Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2026-02-28 @ 10:03 PM
Study NCT ID:
NCT01998906
Status:
COMPLETED
Last Update Posted:
2014-10-28
First Post:
2013-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally 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': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D017239', 'term': 'Paclitaxel'}], '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'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', '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': 'BL, presurgery treatment Cycles 1-10, postsurgery Cycles 1-17, every 6 months thereafter for up to 60 months; yearly thereafter until primary analysis has taken place, after which serious adverse events were collected only if treatment related.', 'description': 'The safety analysis population included all participants randomized in the main study or registered in the parallel observational arm who received at least 1 dose of study medication. 20 participants in the HER2+C group crossed over to receive adjuvant trastuzumab after surgery; these participants were included in the HER+C group below.', 'eventGroups': [{'id': 'EG000', 'title': 'HER2+ TC', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, (collectively CMF) on Day 1, followed by 2 weeks off.\n\nCycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Days 1 and 8, followed by 1 week off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.', 'otherNumAtRisk': 115, 'otherNumAffected': 113, 'seriousNumAtRisk': 115, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'HER2+ C', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.', 'otherNumAtRisk': 112, 'otherNumAffected': 112, 'seriousNumAtRisk': 112, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'HER2- C', 'description': 'Participants with HER2- breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.', 'otherNumAtRisk': 99, 'otherNumAffected': 98, 'seriousNumAtRisk': 99, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 88}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 70}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 58}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 5}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Radiation skin injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 31}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Neurotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sensory disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Amenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 14}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Menstruation irregular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 11}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 87}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 90}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Alopecia totalis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Wound abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Tumour ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Event-Free Survival (EFS) - Percentage of Participants With an Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HER2+ TC', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.\n\nCycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.'}, {'id': 'OG001', 'title': 'HER2+ C', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}, {'id': 'OG002', 'title': 'HER2- C', 'description': 'Participants with HER2- breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '47.7', 'upperLimit': 'NA'}, {'value': '50.9', 'groupId': 'OG001', 'lowerLimit': '24.1', 'upperLimit': 'NA'}, {'value': '42.4', 'groupId': 'OG002', 'lowerLimit': '57.7', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (BL), Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter', 'description': 'EFS was defined as the time between randomization and date of documented occurrence of disease recurrence or progression (local, regional, distant or contralateral) or death due to any cause.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) included all participants who were randomized in the main study or registered in the parallel observational arm.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Breast Pathological Complete Response (bpCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HER2+ TC', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.\n\nCycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.'}, {'id': 'OG001', 'title': 'HER2+ C', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}, {'id': 'OG002', 'title': 'HER2- C', 'description': 'Participants with HER2- breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.3', 'groupId': 'OG000', 'lowerLimit': '35.1', 'upperLimit': '53.9'}, {'value': '26.7', 'groupId': 'OG001', 'lowerLimit': '18.9', 'upperLimit': '35.7'}, {'value': '19.2', 'groupId': 'OG002', 'lowerLimit': '12.0', 'upperLimit': '28.3'}]}]}], 'analyses': [{'pValue': '0.0051', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.6', 'ciLowerLimit': '5.0', 'ciUpperLimit': '30.2', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'BL, Day 1 of Cycles 1-10 (pre-surgery)', 'description': 'bpCR was defined as an absence of any invasive cancer cell of the primary tumor at the time of major surgery after neoadjuvant chemotherapy with and without trastuzumab.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Total Pathological Complete Response (tpCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HER2+ TC', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.\n\nCycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.'}, {'id': 'OG001', 'title': 'HER2+ C', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}, {'id': 'OG002', 'title': 'HER2- C', 'description': 'Participants with HER2- breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '31.0', 'upperLimit': '49.6'}, {'value': '20.7', 'groupId': 'OG001', 'lowerLimit': '13.7', 'upperLimit': '29.2'}, {'value': '18.2', 'groupId': 'OG002', 'lowerLimit': '11.1', 'upperLimit': '27.2'}]}]}], 'analyses': [{'pValue': '0.0014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.3', 'ciLowerLimit': '7.2', 'ciUpperLimit': '31.4', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'BL, Day 1 of Cycles 1-10 (pre-surgery)', 'description': 'tpCR was defined as a determination of bpCR and an absence of positive axillary nodes on pathology.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Either Complete Response (CR) or Partial Response (PR) According to Modified Response Evaluation Criteria in Solid Tumors (RECIST) Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HER2+ TC', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.\n\nCycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.'}, {'id': 'OG001', 'title': 'HER2+ C', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}, {'id': 'OG002', 'title': 'HER2- C', 'description': 'Participants with HER2- breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000', 'lowerLimit': '63.4', 'upperLimit': '80.8'}, {'value': '66.4', 'groupId': 'OG001', 'lowerLimit': '56.6', 'upperLimit': '75.2'}, {'value': '65.6', 'groupId': 'OG002', 'lowerLimit': '55.2', 'upperLimit': '75.0'}]}]}], 'analyses': [{'pValue': '0.3077', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.4', 'ciLowerLimit': '-6.4', 'ciUpperLimit': '19.1', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'BL, Presurgery: Day 1 of Cycles 1-10', 'description': 'Assessments were made based on objective tumor measurements of the lesions as recorded in the case report form. In inflammatory cancer, progressive disease (PD) was defined as progression of any of the 2 signs of breast edema and erythema. In non-inflammatory cancer, PD was concluded if either the investigator judged the participant as having progressed at any time prior to surgery, or there was at least a 20% increase in the sum of target lesions (TLs), any new lesion, or clear progression of any nontarget lesion (NTLs). Clear progression of any NTL was defined as at least a 20% increase in the sum of NTLs compared to BL. PR was defined as at least a 30% decrease from BL in the sum of the longest diameter of TLs. CR was defined as no PD as assessed by the investigator and complete disappearance of all lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) - Percentage of Participants With an Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HER2+ TC', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.\n\nCycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.'}, {'id': 'OG001', 'title': 'HER2+ C', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}, {'id': 'OG002', 'title': 'HER2- C', 'description': 'Participants with HER2- breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '28.4', 'groupId': 'OG001', 'lowerLimit': '58.2', 'upperLimit': 'NA'}, {'value': '21.2', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter', 'description': 'OS was defined as the time from the date of randomization to the date of the death due to any cause.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Event-Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HER2+ TC', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.\n\nCycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.'}, {'id': 'OG001', 'title': 'HER2+ C', 'description': 'Participants with HER2+ breast cancer received doxorubicin, paclitaxel and CMF as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.'}, {'id': 'OG002', 'title': 'HER2- C', 'description': 'Participants with HER2- breast cancer received doxorubicin, paclitaxel, and CMF as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and upper limit of the 95 percent (%) confidence interval (CI) could not be calculated due to an insufficient number of events at the time of analysis.', 'groupId': 'OG000', 'lowerLimit': '47.7', 'upperLimit': 'NA'}, {'value': '43.6', 'comment': 'Upper limit of the 95% CI could not be calculated due to an insufficient number of events at the time of analysis.', 'groupId': 'OG001', 'lowerLimit': '24.1', 'upperLimit': 'NA'}, {'value': '64.5', 'comment': 'Upper limit of the 95% CI could not be calculated due to an insufficient number of events at the time of analysis.', 'groupId': 'OG002', 'lowerLimit': '57.7', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0275', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.44', 'ciUpperLimit': '0.96', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter', 'description': 'The median time, in months, between randomization and date of documented occurrence of an EFS event.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Event Free at 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HER2+ TC', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.\n\nCycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.'}, {'id': 'OG001', 'title': 'HER2+ C', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}, {'id': 'OG002', 'title': 'HER2- C', 'description': 'Participants with HER2- breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '95'}, {'value': '82', 'groupId': 'OG001', 'lowerLimit': '74', 'upperLimit': '89'}, {'value': '80', 'groupId': 'OG002', 'lowerLimit': '73', 'upperLimit': '88'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HER2+ TC', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.\n\nCycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.'}, {'id': 'OG001', 'title': 'HER2+ C', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}, {'id': 'OG002', 'title': 'HER2- C', 'description': 'Participants with HER2- breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 95% CI could not be estimated at the time of data analysis due to the (expected) long survival duration of participants in the trial.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and upper limit of the 95% CI could not be estimated at the time of data analysis due to the (expected) long survival duration of participants in the trial.', 'groupId': 'OG001', 'lowerLimit': '58.2', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI could not be estimated at the time of data analysis due to the (expected) long survival duration of participants in the trial.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0555', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '0.35', 'ciUpperLimit': '1.02', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter', 'description': 'OS was defined as the time from the date of randomization to the date of the death due to any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Surviving at 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HER2+ TC', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.\n\nCycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.'}, {'id': 'OG001', 'title': 'HER2+ C', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}, {'id': 'OG002', 'title': 'HER2- C', 'description': 'Participants with HER2- breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG001', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '97', 'groupId': 'OG002', 'lowerLimit': '93', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Event Free at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HER2+ TC', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.\n\nCycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.'}, {'id': 'OG001', 'title': 'HER2+ C', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}, {'id': 'OG002', 'title': 'HER2- C', 'description': 'Participants with HER2- breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000', 'lowerLimit': '64', 'upperLimit': '81'}, {'value': '61', 'groupId': 'OG001', 'lowerLimit': '51', 'upperLimit': '70'}, {'value': '69', 'groupId': 'OG002', 'lowerLimit': '60', 'upperLimit': '78'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Surviving at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HER2+ TC', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.\n\nCycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.'}, {'id': 'OG001', 'title': 'HER2+ C', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}, {'id': 'OG002', 'title': 'HER2- C', 'description': 'Participants with HER2- breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '99'}, {'value': '88', 'groupId': 'OG001', 'lowerLimit': '82', 'upperLimit': '94'}, {'value': '90', 'groupId': 'OG002', 'lowerLimit': '83', 'upperLimit': '96'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Event Free at 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HER2+ TC', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, (collectively CMF) on Day 1, followed by 2 weeks off.\n\nCycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Days 1 and 8, followed by 1 week off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.'}, {'id': 'OG001', 'title': 'HER2+ C', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}, {'id': 'OG002', 'title': 'HER2- C', 'description': 'Participants with HER2- breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '74'}, {'value': '52', 'groupId': 'OG001', 'lowerLimit': '43', 'upperLimit': '62'}, {'value': '63', 'groupId': 'OG002', 'lowerLimit': '53', 'upperLimit': '72'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Surviving at 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HER2+ TC', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.\n\nCycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.'}, {'id': 'OG001', 'title': 'HER2+ C', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}, {'id': 'OG002', 'title': 'HER2- C', 'description': 'Participants with HER2- breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '79', 'upperLimit': '92'}, {'value': '78', 'groupId': 'OG001', 'lowerLimit': '70', 'upperLimit': '86'}, {'value': '85', 'groupId': 'OG002', 'lowerLimit': '78', 'upperLimit': '92'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HER2+ Trastuzumab/Doxorubicin/Paclitaxel/CMF (HER2+TC)', 'description': 'Participants with human epidermal growth factor receptor 2 proto-oncogene positive (HER2+) breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): trastuzumab 8 milligrams per kilogram (mg/kg), intravenously (IV) on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/square meter (mg/m\\^2), IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.\n\nCycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.'}, {'id': 'FG001', 'title': 'HER2+ Doxorubicin/Paclitaxel/CMF (HER2+C)', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}, {'id': 'FG002', 'title': 'HER2- Doxorubicin/Paclitaxel/CMF (HER2-C)', 'description': 'Participants with human epidermal growth factor receptor proto-oncogene negative (HER2-) breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '116'}, {'groupId': 'FG002', 'numSubjects': '99'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '114'}, {'groupId': 'FG002', 'numSubjects': '98'}]}], 'dropWithdraws': [{'type': 'Participants ongoing in follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '58'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Failure to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Violation of Selection Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Administrative/Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '326', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'HER2+ TC', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.\n\nCycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.'}, {'id': 'BG001', 'title': 'HER2+ C', 'description': 'Participants with HER2+ breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV and paclitaxel 150 mg/m\\^2, IV, on Day 1 followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}, {'id': 'BG002', 'title': 'HER2- C', 'description': 'Participants with HER2- breast cancer received treatment as follows:\n\nCycles 1-3 (3-week cycles): doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 4-7 (3-week cycles): paclitaxel 175 mg/m\\^2, IV, on Day 1, followed by 2 weeks off.\n\nCycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\\^2, IV, methotrexate 40 mg/m\\^2, IV, and 5-fluorouracil 600 mg/m\\^2, IV, on Days 1 and 8, followed by 1 week off.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.2', 'spread': '9.78', 'groupId': 'BG000'}, {'value': '52.3', 'spread': '10.97', 'groupId': 'BG001'}, {'value': '50.6', 'spread': '10.46', 'groupId': 'BG002'}, {'value': '51.0', 'spread': '10.42', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '326', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population: all participants who were randomized for the main study or registered for the observational parallel study and who received study medication at least once. Groups were analyzed as randomized/registered. Age was missing for 1 participant in the HER2+ TC treatment group.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 330}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-24', 'studyFirstSubmitDate': '2013-11-25', 'resultsFirstSubmitDate': '2014-07-18', 'studyFirstSubmitQcDate': '2013-11-25', 'lastUpdatePostDateStruct': {'date': '2014-10-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-24', 'studyFirstPostDateStruct': {'date': '2013-12-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-Free Survival (EFS) - Percentage of Participants With an Event', 'timeFrame': 'Baseline (BL), Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter', 'description': 'EFS was defined as the time between randomization and date of documented occurrence of disease recurrence or progression (local, regional, distant or contralateral) or death due to any cause.'}, {'measure': 'Event-Free Survival', 'timeFrame': 'BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter', 'description': 'The median time, in months, between randomization and date of documented occurrence of an EFS event.'}, {'measure': 'Percentage of Participants Event Free at 1 Year', 'timeFrame': 'BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter'}, {'measure': 'Percentage of Participants Event Free at 2 Years', 'timeFrame': 'BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter'}, {'measure': 'Percentage of Participants Event Free at 3 Years', 'timeFrame': 'BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Breast Pathological Complete Response (bpCR)', 'timeFrame': 'BL, Day 1 of Cycles 1-10 (pre-surgery)', 'description': 'bpCR was defined as an absence of any invasive cancer cell of the primary tumor at the time of major surgery after neoadjuvant chemotherapy with and without trastuzumab.'}, {'measure': 'Percentage of Participants With Total Pathological Complete Response (tpCR)', 'timeFrame': 'BL, Day 1 of Cycles 1-10 (pre-surgery)', 'description': 'tpCR was defined as a determination of bpCR and an absence of positive axillary nodes on pathology.'}, {'measure': 'Percentage of Participants Achieving Either Complete Response (CR) or Partial Response (PR) According to Modified Response Evaluation Criteria in Solid Tumors (RECIST) Criteria', 'timeFrame': 'BL, Presurgery: Day 1 of Cycles 1-10', 'description': 'Assessments were made based on objective tumor measurements of the lesions as recorded in the case report form. In inflammatory cancer, progressive disease (PD) was defined as progression of any of the 2 signs of breast edema and erythema. In non-inflammatory cancer, PD was concluded if either the investigator judged the participant as having progressed at any time prior to surgery, or there was at least a 20% increase in the sum of target lesions (TLs), any new lesion, or clear progression of any nontarget lesion (NTLs). Clear progression of any NTL was defined as at least a 20% increase in the sum of NTLs compared to BL. PR was defined as at least a 30% decrease from BL in the sum of the longest diameter of TLs. CR was defined as no PD as assessed by the investigator and complete disappearance of all lesions.'}, {'measure': 'Overall Survival (OS) - Percentage of Participants With an Event', 'timeFrame': 'BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter', 'description': 'OS was defined as the time from the date of randomization to the date of the death due to any cause.'}, {'measure': 'Overall Survival', 'timeFrame': 'BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter', 'description': 'OS was defined as the time from the date of randomization to the date of the death due to any cause.'}, {'measure': 'Percentage of Participants Surviving at 1 Year', 'timeFrame': 'BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter'}, {'measure': 'Percentage of Participants Surviving at 2 Years', 'timeFrame': 'BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter'}, {'measure': 'Percentage of Participants Surviving at 3 Years', 'timeFrame': 'BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study will assess the efficacy and safety of adding Herceptin to a paclitaxel-containing regimen followed by cyclophosphamide/methotrexate/fluorouracil (CMF) chemotherapy in women with locally advanced breast cancer and HER2/c-erbB-2 gene amplification. In a parallel observational study patients with HER2-negative disease will receive the same chemotherapy without Herceptin.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female patients, \\>=18 years of age, with locally advanced breast cancer.\n\nExclusion Criteria:\n\n* previous therapy for any invasive malignancy.'}, 'identificationModule': {'nctId': 'NCT01998906', 'briefTitle': 'A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Open-label Study of the Effect of Paclitaxel, Doxorubicin, and CMF Neoadjuvant Chemotherapy, With and Without Herceptin, on Tumor Response in Women With HER2-positive Breast Cancer', 'orgStudyIdInfo': {'id': 'MO16432'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HER-2+ Trastuzumab, Doxorubicin/Paclitaxel/CMF', 'description': 'Participants with HER2 proto-oncogene positive breast cancer (HER2+) were treated with trastuzumab 8 milligrams per kilogram (mg/kg), intravenous (IV), on Day 1 of Cycle 1, followed by 6 mg/kg, IV, on Day 1 of Cycle 2 to up a maximum of Cycle 17. Participants also received doxorubicin 60 mg/ square meter (m\\^2), IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1 of Cycles 1 through 3. Followed by paclitaxel 175 mg/m\\^2, IV, alone on Day 1 of Cycles 4 through 7. Participants also received CMF: cyclophosphamide 600 mg/m\\^2, IV; methotrexate 40 mg/m\\^2, IV; and 5-fluorouracil 600 mg/m\\^2, IV, on Day 1 of Cycles 8 through 10.', 'interventionNames': ['Drug: Trastuzumab', 'Drug: Doxorubicin', 'Drug: Paclitaxel', 'Drug: CMF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HER-2+ Doxorubicin/Paclitaxel/CMF', 'description': 'Participants with HER2 proto-oncogene positive breast cancer were treated with doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1 of Cycles 1 through 3. Followed by paclitaxel 175 mg/m\\^2, IV, alone on Day 1 of Cycles 4 through 7. Participants also received CMF on Day 1 of Cycle 8 through 10.', 'interventionNames': ['Drug: Doxorubicin', 'Drug: Paclitaxel', 'Drug: CMF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HER-2- Doxorubicin/Paclitaxel/CMF', 'description': 'Participants with HER2 proto-oncogene negative breast cancer were treated with doxorubicin 60 mg/m\\^2, IV, and paclitaxel 150 mg/m\\^2, IV, on Day 1 of Cycles 1 through 3. Followed by paclitaxel 175 mg/m\\^2, IV, alone on Day 1 of Cycles 4 through 7. Participants also received CMF on Day 1 of Cycle 8 through 10.', 'interventionNames': ['Drug: Doxorubicin', 'Drug: Paclitaxel', 'Drug: CMF']}], 'interventions': [{'name': 'Trastuzumab', 'type': 'DRUG', 'otherNames': ['Herceptin'], 'description': '8mg/kg IV on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycle 2 up a maximum of Cycle 17', 'armGroupLabels': ['HER-2+ Trastuzumab, Doxorubicin/Paclitaxel/CMF']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'description': '60 mg/m2 IV on Day 1 of Cycles 1 through 3', 'armGroupLabels': ['HER-2+ Doxorubicin/Paclitaxel/CMF', 'HER-2+ Trastuzumab, Doxorubicin/Paclitaxel/CMF', 'HER-2- Doxorubicin/Paclitaxel/CMF']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': '150 mg/m2 IV on Day 1 of Cycles 1 through 3, followed by 175 mg/m2 IV on Day 1 of Cycles 4 through 7', 'armGroupLabels': ['HER-2+ Doxorubicin/Paclitaxel/CMF', 'HER-2+ Trastuzumab, Doxorubicin/Paclitaxel/CMF', 'HER-2- Doxorubicin/Paclitaxel/CMF']}, {'name': 'CMF', 'type': 'DRUG', 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