Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:23 PM
Study NCT ID:
NCT00373256
Status:
COMPLETED
Last Update Posted:
2012-09-10
First Post:
2006-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico']}, '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': 'D000077210', 'term': 'Sunitinib'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Sunitinib + Paclitaxel', 'description': 'Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m\\^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m\\^2 based on tolerability; re-escalation to 80 or 90 mg/m\\^2 upon recovery was permitted.', 'otherNumAtRisk': 235, 'otherNumAffected': 232, 'seriousNumAtRisk': 235, 'seriousNumAffected': 89}, {'id': 'EG001', 'title': 'Bevacizumab + Paclitaxel', 'description': 'Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m\\^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m\\^2 based on tolerability; re-escalation to 80 or 90 mg/m\\^2 upon recovery was permitted.', 'otherNumAtRisk': 242, 'otherNumAffected': 239, 'seriousNumAtRisk': 242, 'seriousNumAffected': 85}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 104}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 65}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 55}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 170}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 98}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 92}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 145}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 109}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 118}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 113}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 58}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 148}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 156}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 52}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 45}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 43}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 30}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 62}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 30}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 27}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 64}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 39}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 26}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 23}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 42}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 54}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 51}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 53}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 67}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 116}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 32}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 23}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 23}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 48}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 72}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 63}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 100}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 32}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 116}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 142}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dry 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nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Iron deficiency', 'stats': 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'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Axillary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Joint effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Joint stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Osteonecrosis of jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Osteopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hair colour changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Heat rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hidradenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 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obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Device related sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Metastases to meninges', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arterial rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Supraventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Wound necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib + Paclitaxel', 'description': 'Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m\\^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m\\^2 based on tolerability; re-escalation to 80 or 90 mg/m\\^2 upon recovery was permitted.'}, {'id': 'OG001', 'title': 'Bevacizumab + Paclitaxel', 'description': 'Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m\\^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m\\^2 based on tolerability; re-escalation to 80 or 90 mg/m\\^2 upon recovery was permitted.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '8.5'}, {'value': '9.2', 'groupId': 'OG001', 'lowerLimit': '7.7', 'upperLimit': '13.0'}]}]}], 'analyses': [{'pValue': '0.9986', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6299', 'ciLowerLimit': '1.1793', 'ciUpperLimit': '2.2527', 'pValueComment': 'p-value from 1-sided log-rank stratified for prior adjuvant chemotherapy, hormone receptor status, disease-free interval from prior adjuvant treatment. Stratification factors from Interactive Voice Randomization System.', 'estimateComment': 'Assuming proportional hazards, a hazard ratio greater than 1 indicated a reduction in hazard rate in favor Bevacizumab + Paclitaxel.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death', 'description': 'Time from date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS = (first event date minus randomization date +1) divided by 30.4', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all patients who were randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib + Paclitaxel', 'description': 'Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m\\^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m\\^2 based on tolerability; re-escalation to 80 or 90 mg/m\\^2 upon recovery was permitted.'}, {'id': 'OG001', 'title': 'Bevacizumab + Paclitaxel', 'description': 'Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m\\^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m\\^2 based on tolerability; re-escalation to 80 or 90 mg/m\\^2 upon recovery was permitted.'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Objective Response Rate (ORR) (percent)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.2', 'ciLowerLimit': '26.4', 'ciUpperLimit': '38.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Objective Response Rate (ORR) (percent)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.1', 'ciLowerLimit': '26.3', 'ciUpperLimit': '38.4', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months', 'description': 'Objective response = participants with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions. A PR was defined as a \\> = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib + Paclitaxel', 'description': 'Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m\\^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m\\^2 based on tolerability; re-escalation to 80 or 90 mg/m\\^2 upon recovery was permitted.'}, {'id': 'OG001', 'title': 'Bevacizumab + Paclitaxel', 'description': 'Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m\\^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m\\^2 based on tolerability; re-escalation to 80 or 90 mg/m\\^2 upon recovery was permitted.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '7.9'}, {'value': '14.8', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '21.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death due to any cause', 'description': 'DR=time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to first documentation of objective disease progression or death due to any cause, whichever was first. DR was calculated as \\[the date response ended (ie, date of progressive disease or death) minus first CR or PR date that was subsequently confirmed +1)\\] divided by 30.4.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. DR was calculated for the subgroup of subjects with objective response. 78 subjects reported CR or PR response and were analyzed for DR in each treatment group.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib + Paclitaxel', 'description': 'Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m\\^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m\\^2 based on tolerability; re-escalation to 80 or 90 mg/m\\^2 upon recovery was permitted.'}, {'id': 'OG001', 'title': 'Bevacizumab + Paclitaxel', 'description': 'Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m\\^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m\\^2 based on tolerability; re-escalation to 80 or 90 mg/m\\^2 upon recovery was permitted.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'comment': 'The upper confidence interval was not reached.', 'groupId': 'OG000', 'lowerLimit': '16.4', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median OS for bevacizumab + paclitaxel at the time of data cut off was not reached; therefore, it could not be calculated.', 'groupId': 'OG001', 'lowerLimit': '22.1', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization up to 5 years. Survival follow-up changed to 28-days after treatment discontinuation when study was discontinued.', 'description': 'OS was defined as the time from date of randomization to death due to any cause. OS (in months) was calculated as (date of death minus randomization date +1) divided by 30.4.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. The median OS for bevacizumab + paclitaxel at the time of data cut off was not reached; therefore, it could not be calculated.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Surviving at 1 and 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib + Paclitaxel', 'description': 'Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m\\^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m\\^2 based on tolerability; re-escalation to 80 or 90 mg/m\\^2 upon recovery was permitted.'}, {'id': 'OG001', 'title': 'Bevacizumab + Paclitaxel', 'description': 'Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m\\^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m\\^2 based on tolerability; re-escalation to 80 or 90 mg/m\\^2 upon recovery was permitted.'}], 'classes': [{'title': 'Year 1', 'categories': [{'measurements': [{'value': '76.8', 'groupId': 'OG000'}, {'value': '83.7', 'groupId': 'OG001'}]}]}, {'title': 'Year 2', 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000'}, {'value': '61.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '76.8', 'ciLowerLimit': '68.7', 'ciUpperLimit': '83.0', 'groupDescription': '1 year', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.5', 'ciLowerLimit': '20.9', 'ciUpperLimit': '50.3', 'groupDescription': '2 years', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '83.7', 'ciLowerLimit': '76.0', 'ciUpperLimit': '89.1', 'groupDescription': '1 year', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '61.0', 'ciLowerLimit': '43.2', 'ciUpperLimit': '74.7', 'groupDescription': '2 years', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Year 1, Year 2', 'description': 'Percentage of those surviving at the end of one year or end of 2 years from the first dose of study treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT.'}, {'type': 'SECONDARY', 'title': 'European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib + Paclitaxel', 'description': 'Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m\\^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m\\^2 based on tolerability; re-escalation to 80 or 90 mg/m\\^2 upon recovery was permitted.'}, {'id': 'OG001', 'title': 'Bevacizumab + Paclitaxel', 'description': 'Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m\\^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m\\^2 based on tolerability; re-escalation to 80 or 90 mg/m\\^2 upon recovery was permitted.'}], 'timeFrame': 'Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months', 'description': 'EORTC QLQ-C30: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. EORTC QLQ-C30 evaluations were not analyzed since enrollment in this study was terminated early for futility.'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ Breast Cancer Module (BR23)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib + Paclitaxel', 'description': 'Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m\\^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m\\^2 based on tolerability; re-escalation to 80 or 90 mg/m\\^2 upon recovery was permitted.'}, {'id': 'OG001', 'title': 'Bevacizumab + Paclitaxel', 'description': 'Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m\\^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m\\^2 based on tolerability; re-escalation to 80 or 90 mg/m\\^2 upon recovery was permitted.'}], 'timeFrame': 'Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months', 'description': 'BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. BR23 evaluations were not analyzed since enrollment in this study was terminated early for futility at the first interim analysis.'}, {'type': 'SECONDARY', 'title': 'Euro Quality of Life-5 Dimension (EQ-5D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib + Paclitaxel', 'description': 'Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m\\^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m\\^2 based on tolerability; re-escalation to 80 or 90 mg/m\\^2 upon recovery was permitted.'}, {'id': 'OG001', 'title': 'Bevacizumab + Paclitaxel', 'description': 'Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m\\^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m\\^2 based on tolerability; re-escalation to 80 or 90 mg/m\\^2 upon recovery was permitted.'}], 'timeFrame': 'Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months', 'description': 'EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities). Three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A single score between 1 and 3 is generated for each domain. For each subject, the outcome rating on the 5 domains could be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the subject.', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. EQ-5D evaluations were not analyzed since enrollment in this study was terminated early for futility at the first interim analysis.'}, {'type': 'SECONDARY', 'title': 'EQ - Visual Analog Scale (EQ-VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib + Paclitaxel', 'description': 'Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m\\^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m\\^2 based on tolerability; re-escalation to 80 or 90 mg/m\\^2 upon recovery was permitted.'}, {'id': 'OG001', 'title': 'Bevacizumab + Paclitaxel', 'description': 'Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m\\^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m\\^2 based on tolerability; re-escalation to 80 or 90 mg/m\\^2 upon recovery was permitted.'}], 'timeFrame': 'Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months', 'description': 'EQ-VAS score on the self-rated "thermometer," indicating the patient\'s own assessment of their health status from 0 (worst) to 100 (best) imaginable health state.', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. EQ-VAS evaluations were not analyzed since enrollment in this study was terminated early for futility at the first interim analysis.'}, {'type': 'SECONDARY', 'title': 'Biomarkers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib + Paclitaxel', 'description': 'Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m\\^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m\\^2 based on tolerability; re-escalation to 80 or 90 mg/m\\^2 upon recovery was permitted.'}, {'id': 'OG001', 'title': 'Bevacizumab + Paclitaxel', 'description': 'Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m\\^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m\\^2 based on tolerability; re-escalation to 80 or 90 mg/m\\^2 upon recovery was permitted.'}], 'timeFrame': 'Day 1 of Cycles 1 through 3 and 5, Day 8 of Cycle 1, and Day 15 of Cycle 1', 'description': 'Concentrations of plasma proteins (eg, soluble Vascular Endothelial Growth Factor Receptor 2 \\[VEGFR2\\] and VEGFR3, VEGF-A, placental growth factor \\[PlGF\\], soluble KIT, and possibly soluble PDGFRĪ² and PDGF) that may be associated with angiogenesis and tumor proliferation.', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Biomarker data were collected, but since the study was stopped early and there were too few events of OS, PFS, etc, data were not analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sunitinib + Paclitaxel', 'description': 'Starting sunitinib doses of 25 milligrams (mg) daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 milligrams per square meter (mg/m\\^2), at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m\\^2 based on tolerability; re-escalation to 80 or 90 mg/m\\^2 upon recovery was permitted.'}, {'id': 'FG001', 'title': 'Bevacizumab + Paclitaxel', 'description': 'Bevacizumab 10 milligrams per kilogram (mg/kg); infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m\\^2, as a 1 hour infusion. 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PFS = (first event date minus randomization date +1) divided by 30.4'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Objective Response', 'timeFrame': 'From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months', 'description': 'Objective response = participants with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions. A PR was defined as a \\> = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.'}, {'measure': 'Duration of Response (DR)', 'timeFrame': 'From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death due to any cause', 'description': 'DR=time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to first documentation of objective disease progression or death due to any cause, whichever was first. DR was calculated as \\[the date response ended (ie, date of progressive disease or death) minus first CR or PR date that was subsequently confirmed +1)\\] divided by 30.4.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From date of randomization up to 5 years. Survival follow-up changed to 28-days after treatment discontinuation when study was discontinued.', 'description': 'OS was defined as the time from date of randomization to death due to any cause. OS (in months) was calculated as (date of death minus randomization date +1) divided by 30.4.'}, {'measure': 'Percentage of Participants Surviving at 1 and 2 Years', 'timeFrame': 'Year 1, Year 2', 'description': 'Percentage of those surviving at the end of one year or end of 2 years from the first dose of study treatment.'}, {'measure': 'European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)', 'timeFrame': 'Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months', 'description': 'EORTC QLQ-C30: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.'}, {'measure': 'EORTC QLQ Breast Cancer Module (BR23)', 'timeFrame': 'Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months', 'description': 'BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.'}, {'measure': 'Euro Quality of Life-5 Dimension (EQ-5D)', 'timeFrame': 'Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months', 'description': 'EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities). Three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A single score between 1 and 3 is generated for each domain. For each subject, the outcome rating on the 5 domains could be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the subject.'}, {'measure': 'EQ - Visual Analog Scale (EQ-VAS)', 'timeFrame': 'Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months', 'description': 'EQ-VAS score on the self-rated "thermometer," indicating the patient\'s own assessment of their health status from 0 (worst) to 100 (best) imaginable health state.'}, {'measure': 'Biomarkers', 'timeFrame': 'Day 1 of Cycles 1 through 3 and 5, Day 8 of Cycle 1, and Day 15 of Cycle 1', 'description': 'Concentrations of plasma proteins (eg, soluble Vascular Endothelial Growth Factor Receptor 2 \\[VEGFR2\\] and VEGFR3, VEGF-A, placental growth factor \\[PlGF\\], soluble KIT, and possibly soluble PDGFRĪ² and PDGF) that may be associated with angiogenesis and tumor proliferation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast cancer', 'advanced', 'sunitinib', 'bevacizumab', 'paclitaxel', 'Phase 3'], 'conditions': ['Breast Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181094&StudyName=A%20Study%20Of%20SU011248%20Plus%20Paclitaxel%20Versus%20Bevacizumab%20Plus%20Paclitaxel%20In%20Patients%20With%20Advanced%20Breast%20Cancer', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer', 'detailedDescription': 'On May 27, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of Study A6181094. The DMC determined Study A6181094 had met pre-specified futility criteria and was unlikely to meet its primary endpoint to demonstrate a statistically significant improvement in progression-free survival (PFS) in patients treated with sunitinib plus paclitaxel versus bevacizumab plus paclitaxel. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings. Enrollment in this study has been stopped.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of advanced breast cancer.\n* Measurable disease as per RECIST (Response Evaluation Criterion) in Solid Tumors or bone-only disease.\n* ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.\n\nExclusion Criteria:\n\n* No prior treatment with cytotoxics in the advanced disease setting.\n* HER2/neu positive disease unless trastuzumab was previously received or is contraindicated.\n* Treatment with a taxane in the adjuvant setting unless disease free interval \\>12 months after end of treatment.'}, 'identificationModule': {'nctId': 'NCT00373256', 'briefTitle': 'A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 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