was defined as no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of ductal carcinoma in situ (DCIS) in the breast.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Clinical Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'ixabepilone 40 mg/m\\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)'}, {'id': 'OG001', 'title': 'Paclitaxel', 'description': 'paclitaxel 80 mg/m\\^2 administered IV every week for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '81.1', 'groupId': 'OG000', 'lowerLimit': '75.0', 'upperLimit': '86.2'}, {'value': '77.6', 'groupId': 'OG001', 'lowerLimit': '71.2', 'upperLimit': '83.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after the last dose of either ixabepilone or paclitaxel (at 12 weeks) but before surgery (4-6 weeks after the last dose of 12 weeks of therapy)', 'description': "Clinical response was defined as the number of participants who achieved modified World Health Organization's tumor response criteria of clinical complete response (complete disappearance of all clinically palpable detectable malignant disease and/or disappearance of radiological evidence of tumor in the breast and ipsilateral axillary lymph nodes) or clinical partial response (clinical evidence of a reduction in total tumor size of \\>= 50% in the overall sum of the products of diameters of breast and axillary lesions), divided by the number of randomized participants in that arm.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Requiring Breast Conservation Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'ixabepilone 40 mg/m\\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)'}, {'id': 'OG001', 'title': 'Paclitaxel', 'description': 'paclitaxel 80 mg/m\\^2 administered IV every week for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '41.9', 'groupId': 'OG000', 'lowerLimit': '35.1', 'upperLimit': '49.0'}, {'value': '32.7', 'groupId': 'OG001', 'lowerLimit': '26.3', 'upperLimit': '39.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)', 'description': 'Number of randomized participants requiring breast conservation surgery following study treatment.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Combined pCR and Minimal Residual Cancer Burden (RCB) 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'ixabepilone 40 mg/m\\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)'}, {'id': 'OG001', 'title': 'Paclitaxel', 'description': 'paclitaxel 80 mg/m\\^2 administered IV every week for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '30.4', 'groupId': 'OG000', 'lowerLimit': '24.2', 'upperLimit': '37.2'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '26.9', 'upperLimit': '40.3'}]}]}], 'analyses': [{'pValue': '0.6186', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5806', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.86', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.34', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.5', 'ciLowerLimit': '-11', 'ciUpperLimit': '6.0', 'estimateComment': 'The difference in pCR/RCB-I rates and the confidence interval computed using the method of DerSimonian and Laird stratified by tumor size at baseline, estrogen receptor status, and clinical response to AC.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)', 'description': 'Combined pCR and RCB-1 was defined as participants with no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of DCIS in the breast plus subjects with RCB-1 following the RCB calculation based on data entered by the investigator sites in each arm.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Participants'}], 'classes': [{'title': 'ABCB1 (209993_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'ABCB1 /// ABCB4 (209994_s_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'BRCA1 (211851_x_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'BRCA1 (204531_s_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'ERCC1 (203719_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'ERCC1 (203720_s_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'GTSE1 (204315_s_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'GTSE1 (204317_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'GTSE1 (215942_s_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'GTSE1 (204318_s_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'GTSE1 (211040_x_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'KLK10 (209792_s_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'KLK10 (215808_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'KLK5 (222242_s_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'KLK6 (204733_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'RRM1 (201476_s_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'RRM1 (201477_s_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TUBB (211714_x_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TUBB (212320_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TUBB (209026_x_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TUBB1 (208601_s_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TUBB2A (204141_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TUBB2A /// TUBB2B (209372_x_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TUBB2B (214023_x_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TUBB2C (208977_x_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TUBB2C (213726_x_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TUBB4 (212664_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TUBB6 (209191_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TYMS (202589_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TYMS (217684_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.4115', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'ABCB1 (209993\\_at)', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1629', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'ABCB1 209993\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.5074', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'ABCB1 209993\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.5530', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'ABCB1 /// ABCB4 209994\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1845', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'ABCB1 /// ABCB4 209994\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.3538', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'ABCB1 /// ABCB4 209994\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.9751', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'BRCA1 211851\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.8874', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'BRCA1 211851\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.6907', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'BRCA1 211851\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.8052', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'BRCA1 204531\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.5031', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'BRCA1 204531\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.7588', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'BRCA1 204531\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1542', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'ERCC1 203719\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0235', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'ERCC1 203719\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.3612', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'ERCC1 203719\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1840', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'ERCC1 203720\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0942', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'ERCC1 203720\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.5327', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'ERCC1 203720\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.8847', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'GTSE1 204315\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.8947', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'GTSE1 204315\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.4085', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'GTSE1 204315\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1119', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'GTSE1 204317\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0250', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'GTSE1 204317\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.3569', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'GTSE1 204317\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.4103', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'GTSE1 215942\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1490', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'GTSE1 215942\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.5590', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'GTSE1 215942\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.4796', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'GTSE1 204318\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2794', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'GTSE1 204318\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1646', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'GTSE1 204318\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0782', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'GTSE1 211040\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1407', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'GTSE1 211040\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2369', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER', 'groupDescription': 'GTSE1 211040\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.7756', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'KLK10 209792\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2623', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'KLK10 209792\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.3147', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'KLK10 209792\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2885', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'KLK10 215808\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.7187', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'KLK10 215808\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.6017', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'KLK10 215808\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.4500', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'KLK5 222242\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0952', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'KLK5 222242\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.7069', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'KLK5 222242\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.4767', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'KLK6 204733\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.6191', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'KLK6 204733\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.5276', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'KLK6 204733\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.3323', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'RRM1 201476\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1025', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'RRM1 201476\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1715', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'RRM1 201476\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1070', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'RRM1 201477\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2751', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment', 'groupDescription': 'RRM1 201477\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0276', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'RRM1 201477\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1689', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'TUBB 211714\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0769', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'TUBB 211714\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1058', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TUBB 211714\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.6406', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'TUBB 212320\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1733', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'TUBB 212320\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2631', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TUBB 212320\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2170', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'TUBB 209026\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0868', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'TUBB 209026\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1117', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TUBB 209026\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.4943', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'TUBB1 (208601\\_s\\_at)', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.5190', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'TUBB1 208601\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.7350', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TUBB1 208601\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.3820', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'TUBB2A 204141\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.9290', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'TUBB2A 204141\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0699', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TUBB2A 204141\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.3515', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'TUBB2A /// TUBB2B 209372\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2128', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'TUBB2A /// TUBB2B 209372\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1275', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TUBB2A /// TUBB2B 209372\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2158', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'TUBB2B 214023\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0266', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'TUBB2B 214023\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.3636', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TUBB2B 214023\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.9479', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'TUBB2C 208977\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.3753', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'TUBB2C 208977\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.5477', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TUBB2C 208977\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.4760', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'TUBB2C 213726\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.3314', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'TUBB2C 213726\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1005', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TUBB2C 213726\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1180', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'TUBB4 212664\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1580', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'TUBB4 212664\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.4385', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TUBB4 212664\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.7324', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'TUBB6 209191\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2657', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'TUBB6 209191\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.5637', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TUBB6 209191\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.4473', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'TYMS 202589\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.3292', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'TYMS 202589\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2054', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TYMS 202589\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.5226', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment: ER) and the reduced model: (PCR \\~ Treatment : ER)', 'groupDescription': 'TYMS 217684\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1720', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR \\~ Biomarker: Treatment) and the reduced model: (PCR \\~ Biomarker + Treatment)', 'groupDescription': 'TYMS 217684\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.3346', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TYMS 217684\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'pCR evaluated at time of surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.', 'description': 'Relevance of biomarker in differentiation between ixabepilone \\& paclitaxel evaluated by logistic regression with pCR as response. Statistical analyses include: 1) the likelihood ratio test between the full model (PCR\\~Biomarker:Treatment:estrogen receptor \\[ER\\]) \\& reduced model (PCR\\~Treatment:ER); 2) the likelihood ratio test between the full model (PCR\\~Biomarker:Treatment) \\& reduced model (PCR\\~Biomarker+Treatment); 3) the contrast of the interaction between treatment \\& biomarker expression within ER Negative subjects from the full model(PCR\\~Biomarker:Treatment:ER). A:B represents A,B \\& A\\*B.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Participants'}], 'classes': [{'title': 'ABCB1 (209993_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'ABCB1 /// ABCB4 (209994_s_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'BRCA1 (211851_x_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'BRCA1 (204531_s_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'ERCC1 (203719_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'ERCC1 (203720_s_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'GTSE1 (204315_s_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'GTSE1 (204317_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'GTSE1 (215942_s_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'GTSE1 (204318_s_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'GTSE1 (211040_x_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'KLK10 (209792_s_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'KLK10 (215808_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'KLK5 (222242_s_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'KLK6 (204733_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'RRM1 (201476_s_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'RRM1 (201477_s_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TUBB (211714_x_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TUBB (212320_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TUBB (209026_x_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TUBB1 (208601_s_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TUBB2A (204141_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TUBB2A /// TUBB2B (209372_x_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TUBB2B (214023_x_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TUBB2C (208977_x_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TUBB2C (213726_x_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TUBB4 (212664_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TUBB6 (209191_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TYMS (202589_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'TYMS (217684_at)', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.5604', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'ABCB1 209993\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2715', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'ABCB1 209993\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.5268', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'ABCB1 209993\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.6058', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'ABCB1 /// ABCB4 209994\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1918', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'ABCB1 /// ABCB4 209994\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.6712', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'ABCB1 /// ABCB4 209994\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.9195', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'BRCA1 211851\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.7021', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'BRCA1 211851\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.3910', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'BRCA1 211851\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2909', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'BRCA1 204531\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.3336', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'BRCA1 204531\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2360', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'BRCA1 204531\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0281', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'ERCC1 203719\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0434', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'ERCC1 203719\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0283', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'ERCC1 203719\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0151', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'ERCC1 203720\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1999', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'ERCC1 203720\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0146', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'ERCC1 203720\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1185', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'GTSE1 204315\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.8705', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'GTSE1 204315\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0284', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'GTSE1 204315\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0399', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'GTSE1 204317\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0136', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'GTSE1 204317\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0576', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'GTSE1 204317\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2245', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'GTSE1 215942\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1388', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'GTSE1 215942\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0692', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'GTSE1 215942\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1058', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'GTSE1 204318\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2688', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'GTSE1 204318\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0192', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'GTSE1 204318\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0033', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'GTSE1 211040\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2053', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'GTSE1 211040\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0032', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'GTSE1 211040\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.6783', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'KLK10 209792\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1630', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'KLK10 209792\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2944', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'KLK10 209792\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.3727', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'KLK10 215808\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.8796', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'KLK10 215808\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.8344', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'KLK10 215808\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2700', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'KLK5 222242\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2624', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'KLK5 222242\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0830', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'KLK5 222242\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0849', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'KLK6 204733\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.6578', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'KLK6 204733\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0396', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'KLK6 204733\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1657', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'RRM1 201476\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0675', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'RRM1 201476\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1071', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'RRM1 201476\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0142', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'RRM1 201477\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2465', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'RRM1 201477\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0031', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'RRM1 201477\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1231', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'TUBB 211714\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0849', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'TUBB 211714\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2740', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TUBB 211714\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2383', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'TUBB 212320\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0644', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'TUBB 212320\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2866', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TUBB 212320\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1259', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'TUBB 209026\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0718', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'TUBB 209026\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.3170', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TUBB 209026\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.7844', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'TUBB1 208601\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.4688', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'TUBB1 208601\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.8553', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TUBB1 208601\\_s\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.6926', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'TUBB2A 204141\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2222', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'TUBB2A 204141\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.4676', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TUBB2A 204141\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2036', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'TUBB2A /// TUBB2B 209372\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.4197', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'TUBB2A /// TUBB2B 209372\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0776', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TUBB2A /// TUBB2B 209372\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.4076', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'TUBB2B 214023\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0629', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'TUBB2B 214023\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2547', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TUBB2B 214023\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.7125', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'TUBB2C 208977\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.6001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'TUBB2C 208977\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.5398', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TUBB2C 208977\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.3970', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'TUBB2C 213726\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.5085', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'TUBB2C 213726\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1213', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TUBB2C 213726\\_x\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0999', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'TUBB4 212664\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1201', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'TUBB4 212664\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.1172', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TUBB4 212664\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.6596', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'TUBB6 209191\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.3289', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'TUBB6 209191\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.3657', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TUBB6 209191\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0275', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'TYMS 202589\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.3946', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'TYMS 202589\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0074', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TYMS 202589\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2341', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \\~ Treatment : ER)', 'groupDescription': 'TYMS 217684\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.0933', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \\~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \\~ Biomarker + Treatment)', 'groupDescription': 'TYMS 217684\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}, {'pValue': '0.2016', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \\~ Biomarker : Treatment : ER)', 'groupDescription': 'TYMS 217684\\_at', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value not adjusted for multiple comparison', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.', 'description': 'Relevance of biomarker in differentiation between ixabepilone \\& paclitaxel evaluated by logistic regression with pCR/RCB1 as response. Statistical analyses include: 1) likelihood ratio test between the full model (pCR/RCB1\\~Biomarker:Treatment: ER) \\& reduced model (pCR/RCB1\\~Treatment:ER); 2) likelihood ratio test between the full model (pCR/RCB1 Biomarker:Treatment) \\& reduced model (pCR/RCB1\\~Biomarker+Treatment); 3) contrast of the interaction between treatment \\& biomarker expression within ER Negative subjects from the full model (pCR/RCB1\\~Biomarker:Treatment:ER). A:B represents A,B \\& A\\*B.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-Specified Thresholds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'ixabepilone 40 mg/m\\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)'}, {'id': 'OG001', 'title': 'Paclitaxel', 'description': 'paclitaxel 80 mg/m\\^2 administered IV every week for 12 weeks'}], 'classes': [{'title': 'Mem+Cyto Threshold/Negative Biomarker Status', 'categories': [{'measurements': [{'value': '0.143', 'groupId': 'OG000', 'lowerLimit': '0.069', 'upperLimit': '0.252'}, {'value': '0.288', 'groupId': 'OG001', 'lowerLimit': '0.193', 'upperLimit': '0.4'}]}]}, {'title': 'Mem+Cyto Threshold/Positive Biomarker Status', 'categories': [{'measurements': [{'value': '0.323', 'groupId': 'OG000', 'lowerLimit': '0.225', 'upperLimit': '0.433'}, {'value': '0.259', 'groupId': 'OG001', 'lowerLimit': '0.167', 'upperLimit': '0.37'}]}]}, {'title': 'Mem Threshold/Negative Biomarker Status', 'categories': [{'measurements': [{'value': '0.228', 'groupId': 'OG000', 'lowerLimit': '0.158', 'upperLimit': '0.312'}, {'value': '0.284', 'groupId': 'OG001', 'lowerLimit': '0.211', 'upperLimit': '0.367'}]}]}, {'title': 'Mem Threshold/Negative Biomarker Status', 'categories': [{'measurements': [{'value': '0.316', 'groupId': 'OG000', 'lowerLimit': '0.147', 'upperLimit': '0.53'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0.057', 'upperLimit': '0.44'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (bootstrap method)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.145', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '-0.017', 'estimateComment': 'ixabepilone - paclitaxel', 'groupDescription': 'Mem+Cyto Threshold/Negative Biomarker Status', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (bootstrap method)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.064', 'ciLowerLimit': '-0.064', 'ciUpperLimit': '0.197', 'estimateComment': 'ixabepilone - paclitaxel', 'groupDescription': 'Mem+Cyto Threshold/Positive Biomarker STatus', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (bootstrap method)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.056', 'ciLowerLimit': '-0.152', 'ciUpperLimit': '0.046', 'estimateComment': 'ixabepilone - paclitaxel', 'groupDescription': 'Membrane Threshold/Negative Biomarker Status', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (bootstrap method)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.116', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.37', 'estimateComment': 'ixabepilone - paclitaxel', 'groupDescription': 'Membrane Threshold/Positive Biomarker Status', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': ': pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.', 'description': 'Percentage of participants with pCR in MDR1 IHC positive and negative groups using 2 pre-specified thresholds,. The first pre-specified threshold for MDR1-positivity (Mem) =Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with non-missing pCR and biomarker expression'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With pCR/RCB1 and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'ixabepilone 40 mg/m\\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)'}, {'id': 'OG001', 'title': 'Paclitaxel', 'description': 'paclitaxel 80 mg/m\\^2 administered IV every week for 12 weeks'}], 'classes': [{'title': 'Mem+Cyto Threshold/Negative Biomarker Status', 'categories': [{'measurements': [{'value': '0.224', 'groupId': 'OG000', 'lowerLimit': '0.131', 'upperLimit': '0.344'}, {'value': '0.339', 'groupId': 'OG001', 'lowerLimit': '0.237', 'upperLimit': '0.453'}]}]}, {'title': 'Mem+Cyto Threshold/Positive Biomarker Status', 'categories': [{'measurements': [{'value': '0.371', 'groupId': 'OG000', 'lowerLimit': '0.268', 'upperLimit': '0.483'}, {'value': '0.362', 'groupId': 'OG001', 'lowerLimit': '0.257', 'upperLimit': '0.478'}]}]}, {'title': 'Mem Threshold/Negative Biomarker Status', 'categories': [{'measurements': [{'value': '0.304', 'groupId': 'OG000', 'lowerLimit': '0.226', 'upperLimit': '0.393'}, {'value': '0.363', 'groupId': 'OG001', 'lowerLimit': '0.283', 'upperLimit': '0.448'}]}]}, {'title': 'Mem Threshold/Negative Biomarker Status', 'categories': [{'measurements': [{'value': '0.316', 'groupId': 'OG000', 'lowerLimit': '0.147', 'upperLimit': '0.53'}, {'value': '0.267', 'groupId': 'OG001', 'lowerLimit': '0.097', 'upperLimit': '0.511'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (bootstrap method)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.114', 'ciLowerLimit': '-0.258', 'ciUpperLimit': '0.22', 'estimateComment': 'ixabepilone - paclitaxel', 'groupDescription': 'Mem+Cyto/Negative Biomarker Status', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'DIfference (bootstrap method)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.009', 'ciLowerLimit': '-0.137', 'ciUpperLimit': '0.155', 'estimateComment': 'ixabepilone - paclitaxel', 'groupDescription': 'Mem+Cyto Threshold/Positive Biomarker Status', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (bootstrap method)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.058', 'ciLowerLimit': '-0.167', 'ciUpperLimit': '0.053', 'estimateComment': 'ixabepilone - paclitaxel', 'groupDescription': 'Membrane Threshold/Negative Biomarker Status', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (bootstrap method)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.049', 'ciLowerLimit': '-0.227', 'ciUpperLimit': '0.309', 'estimateComment': 'ixabepilone - paclitaxel', 'groupDescription': 'Membrane Threshold/Positive Biomarker Status', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.', 'description': 'Percentage of participants with pCR/RCB1 in MDR1 IHC positive and negative groups using 2 pre-specified thresholds,. The first pre-specified threshold for MDR1-positivity (Mem) =Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score .', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with non-missing pCR/RCB1 and biomarker expression'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds, Estrogen-Receptor (ER) Negative Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'ixabepilone 40 mg/m\\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)'}, {'id': 'OG001', 'title': 'Paclitaxel', 'description': 'paclitaxel 80 mg/m\\^2 administered IV every week for 12 weeks'}], 'classes': [{'title': 'Mem+Cyto Threshold/Negative Biomarker Status', 'categories': [{'measurements': [{'value': '0.192', 'groupId': 'OG000', 'lowerLimit': '0.079', 'upperLimit': '0.363'}, {'value': '0.483', 'groupId': 'OG001', 'lowerLimit': '0.32', 'upperLimit': '0.648'}]}]}, {'title': 'Mem+Cyto Threshold/Positive Biomarker Status', 'categories': [{'measurements': [{'value': '0.447', 'groupId': 'OG000', 'lowerLimit': '0.309', 'upperLimit': '0.593'}, {'value': '0.341', 'groupId': 'OG001', 'lowerLimit': '0.22', 'upperLimit': '0.481'}]}]}, {'title': 'Mem Threshold/Negative Biomarker Status', 'categories': [{'measurements': [{'value': '0.327', 'groupId': 'OG000', 'lowerLimit': '0.22', 'upperLimit': '0.449'}, {'value': '0.417', 'groupId': 'OG001', 'lowerLimit': '0.309', 'upperLimit': '0.531'}]}]}, {'title': 'Mem Threshold/Negative Biomarker Status', 'categories': [{'measurements': [{'value': '0.417', 'groupId': 'OG000', 'lowerLimit': '0.181', 'upperLimit': '0.685'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.087', 'upperLimit': '0.607'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (bootstrap method)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.29', 'ciLowerLimit': '-0.482', 'ciUpperLimit': '-0.094', 'estimateComment': 'ixabepilone - paclitaxel', 'groupDescription': 'Mem+Cyto Threshold/Negative Biomarker Status', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (boostrap method)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.106', 'ciLowerLimit': '-0.073', 'ciUpperLimit': '0.291', 'estimateComment': 'ixabepilone - paclitaxel', 'groupDescription': 'Mem+Cyto Threshold/Positive Biomarker Status', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (bootstrap method)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.09', 'ciLowerLimit': '-0.236', 'ciUpperLimit': '0.067', 'estimateComment': 'ixabepilone - paclitaxel', 'groupDescription': 'Membrane Threshold/Negative Biomarker Status', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (bootsrap method)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.117', 'ciLowerLimit': '-0.218', 'ciUpperLimit': '0.469', 'estimateComment': 'ixabepilone - paclitaxel', 'groupDescription': 'Mem+Cyto Threshold/Positive Biomarker Status', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.', 'description': 'Percentage of ER negative participants with pCR and MDR1 immunohistochemistry (IHC) positivity using 2 pre-specified thresholds, stratified by biomarker status. The first pre-specified threshold for MDR1-positivity (Mem)=Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized estrogen negative participants with non-missing pCR and biomarker expression'}, {'type': 'SECONDARY', 'title': 'Prevalence of Biomarker Based on Optimal Threshold (Biomarker Positive Participants)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Participants', 'description': 'Randomized Participants with non-missing pCR and biomarker expression'}], 'classes': [{'title': 'Beta 3 Tubulin IHC (n=231)', 'categories': [{'measurements': [{'value': '0.394', 'groupId': 'OG000', 'lowerLimit': '0.242', 'upperLimit': '0.571'}]}]}, {'title': 'Beta 3 Tubulin IHC H-Score (n=231)', 'categories': [{'measurements': [{'value': '0.299', 'groupId': 'OG000', 'lowerLimit': '0.173', 'upperLimit': '0.524'}]}]}, {'title': 'Beta 3 Tubulin mRNA (n=245)', 'categories': [{'measurements': [{'value': '0.392', 'groupId': 'OG000', 'lowerLimit': '0.167', 'upperLimit': '0.772'}]}]}, {'title': 'TACC3 mRNA (n=245)', 'categories': [{'measurements': [{'value': '0.514', 'groupId': 'OG000', 'lowerLimit': '0.273', 'upperLimit': '0.743'}]}]}, {'title': 'CAPG mRNA (n=245)', 'categories': [{'measurements': [{'value': '0.486', 'groupId': 'OG000', 'lowerLimit': '0.294', 'upperLimit': '0.767'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy and mRNA samples obtained prior to treatment', 'description': 'Percentage of participants having the following optimal biomarker thresholds as computed from the cross-validation method (cutoff of biomarker positive \\[with 90% confidence interval by Bootstrap method\\]): Beta 3 Tubulin IHC (45.866 \\[5, 83.9\\]); TACC3 mRNA (6.714 \\[6.312, 7.192\\]); CAPG mRNA (6.739 \\[5.728, 7.298\\]). Optimal thresholds for a 20-gene model and a 26-gene model were also planned; however, these were not determined because preliminary analyses did not indicate that they would not differentiate pCR rates between treatment arm.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with non-missing pCR and biomarker expressions. n=the number of participants with specific biomarker expression.'}, {'type': 'SECONDARY', 'title': 'Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'ixabepilone 40 mg/m\\^2 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'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any SAE, Grade Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'AE Leading to Discontinuation, Grade 1 (mild)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AE Leading to Discontinuation, Grade 2 (moderate)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'AE Leading to Discontinuation, Grade 3 (severe)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'AE Leading to Discon, Grade 4 (life-threatening)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Drug-Related AE, Grade 1 (mild)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Any Drug-Related AE, Grade 2 (moderate)', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Any Drug-Related AE, Grade 3 (severe)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Any Drug-Related AE, Grade 4 (life-threatening)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'TNAE: Peripheral Sensory Neuropathy,Grade 1 (mild)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'TNAE:Peripheral Sensory Neuropathy,Gr 2 (moderate)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'TNAE: Peripheral Sensory Neuropathy, Gr 3 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{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TNAE: Bone Pain, Grade 4 (life-threatening)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TNAE: Fatigue, Grade 1 (mild)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'TNAE: Fatigue, Grade 2 (moderate)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'TNAE: Fatigue, Grade 3 (severe)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'TNAE: Fatigue, Grade 4 (life-threatening)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TNAE: Diarrhea, Grade 1 (mild)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'TNAE: Diarrhea, Grade 2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'TNAE: Diarrhea, Grade 3 (severe)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'TNAE: Diarrhea, Grade 4 (life-threatening)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TNAE: Nausea, Grade 1 (mild)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'TNAE: Nausea, Grade 2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'TNAE: Nausea, Grade 3 (severe)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TNAE: Nausea, Grade 4 (life-threatening)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TNAE: Musculoskeletal Pain, Grade 1 (mild)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'TNAE: Musculoskeletal Pain, Grade 2 (moderate)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'TNAE: Musculoskeletal Pain, Grade 3 (severe)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'TNAE: Musculoskeletal Pain,Gr 4 (life-threatening)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. By Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grades', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'ixabepilone 40 mg/m\\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)'}, {'id': 'OG001', 'title': 'Paclitaxel', 'description': 'paclitaxel 80 mg/m\\^2 administered IV every week for 12 weeks'}], 'classes': [{'title': 'Any Drug-Related AEs, Grade (Gr) 1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Any Drug-Related AEs, Gr 2', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'Any Drug-Related AEs, Gr 3', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Any Drug-Related AEs, Gr 4', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Any Drug-Related AEs, Gr 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal Disorder AEs, Gr 1', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal Disorder AEs, Gr 2', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal Disorder AEs, Gr 3', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal Disorder AEs, Gr 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal Disorder AEs, Gr 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'MCT Disorder AEs, Gr 1 (spell out)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'MCT Disorder AEs, Gr 2', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'MCT Disorder AEs, Gr 3', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'MCT Disorder AEs, Gr 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'MCT Disorder AEs, Gr 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'GDASC AEs, Gr 1 (spell out)', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'GDASC AEs, Gr 2', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'GDASC AEs, Gr 3', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'GDASC AEs, Gr 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'GDASC AEs, Gr 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Skin and Subcutaneous Tissue Disorder AEs, Gr 1', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Skin and Subcutaneous Tissue Disorder AEs, Gr 2', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'Skin and Subcutaneous Tissue Disorder AEs, Gr 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Skin and Subcutaneous Tissue Disorder AEs, Gr 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Skin and Subcutaneous Tissue Disorder AEs, Gr 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nervous System Disorder AEs, Gr 1', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Nervous System Disorder AEs, Gr 2', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Nervous System Disorder AEs, Gr 3', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Nervous System Disorder AEs, Gr 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Nervous System Disorder AEs, Gr 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Blood & Lymphatic System Disorder AEs, Gr 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Blood & Lymphatic System Disorder AEs, Gr 2', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Blood & Lymphatic System Disorder AEs, Gr 3', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Blood & Lymphatic System Disorder AEs, Gr 4', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Blood & Lymphatic System Disorder AEs, Gr 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Laboratory Investigation AEs, Gr 1', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Laboratory Investigation AEs, Gr 2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Laboratory Investigation AEs, Gr 3', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Laboratory Investigation AEs, Gr 4', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Laboratory Investigation AEs, Gr 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Metabolism & Nutrition Disorder AEs, Gr 1', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Metabolism & Nutrition Disorder AEs, Gr 2', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Metabolism & Nutrition Disorder AEs, Gr 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Metabolism & Nutrition Disorder AEs, Gr 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Metabolism & Nutrition Disorder AEs, Gr 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'RTM Disorder AEs, Gr 1 (spell out)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'RTM Disorder AEs, Gr 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'RTM Disorder AEs, Gr 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'RTM Disorder AEs, Gr 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'RTM Disorder AEs, Gr 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Infections & Infestations AEs, Gr 1', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Infections & Infestations AEs, Gr 2', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Infections & Infestations AEs, Gr 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infections & Infestations AEs, Gr 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infections & Infestations, Gr 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Psychiatric Disorder AEs, Gr 1', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Psychiatric Disorder AEs, Gr 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Psychiatric Disorder AEs, Gr 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Psychiatric Disorder AEs, Gr 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Psychiatric Disorder AEs, Gr 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vascular Disorder AEs, Gr 1', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Vascular Disorder AEs, Gr 2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Vascular Disorder AEs, Gr 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vascular Disorder AEs, Gr 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Vascular Disorder AEs, Gr 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Eye Disorder AEs, Gr 1', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Eye Disorder AEs, Gr 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Eye Disorder AEs, Gr 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Eye Disorder AEs, Gr 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Eye Disorder AEs, Gr 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Immune System Disorder AEs, Gr 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Immune System Disorder AEs, Gr 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Immune System Disorder AEs, Gr 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Immune System Disorder AEs, Gr 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Immune System Disorder AEs, Gr 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Reproductive System and Breast Disorders, Gr 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Reproductive System and Breast Disorders, Gr 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Reproductive System and Breast Disorders, Gr 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Reproductive System and Breast Disorders, Gr 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Reproductive System and Breast Disorders, Gr 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac Disorder AEs, Gr 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac Disorder AEs, Gr 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac Disorder AEs, Gr 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac Disorder AEs, Gr 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac Disorder AEs, Gr 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ear and Labyrinth Disorder AEs, Gr 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Ear and Labyrinth Disorder AEs, Gr 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ear and Labyrinth Disorder AEs, Gr 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ear and Labyrinth Disorder AEs, Gr 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ear and Labyrinth Disorder AEs, Gr 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Renal and Urinary Disorder AEs, Gr 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Renal and Urinary Disorder AEs, Gr 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Renal and Urinary Disorder AEs, Gr 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Renal and Urinary Disorder AEs, Gr 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Renal and Urinary Disorder AEs, Gr 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Injury, Poisoning&Procedural Complication AEs,Gr 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Injury, Poisoning&Procedural Complication AEs,Gr 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Injury, Poisoning&Procedural Complication AEs,Gr 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Injury, Poisoning&Procedural Complication AEs,Gr 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Injury, Poisoning&Procedural Complication AEs,Gr 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hepatobiliary Disorder AEs, Gr 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hepatobiliary Disorder AEs, Gr 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hepatobiliary Disorder AEs, Gr 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hepatobiliary Disorder AEs, Gr 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hepatobiliary Disorder AEs, Gr 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NBMUCP AEs, Gr 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NBMUCP AEs, Gr 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'NBMUCP AEs, Gr 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NBMUCP AEs, Gr 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NBMUCP AEs, Gr 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy', 'description': 'MCT=musculoskeletal and connective tissue, GDASC=general disorders and administration site conditions, RTM=respiratory, thoracic and mediastinal disorders, NBMUCP=neoplasms benign, malignant and unspecified (including cysts and polyps). Drug related adverse events are those events with relationship to study therapy of certain, probable, possible or missing. Subjects may have more than one event within a class. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Ixabepilone- and Paclitaxel-treated participants'}, {'type': 'SECONDARY', 'title': 'On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'ixabepilone 40 mg/m\\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)'}, {'id': 'OG001', 'title': 'Paclitaxel', 'description': 'paclitaxel 80 mg/m\\^2 administered IV every week for 12 weeks'}], 'classes': [{'title': 'White Blood Cells (WBC), Grade 0', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'WBC, Grade 1', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'WBC, Grade 2', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'WBC, Grade 3', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'WBC, Grade 4', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'WBC, Grade 1-4', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}, {'title': 'WBC, Grade 3-4', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophil Count (ANC), Grade 0', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'ANC, Grade 1', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'ANC, Grade 2', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'ANC, Grade 3', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'ANC, Grade 4', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ANC, Grade 1-4', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'ANC, Grade 3-4', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Platelets, Grade 0', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}]}, {'title': 'Platelets, Grade 1', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Platelets, Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Platelets, Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Platelets, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Platelets, Grade 1-4', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Platelets, Grade 3-4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin, Grade 0', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin, Grade 1', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin, Grade 2', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin, Grade 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin, Grade 1-4', 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin, Grade 3-4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy during ixabepilone or paclitaxel treatment phase', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Ixabepilone/Paclitaxel treated participants for whom on-study labs were recorded.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Pathologic Complete Response (pCR) in Biomarker-Defined Populations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'ixabepilone 40 mg/m\\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)'}, {'id': 'OG001', 'title': 'Paclitaxel', 'description': 'paclitaxel 80 mg/m\\^2 administered IV every week for 12 weeks'}], 'classes': [{'title': 'Beta-III positive subgroup (cross-validation)', 'categories': [{'measurements': [{'value': '35.9', 'groupId': 'OG000', 'lowerLimit': '20.6', 'upperLimit': '53.2'}, {'value': '36.1', 'groupId': 'OG001', 'lowerLimit': '23.3', 'upperLimit': '56'}]}]}, {'title': 'Beta-III negative subgroup (cross-validation)', 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000', 'lowerLimit': '10.3', 'upperLimit': '27.1'}, {'value': '22.4', 'groupId': 'OG001', 'lowerLimit': '13.1', 'upperLimit': '32.0'}]}]}, {'title': 'Beta-III positive subgroup (n=43, 42)', 'categories': [{'measurements': [{'value': '34.9', 'groupId': 'OG000', 'lowerLimit': '22.9', 'upperLimit': '48.5'}, {'value': '35.7', 'groupId': 'OG001', 'lowerLimit': '23.5', 'upperLimit': '49.5'}]}]}, {'title': 'Beta-III negative subgroup (n=71, 75)', 'categories': [{'measurements': [{'value': '18.3', 'groupId': 'OG000', 'lowerLimit': '11.2', 'upperLimit': '27.5'}, {'value': '22.7', 'groupId': 'OG001', 'lowerLimit': '15.0', 'upperLimit': '32.0'}]}]}, {'title': 'TACC3 positive subgroup (cross-validation)', 'categories': [{'measurements': [{'value': '30.1', 'groupId': 'OG000', 'lowerLimit': '18.1', 'upperLimit': '37.9'}, {'value': '29.4', 'groupId': 'OG001', 'lowerLimit': '19.6', 'upperLimit': '47.2'}]}]}, {'title': 'TACC3 negative subgroup (cross-validation)', 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '30.7'}, {'value': '27.0', 'groupId': 'OG001', 'lowerLimit': '13.2', 'upperLimit': '41.4'}]}]}, {'title': 'CAPG positive subgroup (cross-validation)', 'categories': [{'measurements': [{'value': '30.7', 'groupId': 'OG000', 'lowerLimit': '18.9', 'upperLimit': '47.4'}, {'value': '35.3', 'groupId': 'OG001', 'lowerLimit': '24.0', 'upperLimit': '49.9'}]}]}, {'title': 'CAPG negative subgroup (cross-validation)', 'categories': [{'measurements': [{'value': '20.4', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': '31.5'}, {'value': '20.7', 'groupId': 'OG001', 'lowerLimit': '9.1', 'upperLimit': '44.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.', 'description': 'Beta III tubulin positivity determined by cross-validation method. Optimal cutoff: ≥46% tumor cells staining at 2 plus or 3 plus intensity (corresponding Beta III tubulin positivity=39.4%). Pre-specified cutoff of Beta III tubulin positivity: ≥50% 2plus or 3plus cells (corresponding prevalence=38.5%). Optimal cutoffs for TACC3 and CAPG positivity determined by cross-validation method: 6.889 and 6.844 \\[log2 normalized intensity units\\], respectively (corresponding to prevalence rates of 43.3% and 44.3%).', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For all subgroups other than Beta-III positive/negative subgroup based on a pre-determined cutoff, results were estimated using a cross-validation method (a resampling based technique, making individual sample size \\[N\\] not applicable).'}, {'type': 'SECONDARY', 'title': 'On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'ixabepilone 40 mg/m\\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)'}, {'id': 'OG001', 'title': 'Paclitaxel', 'description': 'paclitaxel 80 mg/m\\^2 administered IV every week for 12 weeks'}], 'classes': [{'title': 'ALT, Grade 0 (n=142, 140)', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'ALT, Grade 1 (n=142, 140)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'ALT, Grade 2 (n=142, 140)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'ALT, Grade 3 (n=142, 140)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'ALT, Grade 4 (n=142, 140)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT, Grade 1-4 (n=142, 140)', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}, {'title': 'ALT, Grade 3-4 (n=142, 140)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'AST, Grade 0 (n=141, 140)', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'AST, Grade 1 (n=141, 140)', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'AST, Grade 2 (n=141, 140)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'AST, Grade 3 (n=141, 140)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'AST, Grade 4 (n=141, 140)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AST, Grade 1-4 (n=141, 140)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'AST, Grade 3-4 (n=141, 140)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase, Grade 0 (n=141, 140)', 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase, Grade 1 (n=141, 140)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase, Grade 2 (n=141, 140)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase, Grade 3 (n=141, 140)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase, Grade 4 (n=141, 140)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase, Grade 1-4 (n=141, 140)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase, Grade 3-4 (n=141, 140)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin, Grade 0 (n=142, 140)', 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin, Grade 1 (n=142, 140)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin, Grade 2 (n=142, 140)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin, Grade 3 (n=142, 140)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin, Grade 4 (n=142, 140)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin, Grade 1-4 (n=142, 140)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin, Grade 3-4 (n=142, 140)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of study therapy during ixabepilone or paclitaxel treatment phase', 'description': 'Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST). AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Ixabepilone/Paclitaxel treated participants for whom on-study labs were recorded; n=number of participants with specific laboratory evaluation.'}, {'type': 'SECONDARY', 'title': 'On-Study Renal Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'ixabepilone 40 mg/m\\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)'}, {'id': 'OG001', 'title': 'Paclitaxel', 'description': 'paclitaxel 80 mg/m\\^2 administered IV every week for 12 weeks'}], 'classes': [{'title': 'Creatinine, Grade 0', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, Grade 1', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, Grade 1-4', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, Grade 3-4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy during ixabepilone or paclitaxel treatment phase', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Ixabepilone/Paclitaxel treated participants for whom on-study labs were recorded.'}, {'type': 'SECONDARY', 'title': 'Number of Participants by Dose for AC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'ixabepilone 40 mg/m\\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)'}, {'id': 'OG001', 'title': 'Paclitaxel', 'description': 'paclitaxel 80 mg/m\\^2 administered IV every week for 12 weeks'}], 'classes': [{'title': 'Dose 1 (Week 3)', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}, {'title': 'Dose 2 (Week 6)', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}, {'title': 'Dose 3 (Week 9)', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}]}, {'title': 'Dose 4 (Week 12)', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks (4 3-week cycles)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ixabepilone- and paclitaxel-treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants by Dose for Ixabepilone/Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'ixabepilone 40 mg/m\\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)'}, {'id': 'OG001', 'title': 'Paclitaxel', 'description': 'paclitaxel 80 mg/m\\^2 administered IV every week for 12 weeks'}], 'classes': [{'title': 'Dose 1 (Week 3, ixabepilone; Week 1 paclitaxel)', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}, {'title': 'Dose 2 (Week 6, ixabepilone; Week 2 paclitaxel)', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}]}, {'title': 'Dose 3 (Week 9, ixabepilone; Week 3 paclitaxel)', 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}]}, {'title': 'Dose 4 (Week 12, ixabepilone; Week 4 paclitaxel)', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}]}, {'title': 'Dose 5 (Week 5 paclitaxel)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}]}, {'title': 'Dose 6 (Week 6 paclitaxel)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}]}, {'title': 'Dose 7 (Week 7 paclitaxel)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}]}, {'title': 'Dose 8 (Week 8 paclitaxel)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}]}, {'title': 'Dose 9 (Week 9 paclitaxel)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}]}, {'title': 'Dose 10 (Week 10 paclitaxel)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}, {'title': 'Dose 11 (Week 11 paclitaxel)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}]}, {'title': 'Dose 12 (Week 12 paclitaxel)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ixabepilone- and paclitaxel-treated participants'}, {'type': 'SECONDARY', 'title': 'Reason for First Dose Reduction of AC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'ixabepilone 40 mg/m\\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)'}, {'id': 'OG001', 'title': 'Paclitaxel', 'description': 'paclitaxel 80 mg/m\\^2 administered IV every week for 12 weeks'}], 'classes': [{'title': 'Participants with at least 1 dose reduction of AC', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Adverse Event', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hematologic Toxicity', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Non-Hematologic Toxicity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks (4 3-week cycles)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ixabepilone- and paclitaxel-treated participants with at least 2 courses of AC'}, {'type': 'SECONDARY', 'title': 'Reason for First Dose Reduction of Ixabepilone/Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'ixabepilone 40 mg/m\\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)'}, {'id': 'OG001', 'title': 'Paclitaxel', 'description': 'paclitaxel 80 mg/m\\^2 administered IV every week for 12 weeks'}], 'classes': [{'title': 'Participants with at least 1 dose reduction', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Adverse Event', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hematologic Toxicity', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Non-Hematologic Toxicity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Peripheral Neuropathy', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ixabepilone- and paclitaxel-treated participants with at least 2 courses of Ixabepilone/Paclitaxel'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Course Delay and Reason for Delay for AC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'ixabepilone 40 mg/m\\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)'}, {'id': 'OG001', 'title': 'Paclitaxel', 'description': 'paclitaxel 80 mg/m\\^2 administered IV every week for 12 weeks'}], 'classes': [{'title': 'Participants with at least 1 dose delay', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Administrative Reason', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Adverse Event', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Hematologic Toxicity', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Non-Hematologic Toxicity', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Subject Request', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks (4 3-week cycles)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ixabepilone- and paclitaxel-treated participants with at least 2 courses of AC'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Dose Delay and Reason for Dose Delay for Ixabepilone/Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'ixabepilone 40 mg/m\\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)'}, {'id': 'OG001', 'title': 'Paclitaxel', 'description': 'paclitaxel 80 mg/m\\^2 administered IV every week for 12 weeks'}], 'classes': [{'title': 'Participants with at least 1 dose delay', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Administrative Reason', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Adverse Event', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Hematologic Toxicity', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Non-Hematologic Toxicity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Peripheral Neuropathy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Subject Request', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ixabepilone- and paclitaxel-treated participants with at least 2 courses of Ixabepilone/Paclitaxel'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Pathologic Complete Response (pCR) in 20- and 26-Gene Model Subgroups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone', 'description': 'ixabepilone 40 mg/m\\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)'}, {'id': 'OG001', 'title': 'Paclitaxel', 'description': 'paclitaxel 80 mg/m\\^2 administered IV every week for 12 weeks'}], 'timeFrame': 'pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.', 'description': 'For each of the 2 biomarker sets (20-gene or 26-gene), a multi-gene model was built using penalized logistic regression on all pharmacogenomic evaluable subjects for each treatment arm separately. Receiver Operating Characteristic (ROC) plots for separate arm using 5 fold cross validation were generated. ROC for separate arms using cross over were also added. Further analysis on the multiple gene models (as mentioned in the SAP) was planned only based on the initial findings from the 2 ROC plots. For 20- and 26-gene models, ROC curves generated for each study arm did not indicate that these multi-gene models differentially predicted for pCR between the treatment arms, so further analyses to estimate the optimal cut-off and the pCR rates were not conducted.', 'reportingStatus': 'POSTED', 'populationDescription': 'For 20- and 26-gene models, ROC curves generated for each study arm did not indicate that these multi-gene models differentially predicted for pCR between the treatment arms, so further analyses to estimate the optimal cut-off and the pCR rates were not conducted.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Doxorubicin / Cyclophosphamide (AC)', 'description': '60 mg/m\\^2 doxorubicin and 600 mg/m\\^2 cyclophosphamide (AC) every 3 weeks for 4 cycles (12 weeks).'}, {'id': 'FG001', 'title': 'Ixabepilone', 'description': 'ixabepilone 40 mg/m\\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)'}, {'id': 'FG002', 'title': 'Paclitaxel', 'description': 'Paclitaxel 80 mg/m\\^2 administered IV every week for 12 weeks'}], 'periods': [{'title': 'Period One: Initial Chemotherapy', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '313'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '295'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event Not Related to Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Not Reported', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other--Need Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Study Drug Toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Subject Request to Discontinue Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Subject No Longer Meets Study Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Subject Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Period Two: Randomized Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': '148 randomized, 145 randomized and treated with ixabepilone', 'groupId': 'FG001', 'numSubjects': '145'}, {'comment': '147 randomized, 144 randomized and treated with paclitaxel', 'groupId': 'FG002', 'numSubjects': '144'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '139'}, {'groupId': 'FG002', 'numSubjects': '138'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other - need reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Study Drug Toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Subject Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 384 participants were enrolled in this study; 71 did not receive any study medication.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ixabepilone (Randomized Population)', 'description': 'ixabepilone 40 mg/m\\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)'}, {'id': 'BG001', 'title': 'Paclitaxel (Randomized Population)', 'description': 'paclitaxel 80 mg/m\\^2 administered IV every week for 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.0', 'groupId': 'BG000', 'lowerLimit': '25.0', 'upperLimit': '79.0'}, {'value': '46.0', 'groupId': 'BG001', 'lowerLimit': '26.0', 'upperLimit': '74.0'}, {'value': '48.0', 'groupId': 'BG002', 'lowerLimit': '25.0', 'upperLimit': '79.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '271', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': '<50 years', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}]}, {'title': '>=50 years', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '295', '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': 'White', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Asian Indian', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'Chinese', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Asian Other', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Karnofsky Performance Status-Baseline', 'classes': [{'title': '100 - Normal no complaints; no evidence of disease', 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}]}, {'title': '90 - Normal activity; minor signs of disease', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': '80 - Activity with effort; some signs of disease', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': '70 - Unable to carry on normal activity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '<=60 Needs increasing assistance up to Death (0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Classifies patients according to their functional impairment. Scores range from 0-100, the lower the score, the worse the survival for most serious illnesses.', 'unitOfMeasure': 'participants'}, {'title': 'Menopausal Status', 'classes': [{'title': 'Pre-Menopausal', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}, {'title': 'Peri-Menopausal', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Post-Menopausal', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', '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': 384}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-25', 'studyFirstSubmitDate': '2007-04-02', 'resultsFirstSubmitDate': '2011-03-04', 'studyFirstSubmitQcDate': '2007-04-02', 'lastUpdatePostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-04', 'studyFirstPostDateStruct': {'date': '2007-04-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Pathologic Complete Response (pCR)', 'timeFrame': 'at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)', 'description': 'The pCR was defined as no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of ductal carcinoma in situ (DCIS) in the breast.'}, {'measure': 'Percentage of Participants Achieving Pathologic Complete Response (pCR) in Biomarker-Defined Populations', 'timeFrame': 'pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.', 'description': 'Beta III tubulin positivity determined by cross-validation method. Optimal cutoff: ≥46% tumor cells staining at 2 plus or 3 plus intensity (corresponding Beta III tubulin positivity=39.4%). Pre-specified cutoff of Beta III tubulin positivity: ≥50% 2plus or 3plus cells (corresponding prevalence=38.5%). Optimal cutoffs for TACC3 and CAPG positivity determined by cross-validation method: 6.889 and 6.844 \\[log2 normalized intensity units\\], respectively (corresponding to prevalence rates of 43.3% and 44.3%).'}, {'measure': 'Percentage of Participants Achieving Pathologic Complete Response (pCR) in 20- and 26-Gene Model Subgroups', 'timeFrame': 'pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.', 'description': 'For each of the 2 biomarker sets (20-gene or 26-gene), a multi-gene model was built using penalized logistic regression on all pharmacogenomic evaluable subjects for each treatment arm separately. Receiver Operating Characteristic (ROC) plots for separate arm using 5 fold cross validation were generated. ROC for separate arms using cross over were also added. Further analysis on the multiple gene models (as mentioned in the SAP) was planned only based on the initial findings from the 2 ROC plots. For 20- and 26-gene models, ROC curves generated for each study arm did not indicate that these multi-gene models differentially predicted for pCR between the treatment arms, so further analyses to estimate the optimal cut-off and the pCR rates were not conducted.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Clinical Objective Response', 'timeFrame': 'after the last dose of either ixabepilone or paclitaxel (at 12 weeks) but before surgery (4-6 weeks after the last dose of 12 weeks of therapy)', 'description': "Clinical response was defined as the number of participants who achieved modified World Health Organization's tumor response criteria of clinical complete response (complete disappearance of all clinically palpable detectable malignant disease and/or disappearance of radiological evidence of tumor in the breast and ipsilateral axillary lymph nodes) or clinical partial response (clinical evidence of a reduction in total tumor size of \\>= 50% in the overall sum of the products of diameters of breast and axillary lesions), divided by the number of randomized participants in that arm."}, {'measure': 'Percentage of Participants Requiring Breast Conservation Surgery', 'timeFrame': 'at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)', 'description': 'Number of randomized participants requiring breast conservation surgery following study treatment.'}, {'measure': 'Percentage of Participants Achieving Combined pCR and Minimal Residual Cancer Burden (RCB) 1', 'timeFrame': 'at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)', 'description': 'Combined pCR and RCB-1 was defined as participants with no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of DCIS in the breast plus subjects with RCB-1 following the RCB calculation based on data entered by the investigator sites in each arm.'}, {'measure': 'Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR', 'timeFrame': 'pCR evaluated at time of surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.', 'description': 'Relevance of biomarker in differentiation between ixabepilone \\& paclitaxel evaluated by logistic regression with pCR as response. Statistical analyses include: 1) the likelihood ratio test between the full model (PCR\\~Biomarker:Treatment:estrogen receptor \\[ER\\]) \\& reduced model (PCR\\~Treatment:ER); 2) the likelihood ratio test between the full model (PCR\\~Biomarker:Treatment) \\& reduced model (PCR\\~Biomarker+Treatment); 3) the contrast of the interaction between treatment \\& biomarker expression within ER Negative subjects from the full model(PCR\\~Biomarker:Treatment:ER). A:B represents A,B \\& A\\*B.'}, {'measure': 'Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1', 'timeFrame': 'pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.', 'description': 'Relevance of biomarker in differentiation between ixabepilone \\& paclitaxel evaluated by logistic regression with pCR/RCB1 as response. Statistical analyses include: 1) likelihood ratio test between the full model (pCR/RCB1\\~Biomarker:Treatment: ER) \\& reduced model (pCR/RCB1\\~Treatment:ER); 2) likelihood ratio test between the full model (pCR/RCB1 Biomarker:Treatment) \\& reduced model (pCR/RCB1\\~Biomarker+Treatment); 3) contrast of the interaction between treatment \\& biomarker expression within ER Negative subjects from the full model (pCR/RCB1\\~Biomarker:Treatment:ER). A:B represents A,B \\& A\\*B.'}, {'measure': 'Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-Specified Thresholds', 'timeFrame': ': pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.', 'description': 'Percentage of participants with pCR in MDR1 IHC positive and negative groups using 2 pre-specified thresholds,. The first pre-specified threshold for MDR1-positivity (Mem) =Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score.'}, {'measure': 'Percentage of Participants With pCR/RCB1 and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds', 'timeFrame': 'pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.', 'description': 'Percentage of participants with pCR/RCB1 in MDR1 IHC positive and negative groups using 2 pre-specified thresholds,. The first pre-specified threshold for MDR1-positivity (Mem) =Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score .'}, {'measure': 'Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds, Estrogen-Receptor (ER) Negative Participants', 'timeFrame': 'pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.', 'description': 'Percentage of ER negative participants with pCR and MDR1 immunohistochemistry (IHC) positivity using 2 pre-specified thresholds, stratified by biomarker status. The first pre-specified threshold for MDR1-positivity (Mem)=Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score.'}, {'measure': 'Prevalence of Biomarker Based on Optimal Threshold (Biomarker Positive Participants)', 'timeFrame': 'pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy and mRNA samples obtained prior to treatment', 'description': 'Percentage of participants having the following optimal biomarker thresholds as computed from the cross-validation method (cutoff of biomarker positive \\[with 90% confidence interval by Bootstrap method\\]): Beta 3 Tubulin IHC (45.866 \\[5, 83.9\\]); TACC3 mRNA (6.714 \\[6.312, 7.192\\]); CAPG mRNA (6.739 \\[5.728, 7.298\\]). Optimal thresholds for a 20-gene model and a 26-gene model were also planned; however, these were not determined because preliminary analyses did not indicate that they would not differentiate pCR rates between treatment arm.'}, {'measure': 'Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants', 'timeFrame': 'prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. By Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grades'}, {'measure': 'Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class', 'timeFrame': 'prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy', 'description': 'MCT=musculoskeletal and connective tissue, GDASC=general disorders and administration site conditions, RTM=respiratory, thoracic and mediastinal disorders, NBMUCP=neoplasms benign, malignant and unspecified (including cysts and polyps). Drug related adverse events are those events with relationship to study therapy of certain, probable, possible or missing. Subjects may have more than one event within a class. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)'}, {'measure': 'On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase', 'timeFrame': 'prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy during ixabepilone or paclitaxel treatment phase', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)'}, {'measure': 'On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase', 'timeFrame': 'prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of study therapy during ixabepilone or paclitaxel treatment phase', 'description': 'Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST). AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)'}, {'measure': 'On-Study Renal Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase', 'timeFrame': 'prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy during ixabepilone or paclitaxel treatment phase', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)'}, {'measure': 'Number of Participants by Dose for AC', 'timeFrame': '12 weeks (4 3-week cycles)'}, {'measure': 'Number of Participants by Dose for Ixabepilone/Paclitaxel', 'timeFrame': '12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)'}, {'measure': 'Reason for First Dose Reduction of AC', 'timeFrame': '12 weeks (4 3-week cycles)'}, {'measure': 'Reason for First Dose Reduction of Ixabepilone/Paclitaxel', 'timeFrame': '12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)'}, {'measure': 'Number of Participants With Course Delay and Reason for Delay for AC', 'timeFrame': '12 weeks (4 3-week cycles)'}, {'measure': 'Number of Participants With Dose Delay and Reason for Dose Delay for Ixabepilone/Paclitaxel', 'timeFrame': '12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Early Breast Cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '27312051', 'type': 'DERIVED', 'citation': 'Abdel-Fatah TMA, Agarwal D, Liu DX, Russell R, Rueda OM, Liu K, Xu B, Moseley PM, Green AR, Pockley AG, Rees RC, Caldas C, Ellis IO, Ball GR, Chan SYT. SPAG5 as a prognostic biomarker and chemotherapy sensitivity predictor in breast cancer: a retrospective, integrated genomic, transcriptomic, and protein analysis. Lancet Oncol. 2016 Jul;17(7):1004-1018. doi: 10.1016/S1470-2045(16)00174-1. Epub 2016 Jun 14.'}], 'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The study will evaluate the effectiveness of ixabepilone when given after doxorubicin plus cyclophosphamide (AC) compared to standard treatment of paclitaxel given after doxorubicin plus cyclophosphamide in patients with early stage breast cancer. In addition the study will verify predefined biomarkers as well as discover new biomarkers that could identify patients who are more likely to respond to ixabepilone than standard paclitaxel based therapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Histologically confirmed primary invasive adenocarcinoma of the breast , T2-3, N0-3, M0, with tumor size of ≥ 2 cm\n* All patients with early stage breast adenocarcinoma may enroll irrespective of receptor status\n* No prior treatment for breast cancer excluding therapy for DCIS\n* Karnofsky performance status of 80 - 100\n* left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or multiple gated acquisition (MUGA)\n* Adequate hematologic, hepatic and renal function\n\nExclusion Criteria\n\n* women of child-bearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy during and up to 8 weeks after the last dose of the investigational drug\n* Women who are pregnant or breastfeeding\n* Inflammatory or metastatic breast cancer\n* Unfit for breast and/or axillary surgery\n* Evidence of baseline sensory or motor neuropathy\n* Significant history of cardiovascular disease, serious intercurrent illness or infections including known human immu immunodeficiency virus (HIV) infection\n* History of prior anthracycline therapy Allergies to any study medication or Cremophor® EL'}, 'identificationModule': {'nctId': 'NCT00455533', 'briefTitle': 'Study to Assess Effectiveness of Giving Combination of Standard Chemotherapy Drugs Versus Combination of Standard Chemotherapy and New Drug Ixabepilone When Given Before Surgical Removal of Early Stage Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Randomized Phase II Biomarker Neoadjuvant Study of Sequential AC Followed by Ixabepilone Compared to 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