Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-26 @ 1:40 PM
Study NCT ID:
NCT00528567
Status:
COMPLETED
Last Update Posted:
2015-09-04
First Post:
2007-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Serbia and Montenegro']}, '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': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'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': {'timeFrame': 'Through end of study, 30 June 2014', 'description': 'The analysis set was the safety population, defined as all randomized participants who received at least one dose of study drug. Participants who received at least one full or partial dose of bevacizumab were included in the bevacizumab and chemotherapy arm; all others, in the chemotherapy arm. MedDRA (15.0) and MedDRA (17.0) were used.', 'eventGroups': [{'id': 'EG000', 'title': 'Bevacizumab and Chemotherapy (0-18 Months)', 'description': 'Occurring in participants who received bevacizumab and chemotherapy, during treatment period (0-18 months) after first dose', 'otherNumAtRisk': 1288, 'otherNumAffected': 1268, 'seriousNumAtRisk': 1288, 'seriousNumAffected': 379}, {'id': 'EG001', 'title': 'Chemotherapy (0-18 Months)', 'description': 'Occurring in participants who received chemotherapy alone, during treatment period (0-18 months) after first dose', 'otherNumAtRisk': 1271, 'otherNumAffected': 1233, 'seriousNumAtRisk': 1271, 'seriousNumAffected': 250}, {'id': 'EG002', 'title': 'Bevacizumab and Chemotherapy (>18 Months)', 'description': 'Occurring in participants who received bevacizumab and chemotherapy, during follow-up period (\\>18 months) after first dose', 'otherNumAtRisk': 1288, 'otherNumAffected': 0, 'seriousNumAtRisk': 1288, 'seriousNumAffected': 45}, {'id': 'EG003', 'title': 'Chemotherapy (>18 Months)', 'description': 'Occurring in participants who received chemotherapy alone, during follow-up period (\\>18 months) after first dose', 'otherNumAtRisk': 1271, 'otherNumAffected': 0, 'seriousNumAtRisk': 1271, 'seriousNumAffected': 48}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 881}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 880}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 663}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 469}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 480}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 459}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 444}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 401}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 418}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 350}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 201}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 165}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 138}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 112}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 123}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 124}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 138}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 76}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 58}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 807}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 833}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 183}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 150}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 160}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 137}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 114}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Palmar-Plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 70}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 72}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 63}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 49}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 533}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 539}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 230}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 223}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 214}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 164}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 145}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 164}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 58}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 61}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 414}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 252}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 278}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 273}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 198}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 171}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 172}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 141}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 111}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 440}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 289}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 243}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 230}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 138}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 135}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 137}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 128}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 130}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 121}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 91}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 503}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 479}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 210}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 215}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 140}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 175}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 478}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 75}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 215}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 161}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 179}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 99}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 144}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 123}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 104}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 65}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 456}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 65}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 206}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 208}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 74}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 137}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 125}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 103}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 109}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 100}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 191}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 217}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 78}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 69}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 260}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 223}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 103}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 71}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 49}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 45}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 50}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 28}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 261}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 165}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Radiation skin injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 151}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 190}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 156}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 109}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 195}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 24}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 86}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 162}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 123}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 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'EG001', 'numAtRisk': 1271, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': "Bowen's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemangioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oesophageal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 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'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hypoxic-ischaemic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 1}], 'organSystem': 'Nervous 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'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adenomyosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast calcifications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysfunctional uterine bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertrophic scar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1271, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1288, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1271, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Invasive Disease-free Survival (IDFS) Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1301', 'groupId': 'OG000'}, {'value': '1290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Chemotherapy', 'description': 'Participants randomized to receive bevacizumab and chemotherapy'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants randomized to receive chemotherapy alone'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median was not reached.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median was not reached.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.1810', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.07', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Event driven (until data cutoff: 29 February 2012: up to 49 months)', 'description': 'IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, defined as all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Time to Overall Survival (OS) Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1301', 'groupId': 'OG000'}, {'value': '1290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Chemotherapy', 'description': 'Participants randomized to receive bevacizumab and chemotherapy'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants randomized to receive chemotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median was not reached', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median was not reached', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Event driven (until data cutoff: 29 February 2012: up to 49 months)', 'description': 'OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, defined as all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Time to Overall Survival (OS) Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1301', 'groupId': 'OG000'}, {'value': '1290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Chemotherapy', 'description': 'Participants randomized to receive bevacizumab and chemotherapy'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants randomized to receive chemotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median was not estimable.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median was not estimable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.5247', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.17', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratification factors are Axillary nodal status, Choice of adjuvant chemotherapy, Hormone receptor status, Surgery', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Event driven (until data cutoff: 30 June 2014: up to 77 months)', 'description': 'OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, defined as all randomized participants.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Invasive Disease-free Survival (IDFS) Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1301', 'groupId': 'OG000'}, {'value': '1290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Chemotherapy', 'description': 'Participants randomized to receive bevacizumab and chemotherapy'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants randomized to receive chemotherapy alone'}], 'classes': [{'title': 'Percentage of Participants with Events', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000'}, {'value': '15.9', 'groupId': 'OG001'}]}]}, {'title': 'Percentage of Participants without Events', 'categories': [{'measurements': [{'value': '85.5', 'groupId': 'OG000'}, {'value': '84.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Event driven (until data cutoff: 29 February 2012 up to 49 months)', 'description': 'IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer. The percentage of participants with and without IDFS Events by the time of the data cutoff is presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, defined as all randomized participants.'}, {'type': 'PRIMARY', 'title': 'Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1301', 'groupId': 'OG000'}, {'value': '1290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Chemotherapy', 'description': 'Participants randomized to receive bevacizumab and chemotherapy'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants randomized to receive chemotherapy alone'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median was not reached.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median was not reached.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.1966', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.07', 'estimateComment': 'Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Event driven (until data cutoff: 29 February 2012: up to 49 months)', 'description': 'IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, defined as all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Overall Survival (OS) Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1301', 'groupId': 'OG000'}, {'value': '1290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Chemotherapy', 'description': 'Participants randomized to receive bevacizumab and chemotherapy'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants randomized to receive chemotherapy'}], 'classes': [{'title': 'with events', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'without events', 'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000'}, {'value': '91.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2318', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.12', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Event driven (until data cut off: 29 February 2012: up to 49 months)', 'description': 'OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, defined as all randomized participants.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1301', 'groupId': 'OG000'}, {'value': '1290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Chemotherapy', 'description': 'Participants randomized to receive bevacizumab and chemotherapy'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants randomized to receive chemotherapy alone'}], 'classes': [{'title': 'Percentage of Participants with Events', 'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000'}, {'value': '14.7', 'groupId': 'OG001'}]}]}, {'title': 'Percentage of Participants without Events', 'categories': [{'measurements': [{'value': '86.5', 'groupId': 'OG000'}, {'value': '85.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Event driven (until data cutoff: 29 February 2012: up to 49 months)', 'description': 'IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer. Percentage of participants with and without IDFS Events by the time of data cutoff is presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, defined as all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Overall Survival (OS) Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1301', 'groupId': 'OG000'}, {'value': '1290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Chemotherapy', 'description': 'Participants randomized to receive bevacizumab and chemotherapy'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants randomized to receive chemotherapy'}], 'classes': [{'title': 'with events', 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}, {'value': '11.6', 'groupId': 'OG001'}]}]}, {'title': 'without events', 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000'}, {'value': '88.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Event driven (until data cut off: 30 June 2014: up to 77 months)', 'description': 'OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, defined as all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Time to Breast Cancer-Free Interval (BCFI) Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1301', 'groupId': 'OG000'}, {'value': '1290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Chemotherapy', 'description': 'Participants randomized to receive bevacizumab and chemotherapy'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants randomized to receive chemotherapy alone'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median was not reached.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median was not reached.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.2792', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.10', 'estimateComment': 'Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Event driven (until data cutoff: 29 February 2012: up to 49 months)', 'description': 'BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral Ductal carcinoma in situ or Death only from breast cancer cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat participants, defined as all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1301', 'groupId': 'OG000'}, {'value': '1290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Chemotherapy', 'description': 'Participants randomized to receive bevacizumab and chemotherapy'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants randomized to receive chemotherapy alone'}], 'classes': [{'title': 'Percentage of Participants with Events', 'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000'}, {'value': '14.2', 'groupId': 'OG001'}]}]}, {'title': 'Percentage of Participants without Events', 'categories': [{'measurements': [{'value': '86.8', 'groupId': 'OG000'}, {'value': '85.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Event driven (until data cutoff: 29 February 2012: up to 49 months)', 'description': 'BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral DCIS or Death only from breast cancer cause. Percentage of participants with and without BCFI events by the time of the data cutoff is presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, defined as all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Time to Disease-Free Survival (DFS) Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1301', 'groupId': 'OG000'}, {'value': '1290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Chemotherapy', 'description': 'Participants randomized to receive bevacizumab and chemotherapy'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants randomized to receive chemotherapy alone'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median was not reached.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median was not reached.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.1832', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.07', 'estimateComment': 'Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Event driven (until data cutoff: 29 February 2012: up to 49 months)', 'description': 'DFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer, Second primary non-breast invasive cancer or New diagnosis of an ipsilateral or contralateral Ductal carcinoma in situ (DCIS).', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, defined as all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Disease-Free Survival (DFS) Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1301', 'groupId': 'OG000'}, {'value': '1290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Chemotherapy', 'description': 'Participants randomized to receive bevacizumab and chemotherapy'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants randomized to receive chemotherapy alone'}], 'classes': [{'title': 'with Events', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}]}]}, {'title': 'without Events', 'categories': [{'measurements': [{'value': '85.3', 'groupId': 'OG000'}, {'value': '83.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Event driven (until data cutoff: 29 February 2012: up to 49 months)', 'description': 'DFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer, Second primary non-breast invasive cancer or New diagnosis of an ipsilateral or contralateral Ductal carcinoma in situ (DCIS). Percentage of Participants with and without DFI Events by the time of the data cut-off is presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, defined as all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Time to Distant Disease-Free Survival (DDFS) Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1301', 'groupId': 'OG000'}, {'value': '1290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Chemotherapy', 'description': 'Participants randomized to receive bevacizumab and chemotherapy'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants randomized to receive chemotherapy alone'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median was not reached.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median was not reached', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.3309', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.12', 'estimateComment': 'Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Event driven (until data cutoff: 29 February 2012: up to 49 months)', 'description': 'DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers).', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, defined as all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Distant Disease-Free Survival (DDFS) Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1301', 'groupId': 'OG000'}, {'value': '1290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Chemotherapy', 'description': 'Participants randomized to receive bevacizumab and chemotherapy'}, {'id': 'OG001', 'title': 'Chemotherapy', 'description': 'Participants randomized to receive chemotherapy alone'}], 'classes': [{'title': 'Percentage of Participants with Events', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000'}, {'value': '12.7', 'groupId': 'OG001'}]}]}, {'title': 'Percentage of Participants without Events', 'categories': [{'measurements': [{'value': '88.3', 'groupId': 'OG000'}, {'value': '87.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Event driven (until data cutoff: 29 February 2012: up to 49 months)', 'description': 'DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers). Percentage of participants with and without DDFS Events by the time of the data cutoff is presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, defined as all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1288', 'groupId': 'OG000'}, {'value': '1271', 'groupId': 'OG001'}, {'value': '1288', 'groupId': 'OG002'}, {'value': '1271', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Chemotherapy (0-18 Months)', 'description': 'Occurring in participants who received bevacizumab and chemotherapy, 0-18 months after first dose'}, {'id': 'OG001', 'title': 'Chemotherapy (0-18 Months)', 'description': 'Occurring in participants who received chemotherapy alone, 0-18 months after first dose'}, {'id': 'OG002', 'title': 'Bevacizumab and Chemotherapy (>18 Months)', 'description': 'Occurring in participants who received bevacizumab and chemotherapy, more than 18 months after first dose'}, {'id': 'OG003', 'title': 'Chemotherapy (>18 Months)', 'description': 'Occurring in participants who received chemotherapy alone, more than 18 months after first dose'}], 'classes': [{'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '379', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}]}, {'title': 'Adverse Events (5% Reporting Threshold)', 'categories': [{'measurements': [{'value': '1268', 'groupId': 'OG000'}, {'value': '1233', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through end of study: 30 June 2014: up to 77 months', '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population, defined as all randomized participants who received at least one dose of study drug. Participants who received at least one full or partial dose of bevacizumab were included in the bevacizumab and chemotherapy arm; all other patients were analyzed in the chemotherapy arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bevacizumab and Chemotherapy', 'description': 'Participants randomized to receive bevacizumab and chemotherapy.\n\nFor these patients, bevacizumab was given in combination with chemotherapy at a dose of 5 mg/kg/week equivalent using 1 of 3 different scheduling options depending on the schedule of the adjuvant chemotherapy selected. After completing chemotherapy + bevacizumab (treatment period 1), patients in this arm received bevacizumab monotherapy up to a total duration of 1 year (treatment period 2).\n\nAt the end of treatment (i.e., after approximately 55 weeks), patients were followed up until the end of the study.'}, {'id': 'FG001', 'title': 'Chemotherapy', 'description': 'Participants randomized to receive chemotherapy alone.\n\nFor patients randomized to the chemotherapy alone arm, investigators could select from one of three chemotherapy regimens. After completing chemotherapy (treatment period 1) patients entered a post-treatment surveillance period for the remainder of the first year after randomization (treatment period 2).\n\nAt the end of treatment (i.e., after approximately 55 weeks), patients were followed up until the end of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1301'}, {'groupId': 'FG001', 'numSubjects': '1290'}]}, {'type': 'Intention to Treat', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1301'}, {'groupId': 'FG001', 'numSubjects': '1290'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1288'}, {'groupId': 'FG001', 'numSubjects': '1271'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '870'}, {'groupId': 'FG001', 'numSubjects': '982'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '431'}, {'groupId': 'FG001', 'numSubjects': '308'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Breast Cancer Recurrence/2nd Primary', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'Adverse Event/Intermittent Illness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '255'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Violation Criteria at Entry', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'Refused Treatment/Did Not Cooperate', 'reasons': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'Failure to Return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Other Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Administrative/Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '75'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1301', 'groupId': 'BG000'}, {'value': '1290', 'groupId': 'BG001'}, {'value': '2591', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bevacizumab and Chemotherapy', 'description': 'Participants randomized to receive bevacizumab and chemotherapy'}, {'id': 'BG001', 'title': 'Chemotherapy', 'description': 'Participants randomized to receive chemotherapy alone'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 40 years', 'categories': [{'measurements': [{'value': '231', 'groupId': 'BG000'}, {'value': '253', 'groupId': 'BG001'}, {'value': '484', 'groupId': 'BG002'}]}]}, {'title': '>= 40 to < 65 years', 'categories': [{'measurements': [{'value': '952', 'groupId': 'BG000'}, {'value': '916', 'groupId': 'BG001'}, {'value': '1868', 'groupId': 'BG002'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1301', 'groupId': 'BG000'}, {'value': '1290', 'groupId': 'BG001'}, {'value': '2591', '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': 2591}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-05', 'studyFirstSubmitDate': '2007-09-11', 'resultsFirstSubmitDate': '2013-02-28', 'studyFirstSubmitQcDate': '2007-09-11', 'lastUpdatePostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-06-28', 'studyFirstPostDateStruct': {'date': '2007-09-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Invasive Disease-free Survival (IDFS) Event', 'timeFrame': 'Event driven (until data cutoff: 29 February 2012: up to 49 months)', 'description': 'IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer.'}, {'measure': 'Percentage of Participants With Invasive Disease-free Survival (IDFS) Events', 'timeFrame': 'Event driven (until data cutoff: 29 February 2012 up to 49 months)', 'description': 'IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer. The percentage of participants with and without IDFS Events by the time of the data cutoff is presented.'}, {'measure': 'Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer', 'timeFrame': 'Event driven (until data cutoff: 29 February 2012: up to 49 months)', 'description': 'IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer.'}, {'measure': 'Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer', 'timeFrame': 'Event driven (until data cutoff: 29 February 2012: up to 49 months)', 'description': 'IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer. Percentage of participants with and without IDFS Events by the time of data cutoff is presented.'}], 'secondaryOutcomes': [{'measure': 'Time to Overall Survival (OS) Event', 'timeFrame': 'Event driven (until data cutoff: 29 February 2012: up to 49 months)', 'description': 'OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.'}, {'measure': 'Time to Overall Survival (OS) Event', 'timeFrame': 'Event driven (until data cutoff: 30 June 2014: up to 77 months)', 'description': 'OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.'}, {'measure': 'Percentage of Participants With Overall Survival (OS) Event', 'timeFrame': 'Event driven (until data cut off: 29 February 2012: up to 49 months)', 'description': 'OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.'}, {'measure': 'Percentage of Participants With Overall Survival (OS) Event', 'timeFrame': 'Event driven (until data cut off: 30 June 2014: up to 77 months)', 'description': 'OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.'}, {'measure': 'Time to Breast Cancer-Free Interval (BCFI) Event', 'timeFrame': 'Event driven (until data cutoff: 29 February 2012: up to 49 months)', 'description': 'BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral Ductal carcinoma in situ or Death only from breast cancer cause.'}, {'measure': 'Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events', 'timeFrame': 'Event driven (until data cutoff: 29 February 2012: up to 49 months)', 'description': 'BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral DCIS or Death only from breast cancer cause. Percentage of participants with and without BCFI events by the time of the data cutoff is presented.'}, {'measure': 'Time to Disease-Free Survival (DFS) Event', 'timeFrame': 'Event driven (until data cutoff: 29 February 2012: up to 49 months)', 'description': 'DFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer, Second primary non-breast invasive cancer or New diagnosis of an ipsilateral or contralateral Ductal carcinoma in situ (DCIS).'}, {'measure': 'Percentage of Participants With Disease-Free Survival (DFS) Events', 'timeFrame': 'Event driven (until data cutoff: 29 February 2012: up to 49 months)', 'description': 'DFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer, Second primary non-breast invasive cancer or New diagnosis of an ipsilateral or contralateral Ductal carcinoma in situ (DCIS). Percentage of Participants with and without DFI Events by the time of the data cut-off is presented.'}, {'measure': 'Time to Distant Disease-Free Survival (DDFS) Event', 'timeFrame': 'Event driven (until data cutoff: 29 February 2012: up to 49 months)', 'description': 'DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers).'}, {'measure': 'Percentage of Participants With Distant Disease-Free Survival (DDFS) Events', 'timeFrame': 'Event driven (until data cutoff: 29 February 2012: up to 49 months)', 'description': 'DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers). Percentage of participants with and without DDFS Events by the time of the data cutoff is presented.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths', 'timeFrame': 'Through end of study: 30 June 2014: up to 77 months', '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.'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '27993816', 'type': 'DERIVED', 'citation': 'Bell R, Brown J, Parmar M, Toi M, Suter T, Steger GG, Pivot X, Mackey J, Jackisch C, Dent R, Hall P, Xu N, Morales L, Provencher L, Hegg R, Vanlemmens L, Kirsch A, Schneeweiss A, Masuda N, Overkamp F, Cameron D. Final efficacy and updated safety results of the randomized phase III BEATRICE trial evaluating adjuvant bevacizumab-containing therapy in triple-negative early breast cancer. Ann Oncol. 2017 Apr 1;28(4):754-760. doi: 10.1093/annonc/mdw665.'}, {'pmid': '23932548', 'type': 'DERIVED', 'citation': 'Cameron D, Brown J, Dent R, Jackisch C, Mackey J, Pivot X, Steger GG, Suter TM, Toi M, Parmar M, Laeufle R, Im YH, Romieu G, Harvey V, Lipatov O, Pienkowski T, Cottu P, Chan A, Im SA, Hall PS, Bubuteishvili-Pacaud L, Henschel V, Deurloo RJ, Pallaud C, Bell R. Adjuvant bevacizumab-containing therapy in triple-negative breast cancer (BEATRICE): primary results of a randomised, phase 3 trial. Lancet Oncol. 2013 Sep;14(10):933-42. doi: 10.1016/S1470-2045(13)70335-8. Epub 2013 Aug 7.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of the trial is to compare Invasive Disease-Free Survival (IDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy with 1 year of bevacizumab.\n\nThe secondary objectives of this trial are to:\n\n* compare Overall Survival (OS), Breast Cancer-Free Interval (BCFI), Disease- Free Survival (DFS) and Distant Disease-Free Survival (DDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy in combination with 1 year of bevacizumab\n* evaluate the safety and tolerability of bevacizumab\n\nAn exploratory sub-study (not reported here) was to identify biomarkers (from tumour or serum) predictive of toxicity and for the level of benefit from the addition of bevacizumab to standard adjuvant systemic treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, \\>=18 years of age;\n* operable primary invasive breast cancer;\n* completed definitive loco-regional surgery;\n* primary tumor centrally confirmed as triple negative.\n\nExclusion Criteria:\n\n* locally advanced breast cancers;\n* previous breast cancer history;\n* clinically significant cardiovascular disease.'}, 'identificationModule': {'nctId': 'NCT00528567', 'briefTitle': 'BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An International Multi-centre Open-label 2-arm Phase III Trial of Adjuvant Bevacizumab in "Triple Negative" Breast Cancer.', 'orgStudyIdInfo': {'id': 'BO20289'}, 'secondaryIdInfos': [{'id': '2007-001128-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bevacizumab and Chemotherapy', 'description': 'Participants randomized to receive bevacizumab in combination with chemotherapy as prescribed.', 'interventionNames': ['Drug: Bevacizumab', 'Drug: Standard adjuvant chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chemotherapy', 'description': 'Participants randomized to receive standard adjuvant chemotherapy as prescribed.', 'interventionNames': ['Drug: Standard adjuvant chemotherapy']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'Bevacizumab was administered at a dose equivalent of 5 mg/kg/week using 1 of 3 different scheduling options depending on the schedule of the adjuvant chemotherapy regimen selected for an individual patient.', 'armGroupLabels': ['Bevacizumab and Chemotherapy']}, {'name': 'Standard adjuvant chemotherapy', 'type': 'DRUG', 'description': 'All chemotherapy schedules and doses for each patient were prescribed according to the labeled indication of the country in which 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