Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-29 @ 8:27 PM
Study NCT ID:
NCT01095003
Status:
COMPLETED
Last Update Posted:
2022-04-28
First Post:
2010-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Vinflunine Plus Capecitabine in Advanced 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': 'C111217', 'term': 'vinflunine'}, {'id': 'D000069287', 'term': 'Capecitabine'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Karim.keddad@pierre-fabre.com', 'phone': '+33.5.34.50.61.69', 'title': 'Karim Keddad', 'organization': 'Institut de Recherche Pierre Fabre'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'No limitations and caveats'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) are reported from time of first dose of study treatment up to the end of study period (treatment period + follow-up period) up to 5 years 9 months.', 'description': 'AEs were collected from treated patients who received at least one dose of study treatment (383 patients in each arm). The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another. Specific AE tables were generated separately as per European format.', 'eventGroups': [{'id': 'EG000', 'title': 'Vinflunine Plus Capecitabine', 'description': 'Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks\n\nCapecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks', 'otherNumAtRisk': 383, 'deathsNumAtRisk': 384, 'otherNumAffected': 257, 'seriousNumAtRisk': 383, 'deathsNumAffected': 345, 'seriousNumAffected': 107}, {'id': 'EG001', 'title': 'Capecitabine Single-agent', 'description': 'Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks', 'otherNumAtRisk': 383, 'deathsNumAtRisk': 386, 'otherNumAffected': 262, 'seriousNumAtRisk': 383, 'deathsNumAffected': 348, 'seriousNumAffected': 85}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 32}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cardiac disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 22}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 31}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 78}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 108}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 116}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 123}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 97}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 106}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 62}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 39}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 111}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 92}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hepatobiliary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 20}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 90}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 113}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 74}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 48}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 37}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 25}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 30}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 23}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 33}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 38}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 14}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 34}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 51}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'PPES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 180}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 28}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Ileus paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Reflux gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Haemoytique anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anginal pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Injection site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Multi organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cholecytitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 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'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pneumonia streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Sepsis', 'stats': 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'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypokaelemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Malignant neoplasmprogression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 32}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Malignant pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Paraneoplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Brachial plexopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Intracranial pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Subarachnoid haemorrrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vascular encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dysfunctional uterine bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hydrothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'PPES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anal fistula excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bile duct stent insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Central venous catherisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Haemorrhoid operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 383, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 383, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}, {'value': '386', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vinflunine Plus Capecitabine', 'description': 'Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks\n\nCapecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks'}, {'id': 'OG001', 'title': 'Capecitabine Single-agent', 'description': 'Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '6.3'}, {'value': '4.3', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '5.6'}]}]}], 'analyses': [{'pValue': '0.0426', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.71', 'ciUpperLimit': '0.99', 'groupDescription': 'The final analysis of progression free survival was conducted once the required number of events(615 progressions or deaths) was reached.using the IRC assessment of date of progressions following the blinded radiological and clinical review of data. Kaplan-Meier curves and life tables by treatment arm were provided.A stratified Cox proportional model was used to compare the two treatment arms', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to 2 years 7 months', 'description': 'PFS is defined as time from date of randomization to date of the first documentation of objective tumor progression (according to the Independent Response Review Committee (IRC) and based on RECIST version 1.1) or death due to any cause.\n\nThe PFS was primarily analysed in the Intent-to-treat (ITT) population. Patients lost to follow-up, or without a known record of progression or death at time of analysis had the progression-free survival censored at the date of last tumour assessment or the date of last contact of a follow-up showing no progression, whichever occurs last.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}, {'value': '386', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vinflunine Plus Capecitabine', 'description': 'Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks\n\nCapecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks'}, {'id': 'OG001', 'title': 'Capecitabine Single-agent', 'description': 'Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000', 'lowerLimit': '11.9', 'upperLimit': '15'}, {'value': '11.7', 'groupId': 'OG001', 'lowerLimit': '10.8', 'upperLimit': '13.5'}]}]}], 'analyses': [{'pValue': '0.7657', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.15', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline upto 3 years 10 months', 'description': 'The overall survival (OS) was defined as the duration between the date of randomisation and the date of death from any cause. The OS analysis was performed in the ITT population and the eligible and per protocol populations once the required number of events (631 deaths) was observed Patients lost to follow-up, or without a known record of death at time of analysis had the OS censored at the date of last contact.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}, {'value': '386', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vinflunine Plus Capecitabine', 'description': 'Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks\n\nCapecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks'}, {'id': 'OG001', 'title': 'Capecitabine Single-agent', 'description': 'Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '22.9', 'groupId': 'OG000', 'lowerLimit': '18.8', 'upperLimit': '27.5'}, {'value': '17.9', 'groupId': 'OG001', 'lowerLimit': '14.2', 'upperLimit': '22.1'}]}]}], 'analyses': [{'pValue': '0.103', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline upto 2 years 7 months', 'description': 'ORR defined as documentation of complete or partial response that was subsequently confirmed to first documentation of disease progression or to death due to any cause, whichever occurred first.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}, {'value': '386', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vinflunine Plus Capecitabine', 'description': 'Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks\n\nCapecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks'}, {'id': 'OG001', 'title': 'Capecitabine Single-agent', 'description': 'Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '57.3', 'groupId': 'OG000', 'lowerLimit': '52.2', 'upperLimit': '62.3'}, {'value': '47.9', 'groupId': 'OG001', 'lowerLimit': '42.9', 'upperLimit': '53'}]}]}], 'analyses': [{'pValue': '0.0089', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 2 years 7 months', 'description': 'Disease control rate defined (DCR) as the sum of confirmed complete response, confirmed partial response and stabilisation rate.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}, {'value': '386', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vinflunine Plus Capecitabine', 'description': 'Patients received (in combination with capecitabine)\n\n• Vinflunine at the dose of 280 mg/m² and as a 20-minute IV. infusion on day 1 of each cycle repeated every 3 weeks.\n\nVinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks\n\nCapecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks'}, {'id': 'OG001', 'title': 'Capecitabine Single-agent', 'description': 'Capecitabine at the dose of 825mg/m² per os twice per day each morning and each evening for 14 consecutive days beginning on day 1 of each cycle repeated every 3 weeks (self-administered).\n\nCapecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '57.3', 'groupId': 'OG000', 'lowerLimit': '52.2', 'upperLimit': '62.3'}, {'value': '47.9', 'groupId': 'OG001', 'lowerLimit': '42.9', 'upperLimit': '53'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to 2 years 7 months', 'description': 'Measured from the first time that measurement criteria were first met for objective response (documented CR or PR) until recurrence/progression or death whatever the cause.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vinflunine Plus Capecitabine', 'description': 'Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks\n\nCapecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks'}, {'id': 'FG001', 'title': 'Capecitabine Single-agent', 'description': 'Capecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '384'}, {'groupId': 'FG001', 'numSubjects': '386'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '384'}, {'groupId': 'FG001', 'numSubjects': '386'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'BG000'}, {'value': '384', 'groupId': 'BG001'}, {'value': '770', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Capecitabine Single-agent', 'description': 'Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks'}, {'id': 'BG001', 'title': 'Vinflunine Plus Capecitabine', 'description': 'Vinflunine plus Capecitabine: Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks\n\nCapecitabine: Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '340', 'groupId': 'BG000'}, {'value': '329', 'groupId': 'BG001'}, {'value': '669', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '386', 'groupId': 'BG000'}, {'value': '384', 'groupId': 'BG001'}, {'value': '770', '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 770}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-06', 'studyFirstSubmitDate': '2010-03-24', 'resultsFirstSubmitDate': '2019-05-27', 'studyFirstSubmitQcDate': '2010-03-26', 'lastUpdatePostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-07', 'studyFirstPostDateStruct': {'date': '2010-03-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': 'Baseline up to 2 years 7 months', 'description': 'PFS is defined as time from date of randomization to date of the first documentation of objective tumor progression (according to the Independent Response Review Committee (IRC) and based on RECIST version 1.1) or death due to any cause.\n\nThe PFS was primarily analysed in the Intent-to-treat (ITT) population. Patients lost to follow-up, or without a known record of progression or death at time of analysis had the progression-free survival censored at the date of last tumour assessment or the date of last contact of a follow-up showing no progression, whichever occurs last.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Baseline upto 3 years 10 months', 'description': 'The overall survival (OS) was defined as the duration between the date of randomisation and the date of death from any cause. The OS analysis was performed in the ITT population and the eligible and per protocol populations once the required number of events (631 deaths) was observed Patients lost to follow-up, or without a known record of death at time of analysis had the OS censored at the date of last contact.'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Baseline upto 2 years 7 months', 'description': 'ORR defined as documentation of complete or partial response that was subsequently confirmed to first documentation of disease progression or to death due to any cause, whichever occurred first.'}, {'measure': 'Disease Control Rate', 'timeFrame': 'Baseline up to 2 years 7 months', 'description': 'Disease control rate defined (DCR) as the sum of confirmed complete response, confirmed partial response and stabilisation rate.'}, {'measure': 'Duration of Response', 'timeFrame': 'Baseline up to 2 years 7 months', 'description': 'Measured from the first time that measurement criteria were first met for objective response (documented CR or PR) until recurrence/progression or death whatever the cause.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '29447329', 'type': 'DERIVED', 'citation': 'Martin M, Campone M, Bondarenko I, Sakaeva D, Krishnamurthy S, Roman L, Lebedeva L, Vedovato JC, Aapro M. Randomised phase III trial of vinflunine plus capecitabine versus capecitabine alone in patients with advanced breast cancer previously treated with an anthracycline and resistant to taxane. Ann Oncol. 2018 May 1;29(5):1195-1202. doi: 10.1093/annonc/mdy063.'}]}, 'descriptionModule': {'briefSummary': 'The increasing use of anthracyclines and taxanes in the adjuvant, neoadjuvant and first-line metastatic settings, led to a raise of patients presenting with metastatic breast cancer after treatment with these agents. Options for the treatment of patients who have progressed after an anthracycline and a taxane are limited. The high level of in-vitro synergy of vinflunine combined with 5-fluorouracil (5-FU) together with the good tolerance and the encouraging response rate observed while combining IV vinflunine to oral capecitabine make it a promising combination to investigate further in a phase III trial. This phase III trial will evaluate the effectiveness and the safety profile of such combination for the treatment of patient with advanced breast cancer previously treated with or resistant to anthracycline and taxane resistant.', 'detailedDescription': 'This multicentre, open-label, randomised, Phase III study will enrol 764 patients with advanced breast cancer who have previously been treated with or are resistant to an anthracycline and who are taxane resistant. Patients will be randomised in a 1:1 ratio to receive vinflunine plus capecitabine (Arm A) or capecitabine alone (Arm B).\n\nRandomisation will be stratified according to a minimization procedure:\n\n1. Resistance to anthracyclines ("yes" versus "no"), Relapse ≤ 12 months in the adjuvant or neoadjuvant setting or progression ≤ 4 months in the metastatic setting,\n2. Karnofsky performance status ("90-100" versus "70-80"),\n3. Measurable disease ("yes" versus "no"),\n4. The number of prior lines of chemotherapy in the metastatic setting ("0" versus "1" versus "\\> 1") and,\n5. Study site.\n\nPatients randomised in Arm A will receive:\n\n* Vinflunine at the dose of 280 mg/m² on day 1 of each cycle every 3 weeks, over a 20-minute i.v. infusion and,\n* Capecitabine which will be self-administered by the patient in an outpatient setting. Patients will take 825 mg/m² twice daily per os for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest. A cycle of therapy is defined as 3 weeks.\n\nFor patients randomised in Arm B, capecitabine will be self administered by the patient in an outpatient setting. Patients will take 1250 mg/m² twice daily per os for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest. A cycle of therapy is defined as 3 weeks.\n\nThe doses and timing of treatment will be modified based on toxicities experienced by the patient.\n\nPatients will be assessed for toxicity, tumour response and progression at regular intervals during treatment. Patients will be evaluated for safety if they received any study drug. Laboratory values, adverse events and other symptoms will be graded.\n\nTumour response, progression-free survival and duration of response will be evaluated for all randomised patients. Tumour assessment is to be performed every 6 weeks (+/- 3 working days) from randomisation (regardless of the timing of treatment cycles) until disease progression is documented. Patients who discontinue protocol treatment for reasons other than disease progression will have tumour assessments every 6 weeks until documented disease progression. Patients may continue to receive additional cycles of therapy until progressive disease or intolerable toxicity.\n\nQuality of Life assessment, will be measured by EORTC QLQ-C30 and QLQ-BR23 questionnaires, which will be completed by patients.\n\nThe primary endpoint for the trial is progression free survival calculated from the date of randomization until the date of progression or the date of death whatever the reason of death. The analysis of Progression-Free Survival is planned to take place when 615 progressions or deaths have been observed. One interim safety analysis is planned and will take place when 50 patients of each arm have completed at least one cycle of study treatment. It is anticipated that up to 170 active study centres will participate, and that accrual will be completed in approximately 30 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female patients\n* 21 years of age or older\n* histologically/cytologically confirmed carcinoma of the breast\n* documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy\n* either one, two or three prior chemotherapy regimens\n* prior treatments including both an anthracycline and a taxane and patient no longer candidate for these drugs\n* measurable or non-measurable disease according to RECIST 1.1\n* Karnofsky performance score of at least 70 %\n* adequate haematological, hepatic and renal functions\n* ECG without clinically relevant abnormality\n\nExclusion Criteria:\n\n* known or clinical evidence of brain metastasis or leptomeningeal involvement\n* pulmonary lymphangitis or symptomatic pleural effusion\n* any serious, concurrent uncontrolled medical disorder\n* history of second primary malignancy\n* preexisting motor/sensory peripheral neuropathy\n* known history of HIV infection\n* prior therapy with capecitabine and/or vinca-alkaloids\n* history of severe hypersensitivity to vinca alkaloids and/or to fluoropyrimidine or contra indication to any of these drugs\n* known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency\n* pregnancy or breast feeding'}, 'identificationModule': {'nctId': 'NCT01095003', 'briefTitle': 'Trial of Vinflunine Plus Capecitabine in Advanced Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pierre Fabre Medicament'}, 'officialTitle': 'A Phase III Trial of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With or Resistant to an Anthracycline and Who Are Taxane Resistant.', 'orgStudyIdInfo': {'id': 'L00070 IN 305 B0'}, 'secondaryIdInfos': [{'id': '2008-004171-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vinflunine plus Capecitabine', 'description': 'Patients received (in combination with capecitabine)\n\n• Vinflunine at the dose of 280 mg/m² and as a 20-minute IV. infusion on day 1 of each cycle repeated every 3 weeks.', 'interventionNames': ['Drug: Vinflunine plus Capecitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Capecitabine single-agent', 'description': 'Capecitabine at the dose of 825mg/m² per os twice per day each morning and each evening for 14 consecutive days beginning on day 1 of each cycle repeated every 3 weeks (self-administered).', 'interventionNames': ['Drug: Capecitabine']}], 'interventions': [{'name': 'Vinflunine plus Capecitabine', 'type': 'DRUG', 'otherNames': ['JAVLOR', 'L00070 IN'], 'description': 'Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks\n\nCapecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks', 'armGroupLabels': ['Vinflunine plus Capecitabine']}, {'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['XELODA'], 'description': 'Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks', 'armGroupLabels': ['Capecitabine single-agent']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Quilmes', 'country': 'Argentina', 'geoPoint': {'lat': -34.72065, 'lon': -58.25454}}, {'city': 'Rosario', 'country': 'Argentina', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'city': 'San Martín', 'country': 'Argentina', 'geoPoint': {'lat': -33.08338, 'lon': -68.47312}}, {'city': 'San Miguel de Tucumán', 'country': 'Argentina', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'city': 'Grodno', 'country': 'Belarus', 'geoPoint': {'lat': 53.62865, 'lon': 23.8942}}, {'city': 'Homyel', 'country': 'Belarus', 'geoPoint': {'lat': 52.4345, 'lon': 30.9754}}, {'city': 'Minsk', 'country': 'Belarus', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'city': 'Vitebsk', 'country': 'Belarus', 'geoPoint': {'lat': 55.1904, 'lon': 30.2049}}, {'city': 'Brussels', 'country': 'Belgium', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Liège', 'country': 'Belgium', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Curitiba', 'country': 'Brazil', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'city': 'Porto Alegre', 'country': 'Brazil', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Santo André', 'country': 'Brazil', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}, {'city': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Plovdiv', 'country': 'Bulgaria', 'geoPoint': {'lat': 42.15387, 'lon': 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