Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT00077857
Status:
COMPLETED
Last Update Posted:
2013-05-10
First Post:
2004-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic 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': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffman-LaRoche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Safety Population included all randomized participants who received study drug. Note: 14 patients randomized to the 1250 mg/m\\^2 arm actual received an initial dose that ranged from 480 to 984 mg/m\\^2 so were included in the 825 mg/m\\^2 arm for safety.', 'eventGroups': [{'id': 'EG000', 'title': '1250 mg/m^2 Capecitabine + Docetaxel', 'description': '1250 mg/m\\^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m\\^2 intravenous on day 1 of each 3 week cycle.', 'otherNumAtRisk': 217, 'otherNumAffected': 192, 'seriousNumAtRisk': 217, 'seriousNumAffected': 41}, {'id': 'EG001', 'title': '825 mg/m^2 Capecitabine + Docetaxel', 'description': '825 mg/m\\^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m\\^2 intravenous on day 1 of each 3 week cycle.', 'otherNumAtRisk': 248, 'otherNumAffected': 223, 'seriousNumAtRisk': 248, 'seriousNumAffected': 53}], 'otherEvents': [{'term': 'Stomatitis all', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 88}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 81}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 58}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 45}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Palmar-Plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 104}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 82}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 38}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 50}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 70}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 36}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 31}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 10}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Stomatitis all', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Gastrointestinal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Lung infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Chest wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Labyrinthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Nail infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Neutropenic sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Malignant pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Brain herniation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Thoracic vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cholangitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Palmar-Plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Quadriparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Acute psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Progression of Disease or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1250 mg/m^2 Capecitabine + Docetaxel', 'description': '1250 mg/m\\^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m\\^2 intravenous on day 1 of each 3 week cycle.'}, {'id': 'OG001', 'title': '825 mg/m^2 Capecitabine + Docetaxel', 'description': '825 mg/m\\^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m\\^2 intravenous on day 1 of each 3 week cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '8.5'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '7.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Event driven (after 350 events). Median observation time was approximately 16 months.', 'description': 'Progression Free Survival was defined as the time from the date of randomization to the day of documented disease progression or death due to any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population included all participants who received at least one dose of study and who did not have any major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Best Overall Response Being Complete Response (CR) or Partial Response (PR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1250 mg/m^2 Capecitabine + Docetaxel', 'description': '1250 mg/m\\^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m\\^2 intravenous on day 1 of each 3 week cycle.'}, {'id': 'OG001', 'title': '825 mg/m^2 Capecitabine + Docetaxel', 'description': '825 mg/m\\^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m\\^2 intravenous on day 1 of each 3 week cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.1', 'groupId': 'OG000', 'lowerLimit': '38.6', 'upperLimit': '51.7'}, {'value': '37.4', 'groupId': 'OG001', 'lowerLimit': '31.2', 'upperLimit': '44.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until Progressive Disease (PD) or end of primary study treatment (up to 16 cycles) plus 28 days.', 'description': 'According to Response Evaluation Criteria in Solid Tumors (RECIST) criteria: CR is defined as the disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the nadir sum LD.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Time to Overall Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1250 mg/m^2 Capecitabine + Docetaxel', 'description': '1250 mg/m\\^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m\\^2 intravenous on day 1 of each 3 week cycle.'}, {'id': 'OG001', 'title': '825 mg/m^2 Capecitabine + Docetaxel', 'description': '825 mg/m\\^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m\\^2 intravenous on day 1 of each 3 week cycle.'}], 'classes': [{'title': 'Week 1-6', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Week 7-12', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Week 13-18', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Week 19-24', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 25-30', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 31-36', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 43-48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until PD or end of primary study treatment (up to 16 cycles) plus 28 days.', 'description': 'For patients with Best Overall Response being Complete Response (CR) or Partial Response (PR), time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR were met. The percentage of participants with overall response within the given time ranges in each of the categories: Weeks 1-6, 7-12, 13-18, 19-24, 25-30, 31-36, and 43-48 are reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Duration of Overall Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1250 mg/m^2 Capecitabine + Docetaxel', 'description': '1250 mg/m\\^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m\\^2 intravenous on day 1 of each 3 week cycle.'}, {'id': 'OG001', 'title': '825 mg/m^2 Capecitabine + Docetaxel', 'description': '825 mg/m\\^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m\\^2 intravenous on day 1 of each 3 week cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '8.6'}, {'value': '6.9', 'groupId': 'OG001', 'lowerLimit': '5.8', 'upperLimit': '9.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Until PD or death. Median duration of response was approximately 7 months.', 'description': 'Duration of overall response was measured from the time that measurement criteria were first met for Complete Response or Partial Response until the first date that progressive disease or death was documented.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1250 mg/m^2 Capecitabine + Docetaxel', 'description': '1250 mg/m\\^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m\\^2 intravenous on day 1 of each 3 week cycle.'}, {'id': 'OG001', 'title': '825 mg/m^2 Capecitabine + Docetaxel', 'description': '825 mg/m\\^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m\\^2 intravenous on day 1 of each 3 week cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '5.8'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '5.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Until premature withdrawal or end of primary study treatment (up to 16 cycles).', 'description': 'The time to treatment failure was the time from the date of randomization to the first occurrence of any of the following events:\n\n* adverse events\n* insufficient therapeutic response (disease progression)\n* death\n* failure to return\n* refusing treatment/being unwilling to cooperate\n* withdrawing consent.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all randomized participants who received study drug. Note: 14 patients randomized to 1250 mg/m\\^2 actual received an initial dose that ranged from 480 to 984 mg/m\\^2 so are included in the 825 mg/m\\^2 arm for safety.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1250 mg/m^2 Capecitabine + Docetaxel', 'description': '1250 mg/m\\^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m\\^2 intravenous on day 1 of each 3 week cycle.'}, {'id': 'OG001', 'title': '825 mg/m^2 Capecitabine + Docetaxel', 'description': '825 mg/m\\^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m\\^2 intravenous on day 1 of each 3 week cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000', 'lowerLimit': '13.6', 'upperLimit': '21.8'}, {'value': '15.1', 'groupId': 'OG001', 'lowerLimit': '12.9', 'upperLimit': '17.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Throughout the study. Median observation time was approximately 16 months.', 'description': 'Overall Survival was measured as the time from the date of randomization to the date of death.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events and Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1250 mg/m^2 Capecitabine + Docetaxel', 'description': '1250 mg/m\\^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m\\^2 intravenous on day 1 of each 3 week cycle.'}, {'id': 'OG001', 'title': '825 mg/m^2 Capecitabine + Docetaxel', 'description': '825 mg/m\\^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m\\^2 intravenous on day 1 of each 3 week cycle.'}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '206', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First study drug intake until last study drug intake plus 28 days', 'description': 'An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.\n\nA serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is Life-Threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.\n\nAdditional information about Adverse Events can be found in the Adverse Event Section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all randomized participants who received study drug. Note: 14 patients randomized to 1250 mg/m\\^2 actual received an initial dose that ranged from 480 to 984 mg/m\\^2 so are included in the 825 mg/m\\^2 arm for safety.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1250 mg/m^2 Capecitabine + Docetaxel', 'description': '1250 mg/m\\^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m\\^2 intravenous on day 1 of each 3 week cycle.'}, {'id': 'FG001', 'title': '825 mg/m^2 Capecitabine + Docetaxel', 'description': '825 mg/m\\^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m\\^2 intravenous on day 1 of each 3 week cycle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '235'}, {'groupId': 'FG001', 'numSubjects': '235'}]}, {'type': 'Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '231'}, {'groupId': 'FG001', 'numSubjects': '234'}]}, {'type': 'Safety Population: Actual Dose Received', 'achievements': [{'comment': '14 patients in the 1250 dose arm received a lower dose and were included in the 825 arm for Safety.', 'groupId': 'FG000', 'numSubjects': '217'}, {'groupId': 'FG001', 'numSubjects': '248'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}, {'groupId': 'FG001', 'numSubjects': '204'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Insufficient therapeutic response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '128'}]}, {'type': 'Violation of selection criteria at entry', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other protocol violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Refused treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Failure to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '470', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '1250 mg/m^2 Capecitabine + Docetaxel', 'description': '1250 mg/m\\^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m\\^2 intravenous on day 1 of each 3 week cycle.'}, {'id': 'BG001', 'title': '825 mg/m^2 Capecitabine + Docetaxel', 'description': '825 mg/m\\^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m\\^2 intravenous on day 1 of each 3 week cycle.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.9', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '75'}, {'value': '50.6', 'groupId': 'BG001', 'lowerLimit': '28', 'upperLimit': '75'}, {'value': '50.75', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '235', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '470', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 470}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-27', 'studyFirstSubmitDate': '2004-02-12', 'resultsFirstSubmitDate': '2013-02-13', 'studyFirstSubmitQcDate': '2004-02-13', 'lastUpdatePostDateStruct': {'date': '2013-05-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-27', 'studyFirstPostDateStruct': {'date': '2004-02-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Progression of Disease or Death', 'timeFrame': 'Event driven (after 350 events). Median observation time was approximately 16 months.', 'description': 'Progression Free Survival was defined as the time from the date of randomization to the day of documented disease progression or death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Best Overall Response Being Complete Response (CR) or Partial Response (PR)', 'timeFrame': 'Until Progressive Disease (PD) or end of primary study treatment (up to 16 cycles) plus 28 days.', 'description': 'According to Response Evaluation Criteria in Solid Tumors (RECIST) criteria: CR is defined as the disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the nadir sum LD.'}, {'measure': 'Time to Overall Response', 'timeFrame': 'Until PD or end of primary study treatment (up to 16 cycles) plus 28 days.', 'description': 'For patients with Best Overall Response being Complete Response (CR) or Partial Response (PR), time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR were met. The percentage of participants with overall response within the given time ranges in each of the categories: Weeks 1-6, 7-12, 13-18, 19-24, 25-30, 31-36, and 43-48 are reported.'}, {'measure': 'Duration of Overall Response', 'timeFrame': 'Until PD or death. Median duration of response was approximately 7 months.', 'description': 'Duration of overall response was measured from the time that measurement criteria were first met for Complete Response or Partial Response until the first date that progressive disease or death was documented.'}, {'measure': 'Time to Treatment Failure', 'timeFrame': 'Until premature withdrawal or end of primary study treatment (up to 16 cycles).', 'description': 'The time to treatment failure was the time from the date of randomization to the first occurrence of any of the following events:\n\n* adverse events\n* insufficient therapeutic response (disease progression)\n* death\n* failure to return\n* refusing treatment/being unwilling to cooperate\n* withdrawing consent.'}, {'measure': 'Overall Survival', 'timeFrame': 'Throughout the study. Median observation time was approximately 16 months.', 'description': 'Overall Survival was measured as the time from the date of randomization to the date of death.'}, {'measure': 'Number of Participants With Adverse Events and Serious Adverse Events', 'timeFrame': 'First study drug intake until last study drug intake plus 28 days', 'description': 'An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.\n\nA serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is Life-Threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.\n\nAdditional information about Adverse Events can be found in the Adverse Event Section.'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This 2 arm study compared the efficacy and safety of label dose of capecitabine (Xeloda®) to that of a lower dose of Xeloda® plus docetaxel (Taxotere®) in patients with locally advanced or metastatic breast cancer after failure of chemotherapy with an anthracycline. Patients were randomized to receive either 1250 mg/m\\^2 or 825 mg/m\\^2 orally twice a day (po bid) on days 1-14 of each 3 week cycle, in combination with Taxotere® 75 mg/m2 intravenous (iv) on day 1 of each 3 week cycle. The anticipated time on study treatment was until disease progression and the target sample size was 440 individuals.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women \\>=18 years of age;\n* \\>=1 target lesion;\n* locally advanced or metastatic breast cancer;\n* demonstrated resistance to anthracycline;\n* \\>=2 regimens of chemotherapy for advanced/metastatic disease.\n\nExclusion Criteria:\n\n* previous treatment with Xeloda, continuous 5-fluorouracil infusion, or other oral fluoropyrimidines;\n* previous treatment with paclitaxel or docetaxel for advanced/metastatic disease.'}, 'identificationModule': {'nctId': 'NCT00077857', 'briefTitle': 'A Study to Assess Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic Breast Cancer', 'nctIdAliases': ['NCT00083200'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Open-label Study of the Effect of Different Dosing Regimens of Xeloda® in Combination With Taxotere® on Disease Progression in Patients With Locally Advanced and/or Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'NO16853'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1250 mg/m^2 capecitabine + docetaxel', 'description': '1250 mg/m\\^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m\\^2 intravenous on day 1 of each 3 week cycle.', 'interventionNames': ['Drug: capecitabine (Xeloda®)', 'Drug: docetaxel (Taxotere®)']}, {'type': 'EXPERIMENTAL', 'label': '825 mg/m^2 capecitabine + docetaxel', 'description': '825 mg/m\\^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m\\^2 intravenous on day 1 of each 3 week cycle.', 'interventionNames': ['Drug: capecitabine (Xeloda®)', 'Drug: docetaxel (Taxotere®)']}], 'interventions': [{'name': 'capecitabine (Xeloda®)', 'type': 'DRUG', 'otherNames': ['Xeloda®'], 'description': '825 mg/m\\^2 or 1250 mg/m2 orally twice a day on days 1 to 14 of each 3 week cycle.', 'armGroupLabels': ['1250 mg/m^2 capecitabine + docetaxel', '825 mg/m^2 capecitabine + docetaxel']}, {'name': 'docetaxel (Taxotere®)', 'type': 'DRUG', 'otherNames': ['Taxotere®'], 'description': '75 mg/m\\^2 intravenous on day 1 of each 3 week cycle', 'armGroupLabels': ['1250 mg/m^2 capecitabine + docetaxel', '825 mg/m^2 capecitabine + docetaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35216', 'city': 'Hoover', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.40539, 'lon': -86.81138}}, {'zip': '85715', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 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