Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT00045032
Status:
COMPLETED
Last Update Posted:
2017-04-27
First Post:
2002-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary 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'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'global-roche-genentech-trials@gene.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, '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': 'From Baseline until end of treatment (maximum up to 2 years) with the exception of cardiac/cardiovascular events, second primary malignancies, pregnancies, and Herceptin-related adverse events (maximum up to 10 years)', 'description': 'Analysis Population Description: Safety Population', 'eventGroups': [{'id': 'EG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided. After the release of initial study results, participants in the Observation Arm were allowed to cross over to receive adjuvant Herceptin prior to disease recurrence. As such, adverse events that occurred after crossover were not included in the safety analyses for this arm.', 'otherNumAtRisk': 1744, 'otherNumAffected': 1076, 'seriousNumAtRisk': 1744, 'seriousNumAffected': 143}, {'id': 'EG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.', 'otherNumAtRisk': 1682, 'otherNumAffected': 1389, 'seriousNumAtRisk': 1682, 'seriousNumAffected': 269}, {'id': 'EG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.', 'otherNumAtRisk': 1673, 'otherNumAffected': 1440, 'seriousNumAtRisk': 1673, 'seriousNumAffected': 344}], 'otherEvents': [{'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 127}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 72}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 84}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 155}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 180}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 134}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 157}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 77}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 99}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 102}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 119}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 84}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 99}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 128}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 198}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 246}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 101}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 116}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 145}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 95}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 142}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 187}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 269}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 84}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 152}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 225}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 246}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 106}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 146}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 137}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 69}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 91}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 70}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 92}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 88}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 104}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 97}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 107}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 89}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 201}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 250}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 88}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 80}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 96}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 75}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 116}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 147}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 83}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 116}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 83}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Onychoclasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 98}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 99}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 135}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 130}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 166}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 159}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 104}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 128}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 81}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 92}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'seriousEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 24}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1673, 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'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Skin mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Telangiectasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Toxic skin eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 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'numAtRisk': 1744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Aortic occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Microangiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Subclavian vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Vaginal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1682, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1673, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Disease-Free Survival (DFS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1693', 'groupId': 'OG000'}, {'value': '1693', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 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No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000'}, {'value': '7.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '0.44', 'ciUpperLimit': '0.67', 'estimateComment': 'HR for Herceptin 1-Year Arm versus Observation Arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until time of event (median of 1 year)', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an Independent Data Monitoring Committee (IDMC) in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With DFS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1693', 'groupId': 'OG000'}, {'value': '1694', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000'}, {'value': '7.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.000', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.43', 'ciLowerLimit': '0.34', 'ciUpperLimit': '0.53', 'estimateComment': 'HR for Herceptin 2-Year Arm versus Observation Arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until time of event (median of 1 year)', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint.'}, {'type': 'PRIMARY', 'title': 'DFS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1693', 'groupId': 'OG000'}, {'value': '1693', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.18', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '81'}, {'value': '85.80', 'groupId': 'OG001', 'lowerLimit': '83', 'upperLimit': '89'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 2', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95 percent (%) confidence interval (CI) were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint.'}, {'type': 'PRIMARY', 'title': 'DFS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1693', 'groupId': 'OG000'}, {'value': '1694', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.60', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '77'}, {'value': '87.50', 'groupId': 'OG001', 'lowerLimit': '85', 'upperLimit': '90'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 2', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With DFS Events Compared to Observation: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.6', 'groupId': 'OG000'}, {'value': '27.7', 'groupId': 'OG001'}, {'value': '27.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.67', 'ciUpperLimit': '0.86', 'estimateComment': 'HR for Herceptin 1-Year Arm versus Observation Arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.67', 'ciUpperLimit': '0.85', 'estimateComment': 'HR for Herceptin 2-Year Arm versus Observation Arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until time of event (median of 8 years)', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'PRIMARY', 'title': 'DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.2', 'groupId': 'OG000', 'lowerLimit': '73.1', 'upperLimit': '77.3'}, {'value': '81.3', 'groupId': 'OG001', 'lowerLimit': '79.4', 'upperLimit': '83.2'}, {'value': '83.5', 'groupId': 'OG002', 'lowerLimit': '81.7', 'upperLimit': '85.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 3', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'PRIMARY', 'title': 'DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000', 'lowerLimit': '67.8', 'upperLimit': '72.3'}, {'value': '75.9', 'groupId': 'OG001', 'lowerLimit': '73.8', 'upperLimit': '78.0'}, {'value': '76.5', 'groupId': 'OG002', 'lowerLimit': '74.4', 'upperLimit': '78.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 5', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'PRIMARY', 'title': 'DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.0', 'groupId': 'OG000', 'lowerLimit': '63.6', 'upperLimit': '68.3'}, {'value': '72.4', 'groupId': 'OG001', 'lowerLimit': '70.2', 'upperLimit': '74.6'}, {'value': '72.5', 'groupId': 'OG002', 'lowerLimit': '70.4', 'upperLimit': '74.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 7', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'PRIMARY', 'title': 'DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.8', 'groupId': 'OG000', 'lowerLimit': '62.4', 'upperLimit': '67.2'}, {'value': '71.2', 'groupId': 'OG001', 'lowerLimit': '69.0', 'upperLimit': '73.4'}, {'value': '71.0', 'groupId': 'OG002', 'lowerLimit': '68.7', 'upperLimit': '73.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 8', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With DFS Events Compared to Observation: 10-Year Maximum Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.8', 'groupId': 'OG000'}, {'value': '29.7', 'groupId': 'OG001'}, {'value': '30.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.68', 'ciUpperLimit': '0.86', 'estimateComment': 'HR for Herceptin 1-Year Arm versus Observation Arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.69', 'ciUpperLimit': '0.87', 'estimateComment': 'HR for Herceptin 2-Year Arm versus Observation Arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until time of event (maximum of 10 years)', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'PRIMARY', 'title': 'DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.2', 'groupId': 'OG000', 'lowerLimit': '73.1', 'upperLimit': '77.3'}, {'value': '81.3', 'groupId': 'OG001', 'lowerLimit': '79.4', 'upperLimit': '83.2'}, {'value': '83.4', 'groupId': 'OG002', 'lowerLimit': '81.6', 'upperLimit': '85.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 3', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'PRIMARY', 'title': 'DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000', 'lowerLimit': '67.8', 'upperLimit': '72.2'}, {'value': '75.9', 'groupId': 'OG001', 'lowerLimit': '73.8', 'upperLimit': '78.0'}, {'value': '76.4', 'groupId': 'OG002', 'lowerLimit': '74.4', 'upperLimit': '78.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 5', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'PRIMARY', 'title': 'DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.8', 'groupId': 'OG000', 'lowerLimit': '63.5', 'upperLimit': '68.2'}, {'value': '72.4', 'groupId': 'OG001', 'lowerLimit': '70.2', 'upperLimit': '74.5'}, {'value': '72.5', 'groupId': 'OG002', 'lowerLimit': '70.3', 'upperLimit': '74.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 7', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'PRIMARY', 'title': 'DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.7', 'groupId': 'OG000', 'lowerLimit': '62.3', 'upperLimit': '67.0'}, {'value': '71.2', 'groupId': 'OG001', 'lowerLimit': '69.0', 'upperLimit': '73.4'}, {'value': '70.7', 'groupId': 'OG002', 'lowerLimit': '68.5', 'upperLimit': '72.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 8', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'PRIMARY', 'title': 'DFS Rate at Year 9 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.5', 'groupId': 'OG000', 'lowerLimit': '61.2', 'upperLimit': '65.9'}, {'value': '70.3', 'groupId': 'OG001', 'lowerLimit': '68.1', 'upperLimit': '72.6'}, {'value': '69.2', 'groupId': 'OG002', 'lowerLimit': '67.0', 'upperLimit': '71.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 9', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'PRIMARY', 'title': 'DFS Rate at Year 10 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '60.1', 'upperLimit': '64.8'}, {'value': '69.3', 'groupId': 'OG001', 'lowerLimit': '67.0', 'upperLimit': '71.5'}, {'value': '68.5', 'groupId': 'OG002', 'lowerLimit': '66.2', 'upperLimit': '70.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 10', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DFS Events in 1-Year Versus 2-Year Herceptin: 10-Year Maximum Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1552', 'groupId': 'OG000'}, {'value': '1553', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG001', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.8', 'groupId': 'OG000'}, {'value': '26.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7962', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.17', 'estimateComment': 'HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until time of event (maximum of 10 years)', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population 1-Year Herceptin Versus 2-Year Herceptin (1Y2Y): Participants without a DFS event and still under follow-up at the pre-defined landmark of 366 days after randomization, analyzed when intent-to-treat principle was applied for comparison of 1 year versus 2 years of Herceptin.'}, {'type': 'SECONDARY', 'title': 'DFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 10-Year Maximum Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1552', 'groupId': 'OG000'}, {'value': '1553', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG001', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'title': 'Year 3', 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000', 'lowerLimit': '85.0', 'upperLimit': '88.4'}, {'value': '89.0', 'groupId': 'OG001', 'lowerLimit': '87.4', 'upperLimit': '90.6'}]}]}, {'title': 'Year 5', 'categories': [{'measurements': [{'value': '81.0', 'groupId': 'OG000', 'lowerLimit': '79.0', 'upperLimit': '82.9'}, {'value': '81.6', 'groupId': 'OG001', 'lowerLimit': '79.6', 'upperLimit': '83.5'}]}]}, {'title': 'Year 7', 'categories': [{'measurements': [{'value': '77.2', 'groupId': 'OG000', 'lowerLimit': '75.1', 'upperLimit': '79.3'}, {'value': '77.4', 'groupId': 'OG001', 'lowerLimit': '75.3', 'upperLimit': '79.5'}]}]}, {'title': 'Year 8', 'categories': [{'measurements': [{'value': '75.9', 'groupId': 'OG000', 'lowerLimit': '73.8', 'upperLimit': '78.1'}, {'value': '75.5', 'groupId': 'OG001', 'lowerLimit': '73.3', 'upperLimit': '77.7'}]}]}, {'title': 'Year 9', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '72.8', 'upperLimit': '77.2'}, {'value': '73.9', 'groupId': 'OG001', 'lowerLimit': '71.7', 'upperLimit': '76.1'}]}]}, {'title': 'Year 10', 'categories': [{'measurements': [{'value': '73.9', 'groupId': 'OG000', 'lowerLimit': '71.7', 'upperLimit': '76.1'}, {'value': '73.1', 'groupId': 'OG001', 'lowerLimit': '70.8', 'upperLimit': '75.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Years 3, 5, 7, 8, 9, 10', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population 1Y2Y'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Overall Survival (OS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1693', 'groupId': 'OG000'}, {'value': '1693', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2379', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.47', 'ciUpperLimit': '1.21', 'estimateComment': 'HR for Herceptin 1-Year Arm versus Observation Arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until time of event (median of 1 year)', 'description': 'OS events referred to death from any cause. The percentage of participants who died was reported. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With OS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1693', 'groupId': 'OG000'}, {'value': '1694', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '0.28', 'ciUpperLimit': '0.79', 'estimateComment': 'HR for Herceptin 2-Year Arm versus Observation Arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until time of event (median of 1 year)', 'description': 'OS events referred to death from any cause. The percentage of participants who died was reported. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint.'}, {'type': 'SECONDARY', 'title': 'OS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1693', 'groupId': 'OG000'}, {'value': '1693', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.98', 'groupId': 'OG000', 'lowerLimit': '93', 'upperLimit': '97'}, {'value': '95.88', 'groupId': 'OG001', 'lowerLimit': '94', 'upperLimit': '98'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 2', 'description': 'OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint.'}, {'type': 'SECONDARY', 'title': 'OS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1693', 'groupId': 'OG000'}, {'value': '1694', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.39', 'groupId': 'OG000', 'lowerLimit': '92', 'upperLimit': '97'}, {'value': '97.28', 'groupId': 'OG001', 'lowerLimit': '96', 'upperLimit': '98'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 2', 'description': 'OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With OS Events Compared to Observation: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000'}, {'value': '16.3', 'groupId': 'OG001'}, {'value': '16.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.65', 'ciUpperLimit': '0.88', 'estimateComment': 'HR for Herceptin 1-Year Arm versus Observation Arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.63', 'ciUpperLimit': '0.86', 'estimateComment': 'HR for Herceptin 2-Year Arm versus Observation Arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until time of event (median of 8 years)', 'description': 'OS events referred to death from any cause. The percentage of participants who died was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'SECONDARY', 'title': 'OS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'title': 'Year 3', 'categories': [{'measurements': [{'value': '90.7', 'groupId': 'OG000', 'lowerLimit': '89.3', 'upperLimit': '92.1'}, {'value': '92.7', 'groupId': 'OG001', 'lowerLimit': '91.5', 'upperLimit': '94.0'}, {'value': '94.4', 'groupId': 'OG002', 'lowerLimit': '93.3', 'upperLimit': '95.6'}]}]}, {'title': 'Year 5', 'categories': [{'measurements': [{'value': '84.5', 'groupId': 'OG000', 'lowerLimit': '82.8', 'upperLimit': '86.3'}, {'value': '86.9', 'groupId': 'OG001', 'lowerLimit': '85.2', 'upperLimit': '88.5'}, {'value': '88.7', 'groupId': 'OG002', 'lowerLimit': '87.2', 'upperLimit': '90.3'}]}]}, {'title': 'Year 7', 'categories': [{'measurements': [{'value': '79.5', 'groupId': 'OG000', 'lowerLimit': '77.5', 'upperLimit': '81.5'}, {'value': '83.9', 'groupId': 'OG001', 'lowerLimit': '82.1', 'upperLimit': '85.7'}, {'value': '84.6', 'groupId': 'OG002', 'lowerLimit': '82.9', 'upperLimit': '86.4'}]}]}, {'title': 'Year 8', 'categories': [{'measurements': [{'value': '77.4', 'groupId': 'OG000', 'lowerLimit': '75.2', 'upperLimit': '79.5'}, {'value': '82.7', 'groupId': 'OG001', 'lowerLimit': '80.8', 'upperLimit': '84.6'}, {'value': '82.4', 'groupId': 'OG002', 'lowerLimit': '80.4', 'upperLimit': '84.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Years 3, 5, 7, 8', 'description': 'OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With OS Events Compared to Observation: 11-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000'}, {'value': '18.8', 'groupId': 'OG001'}, {'value': '18.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.64', 'ciUpperLimit': '0.86', 'estimateComment': 'HR for Herceptin 1-Year Arm versus Observation Arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.62', 'ciUpperLimit': '0.83', 'estimateComment': 'HR for Herceptin 2-Year Arm versus Observation Arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until time of event (median of 11 years)', 'description': 'OS events referred to death from any cause. The percentage of participants who died was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'SECONDARY', 'title': 'OS Rate According to Kaplan-Meier Analysis Compared to Observation: 11-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'title': 'Year 3', 'categories': [{'measurements': [{'value': '90.7', 'groupId': 'OG000', 'lowerLimit': '89.3', 'upperLimit': '92.1'}, {'value': '92.7', 'groupId': 'OG001', 'lowerLimit': '91.5', 'upperLimit': '94.0'}, {'value': '94.4', 'groupId': 'OG002', 'lowerLimit': '93.3', 'upperLimit': '95.6'}]}]}, {'title': 'Year 5', 'categories': [{'measurements': [{'value': '84.5', 'groupId': 'OG000', 'lowerLimit': '82.8', 'upperLimit': '86.3'}, {'value': '86.9', 'groupId': 'OG001', 'lowerLimit': '85.2', 'upperLimit': '88.5'}, {'value': '88.7', 'groupId': 'OG002', 'lowerLimit': '87.2', 'upperLimit': '90.3'}]}]}, {'title': 'Year 7', 'categories': [{'measurements': [{'value': '79.4', 'groupId': 'OG000', 'lowerLimit': '77.4', 'upperLimit': '81.4'}, {'value': '83.8', 'groupId': 'OG001', 'lowerLimit': '82.0', 'upperLimit': '85.6'}, {'value': '84.7', 'groupId': 'OG002', 'lowerLimit': '82.9', 'upperLimit': '86.4'}]}]}, {'title': 'Year 9', 'categories': [{'measurements': [{'value': '76.5', 'groupId': 'OG000', 'lowerLimit': '74.4', 'upperLimit': '78.6'}, {'value': '81.9', 'groupId': 'OG001', 'lowerLimit': '80.0', 'upperLimit': '83.8'}, {'value': '81.8', 'groupId': 'OG002', 'lowerLimit': '80.0', 'upperLimit': '83.7'}]}]}, {'title': 'Year 10', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '72.9', 'upperLimit': '77.2'}, {'value': '80.7', 'groupId': 'OG001', 'lowerLimit': '78.8', 'upperLimit': '82.6'}, {'value': '81.0', 'groupId': 'OG002', 'lowerLimit': '79.0', 'upperLimit': '82.9'}]}]}, {'title': 'Year 11', 'categories': [{'measurements': [{'value': '73.7', 'groupId': 'OG000', 'lowerLimit': '71.5', 'upperLimit': '76.0'}, {'value': '80.0', 'groupId': 'OG001', 'lowerLimit': '78.1', 'upperLimit': '82.0'}, {'value': '80.3', 'groupId': 'OG002', 'lowerLimit': '78.3', 'upperLimit': '82.3'}]}]}, {'title': 'Year 12', 'categories': [{'measurements': [{'value': '72.9', 'groupId': 'OG000', 'lowerLimit': '70.4', 'upperLimit': '75.3'}, {'value': '79.4', 'groupId': 'OG001', 'lowerLimit': '77.3', 'upperLimit': '81.5'}, {'value': '79.5', 'groupId': 'OG002', 'lowerLimit': '77.4', 'upperLimit': '81.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Years 3, 5, 7, 9, 10, 11, 12', 'description': 'OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with an 11-year median follow-up for OS events.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With OS Events in 1-Year Versus 2-Year Herceptin: 11-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1552', 'groupId': 'OG000'}, {'value': '1553', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG001', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000'}, {'value': '14.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9156', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.21', 'estimateComment': 'HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until time of event (median of 11 years)', 'description': 'OS events referred to death from any cause. The percentage of participants who died was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population 1Y2Y'}, {'type': 'SECONDARY', 'title': 'OS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 11-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1552', 'groupId': 'OG000'}, {'value': '1553', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG001', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'title': 'Year 3', 'categories': [{'measurements': [{'value': '96.5', 'groupId': 'OG000', 'lowerLimit': '95.6', 'upperLimit': '97.4'}, {'value': '97.4', 'groupId': 'OG001', 'lowerLimit': '96.6', 'upperLimit': '98.2'}]}]}, {'title': 'Year 5', 'categories': [{'measurements': [{'value': '91.4', 'groupId': 'OG000', 'lowerLimit': '90.0', 'upperLimit': '92.8'}, {'value': '92.6', 'groupId': 'OG001', 'lowerLimit': '91.2', 'upperLimit': '93.9'}]}]}, {'title': 'Year 7', 'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000', 'lowerLimit': '87.0', 'upperLimit': '90.2'}, {'value': '88.7', 'groupId': 'OG001', 'lowerLimit': '87.1', 'upperLimit': '90.3'}]}]}, {'title': 'Year 9', 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000', 'lowerLimit': '85.0', 'upperLimit': '88.5'}, {'value': '85.9', 'groupId': 'OG001', 'lowerLimit': '84.2', 'upperLimit': '87.7'}]}]}, {'title': 'Year 10', 'categories': [{'measurements': [{'value': '85.4', 'groupId': 'OG000', 'lowerLimit': '83.6', 'upperLimit': '87.2'}, {'value': '85.1', 'groupId': 'OG001', 'lowerLimit': '83.3', 'upperLimit': '86.9'}]}]}, {'title': 'Year 11', 'categories': [{'measurements': [{'value': '84.7', 'groupId': 'OG000', 'lowerLimit': '82.9', 'upperLimit': '86.6'}, {'value': '84.4', 'groupId': 'OG001', 'lowerLimit': '82.5', 'upperLimit': '86.2'}]}]}, {'title': 'Year 12', 'categories': [{'measurements': [{'value': '84.1', 'groupId': 'OG000', 'lowerLimit': '82.1', 'upperLimit': '86.1'}, {'value': '83.6', 'groupId': 'OG001', 'lowerLimit': '81.5', 'upperLimit': '85.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Years 3, 5, 7, 9, 10, 11, 12', 'description': 'OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with an 11-year median follow-up for OS events.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population 1Y2Y'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Recurrence-Free Survival (RFS) Events Compared to Observation: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.8', 'groupId': 'OG000'}, {'value': '23.4', 'groupId': 'OG001'}, {'value': '22.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.64', 'ciUpperLimit': '0.83', 'estimateComment': 'HR for Herceptin 1-Year Arm versus Observation Arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.61', 'ciUpperLimit': '0.79', 'estimateComment': 'HR for Herceptin 2-Year Arm versus Observation Arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until time of event (median of 8 years)', 'description': 'RFS events included local, regional, or distant tumor recurrence. The percentage of participants with at least one RFS event was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'SECONDARY', 'title': 'RFS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'title': 'Year 3', 'categories': [{'measurements': [{'value': '76.4', 'groupId': 'OG000', 'lowerLimit': '74.3', 'upperLimit': '78.4'}, {'value': '82.7', 'groupId': 'OG001', 'lowerLimit': '80.9', 'upperLimit': '84.6'}, {'value': '86.0', 'groupId': 'OG002', 'lowerLimit': '84.3', 'upperLimit': '87.6'}]}]}, {'title': 'Year 5', 'categories': [{'measurements': [{'value': '71.9', 'groupId': 'OG000', 'lowerLimit': '69.7', 'upperLimit': '74.1'}, {'value': '78.4', 'groupId': 'OG001', 'lowerLimit': '76.4', 'upperLimit': '80.4'}, {'value': '79.9', 'groupId': 'OG002', 'lowerLimit': '77.9', 'upperLimit': '81.9'}]}]}, {'title': 'Year 7', 'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000', 'lowerLimit': '66.7', 'upperLimit': '71.3'}, {'value': '75.7', 'groupId': 'OG001', 'lowerLimit': '73.6', 'upperLimit': '77.8'}, {'value': '76.7', 'groupId': 'OG002', 'lowerLimit': '74.6', 'upperLimit': '78.8'}]}]}, {'title': 'Year 8', 'categories': [{'measurements': [{'value': '68.4', 'groupId': 'OG000', 'lowerLimit': '66.1', 'upperLimit': '70.7'}, {'value': '75.1', 'groupId': 'OG001', 'lowerLimit': '72.9', 'upperLimit': '77.2'}, {'value': '75.8', 'groupId': 'OG002', 'lowerLimit': '73.6', 'upperLimit': '77.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Years 3, 5, 7, 8', 'description': 'RFS events included local, regional, or distant tumor recurrence. The percentage of participants free of RFS events (i.e., the RFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With RFS Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1552', 'groupId': 'OG000'}, {'value': '1553', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG001', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}, {'value': '18.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4755', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.11', 'estimateComment': 'HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until time of event (median of 8 years)', 'description': 'RFS events included local, regional, or distant tumor recurrence. The percentage of participants with at least one RFS event was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population 1Y2Y'}, {'type': 'SECONDARY', 'title': 'RFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1552', 'groupId': 'OG000'}, {'value': '1553', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG001', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'title': 'Year 3', 'categories': [{'measurements': [{'value': '87.7', 'groupId': 'OG000', 'lowerLimit': '86.0', 'upperLimit': '89.3'}, {'value': '90.9', 'groupId': 'OG001', 'lowerLimit': '89.4', 'upperLimit': '92.3'}]}]}, {'title': 'Year 5', 'categories': [{'measurements': [{'value': '83.1', 'groupId': 'OG000', 'lowerLimit': '81.2', 'upperLimit': '85.0'}, {'value': '84.5', 'groupId': 'OG001', 'lowerLimit': '82.7', 'upperLimit': '86.4'}]}]}, {'title': 'Year 7', 'categories': [{'measurements': [{'value': '80.2', 'groupId': 'OG000', 'lowerLimit': '78.2', 'upperLimit': '82.3'}, {'value': '81.3', 'groupId': 'OG001', 'lowerLimit': '79.3', 'upperLimit': '83.2'}]}]}, {'title': 'Year 8', 'categories': [{'measurements': [{'value': '79.6', 'groupId': 'OG000', 'lowerLimit': '77.5', 'upperLimit': '81.6'}, {'value': '80.3', 'groupId': 'OG001', 'lowerLimit': '78.2', 'upperLimit': '82.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Years 3, 5, 7, 8', 'description': 'RFS events included local, regional, or distant tumor recurrence. The percentage of participants free of RFS events (i.e., the RFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population 1Y2Y'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Distant Disease-Free Survival (DDFS) Events Compared to Observation: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000'}, {'value': '23.4', 'groupId': 'OG001'}, {'value': '23.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.67', 'ciUpperLimit': '0.87', 'estimateComment': 'HR for Herceptin 1-Year Arm versus Observation Arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.65', 'ciUpperLimit': '0.85', 'estimateComment': 'HR for Herceptin 2-Year Arm versus Observation Arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until time of event (median of 8 years)', 'description': 'DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants with at least one DDFS event was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'SECONDARY', 'title': 'DDFS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'title': 'Year 3', 'categories': [{'measurements': [{'value': '78.6', 'groupId': 'OG000', 'lowerLimit': '76.6', 'upperLimit': '80.6'}, {'value': '84.4', 'groupId': 'OG001', 'lowerLimit': '82.7', 'upperLimit': '86.2'}, {'value': '85.9', 'groupId': 'OG002', 'lowerLimit': '84.2', 'upperLimit': '87.6'}]}]}, {'title': 'Year 5', 'categories': [{'measurements': [{'value': '74.2', 'groupId': 'OG000', 'lowerLimit': '72.1', 'upperLimit': '76.4'}, {'value': '79.6', 'groupId': 'OG001', 'lowerLimit': '77.6', 'upperLimit': '81.6'}, {'value': '80.2', 'groupId': 'OG002', 'lowerLimit': '78.2', 'upperLimit': '82.1'}]}]}, {'title': 'Year 7', 'categories': [{'measurements': [{'value': '70.8', 'groupId': 'OG000', 'lowerLimit': '68.6', 'upperLimit': '73.1'}, {'value': '76.7', 'groupId': 'OG001', 'lowerLimit': '74.6', 'upperLimit': '78.8'}, {'value': '76.7', 'groupId': 'OG002', 'lowerLimit': '74.6', 'upperLimit': '78.8'}]}]}, {'title': 'Year 8', 'categories': [{'measurements': [{'value': '69.6', 'groupId': 'OG000', 'lowerLimit': '67.3', 'upperLimit': '71.9'}, {'value': '75.5', 'groupId': 'OG001', 'lowerLimit': '73.4', 'upperLimit': '77.6'}, {'value': '75.6', 'groupId': 'OG002', 'lowerLimit': '73.4', 'upperLimit': '77.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Years 3, 5, 7, 8', 'description': 'DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants free of DDFS events (i.e., the DDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DDFS Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1552', 'groupId': 'OG000'}, {'value': '1553', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG001', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000'}, {'value': '19.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9626', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.17', 'estimateComment': 'HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until time of event (median of 8 years)', 'description': 'DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants with at least one DDFS event was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population 1Y2Y'}, {'type': 'SECONDARY', 'title': 'DDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1552', 'groupId': 'OG000'}, {'value': '1553', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG001', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'title': 'Year 3', 'categories': [{'measurements': [{'value': '89.4', 'groupId': 'OG000', 'lowerLimit': '87.9', 'upperLimit': '91.0'}, {'value': '90.8', 'groupId': 'OG001', 'lowerLimit': '89.4', 'upperLimit': '92.2'}]}]}, {'title': 'Year 5', 'categories': [{'measurements': [{'value': '84.5', 'groupId': 'OG000', 'lowerLimit': '82.7', 'upperLimit': '86.3'}, {'value': '84.7', 'groupId': 'OG001', 'lowerLimit': '82.9', 'upperLimit': '86.5'}]}]}, {'title': 'Year 7', 'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG000', 'lowerLimit': '79.5', 'upperLimit': '83.4'}, {'value': '81.1', 'groupId': 'OG001', 'lowerLimit': '79.1', 'upperLimit': '83.1'}]}]}, {'title': 'Year 8', 'categories': [{'measurements': [{'value': '80.1', 'groupId': 'OG000', 'lowerLimit': '78.1', 'upperLimit': '82.2'}, {'value': '79.9', 'groupId': 'OG001', 'lowerLimit': '77.8', 'upperLimit': '81.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Years 3, 5, 7, 8', 'description': 'DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants free of DDFS events (i.e., the DDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population 1Y2Y'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Tumor Recurrence (TR) Compared to Observation: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.8', 'groupId': 'OG000'}, {'value': '23.4', 'groupId': 'OG001'}, {'value': '22.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.64', 'ciUpperLimit': '0.83', 'estimateComment': 'HR for Herceptin 1-Year Arm versus Observation Arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.61', 'ciUpperLimit': '0.79', 'estimateComment': 'HR for Herceptin 2-Year Arm versus Observation Arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until time of event (median of 8 years)', 'description': 'The percentage of participants with TR of the present breast cancer was reported. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'SECONDARY', 'title': 'TR-Free Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'title': 'Year 3', 'categories': [{'measurements': [{'value': '76.5', 'groupId': 'OG000', 'lowerLimit': '74.4', 'upperLimit': '78.5'}, {'value': '82.8', 'groupId': 'OG001', 'lowerLimit': '81.0', 'upperLimit': '84.6'}, {'value': '86.1', 'groupId': 'OG002', 'lowerLimit': '84.4', 'upperLimit': '87.7'}]}]}, {'title': 'Year 5', 'categories': [{'measurements': [{'value': '72.1', 'groupId': 'OG000', 'lowerLimit': '69.9', 'upperLimit': '74.3'}, {'value': '78.6', 'groupId': 'OG001', 'lowerLimit': '76.6', 'upperLimit': '80.6'}, {'value': '80.1', 'groupId': 'OG002', 'lowerLimit': '78.2', 'upperLimit': '82.1'}]}]}, {'title': 'Year 7', 'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000', 'lowerLimit': '67.0', 'upperLimit': '71.5'}, {'value': '75.9', 'groupId': 'OG001', 'lowerLimit': '73.9', 'upperLimit': '78.0'}, {'value': '77.0', 'groupId': 'OG002', 'lowerLimit': '75.0', 'upperLimit': '79.1'}]}]}, {'title': 'Year 8', 'categories': [{'measurements': [{'value': '68.6', 'groupId': 'OG000', 'lowerLimit': '66.4', 'upperLimit': '70.9'}, {'value': '75.3', 'groupId': 'OG001', 'lowerLimit': '73.2', 'upperLimit': '77.4'}, {'value': '76.2', 'groupId': 'OG002', 'lowerLimit': '74.1', 'upperLimit': '78.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Years 3, 5, 7, 8', 'description': 'The percentage of participants without TR of the present breast cancer (i.e., the TR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With TR in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1552', 'groupId': 'OG000'}, {'value': '1553', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG001', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}, {'value': '18.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4500', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.10', 'estimateComment': 'HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until time of event (median of 8 years)', 'description': 'The percentage of participants with TR of the present breast cancer was reported. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population 1Y2Y'}, {'type': 'SECONDARY', 'title': 'TR-Free Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1552', 'groupId': 'OG000'}, {'value': '1553', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG001', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'title': 'Year 3', 'categories': [{'measurements': [{'value': '87.7', 'groupId': 'OG000', 'lowerLimit': '86.1', 'upperLimit': '89.4'}, {'value': '90.9', 'groupId': 'OG001', 'lowerLimit': '89.5', 'upperLimit': '92.4'}]}]}, {'title': 'Year 5', 'categories': [{'measurements': [{'value': '83.2', 'groupId': 'OG000', 'lowerLimit': '81.3', 'upperLimit': '85.1'}, {'value': '84.7', 'groupId': 'OG001', 'lowerLimit': '82.9', 'upperLimit': '86.5'}]}]}, {'title': 'Year 7', 'categories': [{'measurements': [{'value': '80.4', 'groupId': 'OG000', 'lowerLimit': '78.4', 'upperLimit': '82.4'}, {'value': '81.5', 'groupId': 'OG001', 'lowerLimit': '79.6', 'upperLimit': '83.5'}]}]}, {'title': 'Year 8', 'categories': [{'measurements': [{'value': '79.8', 'groupId': 'OG000', 'lowerLimit': '77.7', 'upperLimit': '81.8'}, {'value': '80.6', 'groupId': 'OG001', 'lowerLimit': '78.6', 'upperLimit': '82.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Years 3, 5, 7, 8', 'description': 'The percentage of participants without TR of the present breast cancer (i.e., the TR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population 1Y2Y'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Distant Tumor Recurrence (DTR) Compared to Observation: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.3', 'groupId': 'OG000'}, {'value': '19.4', 'groupId': 'OG001'}, {'value': '18.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.62', 'ciUpperLimit': '0.83', 'estimateComment': 'HR for Herceptin 1-Year Arm versus Observation Arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.59', 'ciUpperLimit': '0.79', 'estimateComment': 'HR for Herceptin 2-Year Arm versus Observation Arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until time of event (median of 8 years)', 'description': 'The percentage of participants with DTR was reported. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'SECONDARY', 'title': 'DTR-Free Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'OG000'}, {'value': '1702', 'groupId': 'OG001'}, {'value': '1700', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'title': 'Year 3', 'categories': [{'measurements': [{'value': '79.8', 'groupId': 'OG000', 'lowerLimit': '77.8', 'upperLimit': '81.7'}, {'value': '85.9', 'groupId': 'OG001', 'lowerLimit': '84.2', 'upperLimit': '87.6'}, {'value': '88.1', 'groupId': 'OG002', 'lowerLimit': '86.5', 'upperLimit': '89.6'}]}]}, {'title': 'Year 5', 'categories': [{'measurements': [{'value': '76.5', 'groupId': 'OG000', 'lowerLimit': '74.4', 'upperLimit': '78.5'}, {'value': '82.1', 'groupId': 'OG001', 'lowerLimit': '80.2', 'upperLimit': '84.0'}, {'value': '83.4', 'groupId': 'OG002', 'lowerLimit': '81.5', 'upperLimit': '85.2'}]}]}, {'title': 'Year 7', 'categories': [{'measurements': [{'value': '74.0', 'groupId': 'OG000', 'lowerLimit': '71.8', 'upperLimit': '76.1'}, {'value': '80.1', 'groupId': 'OG001', 'lowerLimit': '78.2', 'upperLimit': '82.1'}, {'value': '80.7', 'groupId': 'OG002', 'lowerLimit': '78.8', 'upperLimit': '82.6'}]}]}, {'title': 'Year 8', 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000', 'lowerLimit': '71.1', 'upperLimit': '75.5'}, {'value': '79.5', 'groupId': 'OG001', 'lowerLimit': '77.5', 'upperLimit': '81.5'}, {'value': '80.3', 'groupId': 'OG002', 'lowerLimit': '78.3', 'upperLimit': '82.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Years 3, 5, 7, 8', 'description': 'The percentage of participants without DTR (i.e., the DTR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DTR in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1552', 'groupId': 'OG000'}, {'value': '1553', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG001', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000'}, {'value': '15.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6823', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.15', 'estimateComment': 'HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until time of event (median of 8 years)', 'description': 'The percentage of participants with DTR was reported. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population 1Y2Y'}, {'type': 'SECONDARY', 'title': 'DTR-Free Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1552', 'groupId': 'OG000'}, {'value': '1553', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG001', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'title': 'Year 3', 'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000', 'lowerLimit': '89.0', 'upperLimit': '91.9'}, {'value': '92.4', 'groupId': 'OG001', 'lowerLimit': '91.1', 'upperLimit': '93.8'}]}]}, {'title': 'Year 5', 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000', 'lowerLimit': '85.0', 'upperLimit': '88.4'}, {'value': '87.5', 'groupId': 'OG001', 'lowerLimit': '85.8', 'upperLimit': '89.2'}]}]}, {'title': 'Year 7', 'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000', 'lowerLimit': '82.8', 'upperLimit': '86.4'}, {'value': '84.9', 'groupId': 'OG001', 'lowerLimit': '83.1', 'upperLimit': '86.7'}]}]}, {'title': 'Year 8', 'categories': [{'measurements': [{'value': '83.9', 'groupId': 'OG000', 'lowerLimit': '82.1', 'upperLimit': '85.8'}, {'value': '84.4', 'groupId': 'OG001', 'lowerLimit': '82.6', 'upperLimit': '86.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Years 3, 5, 7, 8', 'description': 'The percentage of participants without DTR (i.e., the DTR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population 1Y2Y'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Restricted Disease-Free Survival (RDFS) Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1552', 'groupId': 'OG000'}, {'value': '1553', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG001', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000'}, {'value': '21.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7251', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.13', 'estimateComment': 'HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until time of event (median of 8 years)', 'description': 'RDFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer, or death from any cause. The percentage of participants with at least one RDFS event was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population 1Y2Y. In contrast to other study endpoints, RDFS compared to the Observation Arm was not a planned endpoint according to study protocol. Only RDFS in Herceptin 1-Year Arm versus Herceptin 2-Year Arm was a planned endpoint.'}, {'type': 'SECONDARY', 'title': 'RDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1552', 'groupId': 'OG000'}, {'value': '1553', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG001', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'title': 'Year 3', 'categories': [{'measurements': [{'value': '87.3', 'groupId': 'OG000', 'lowerLimit': '85.6', 'upperLimit': '89.0'}, {'value': '89.9', 'groupId': 'OG001', 'lowerLimit': '88.4', 'upperLimit': '91.4'}]}]}, {'title': 'Year 5', 'categories': [{'measurements': [{'value': '81.9', 'groupId': 'OG000', 'lowerLimit': '79.9', 'upperLimit': '83.8'}, {'value': '83.0', 'groupId': 'OG001', 'lowerLimit': '81.1', 'upperLimit': '84.9'}]}]}, {'title': 'Year 7', 'categories': [{'measurements': [{'value': '78.5', 'groupId': 'OG000', 'lowerLimit': '76.4', 'upperLimit': '80.6'}, {'value': '78.9', 'groupId': 'OG001', 'lowerLimit': '76.9', 'upperLimit': '81.0'}]}]}, {'title': 'Year 8', 'categories': [{'measurements': [{'value': '77.2', 'groupId': 'OG000', 'lowerLimit': '75.1', 'upperLimit': '79.3'}, {'value': '77.7', 'groupId': 'OG001', 'lowerLimit': '75.5', 'upperLimit': '79.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Years 3, 5, 7, 8', 'description': 'RDFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer, or death from any cause. The percentage of participants free of RDFS events (i.e., the RDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population 1Y2Y. In contrast to other study endpoints, RDFS compared to the Observation Arm was not a planned endpoint according to study protocol. Only RDFS in Herceptin 1-Year Arm versus Herceptin 2-Year Arm was a planned endpoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Primary Cardiac Endpoint Events Compared to Observation: 10-Year Maximum Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1744', 'groupId': 'OG000'}, {'value': '1682', 'groupId': 'OG001'}, {'value': '1673', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.41'}, {'value': '1.07', 'groupId': 'OG001', 'lowerLimit': '0.64', 'upperLimit': '1.69'}, {'value': '1.02', 'groupId': 'OG002', 'lowerLimit': '0.59', 'upperLimit': '1.62'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until time of event (maximum up to 10 years)', 'description': 'Primary cardiac endpoint events included the occurrence of any of the following between randomization and new therapy for recurrent disease: symptomatic New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF) confirmed by a cardiologist with a drop in left ventricular ejection fraction (LVEF) at least 10 percentage points from Baseline and to a value less than (\\<) 50%, and documentation of definite or probable cardiac death. Definite cardiac death included CHF, myocardial infarction, or primary arrhythmia. Probable cardiac death included unexpected sudden death within 24 hours of a cardiac event (syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology. The percentage of participants with at least one primary cardiac endpoint event was reported. The 95% CI was calculated by the Pearson-Clopper method for a one-sample binomial.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: All participants randomized/enrolled in the study according to actual treatment received. Hence, participants assigned to Herceptin who received no study treatment were analyzed in the Observation Arm.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Secondary Cardiac Endpoint Events Compared to Observation: 10-Year Maximum Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1744', 'groupId': 'OG000'}, {'value': '1682', 'groupId': 'OG001'}, {'value': '1673', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'OG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'OG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.86', 'groupId': 'OG000', 'lowerLimit': '0.48', 'upperLimit': '1.41'}, {'value': '4.40', 'groupId': 'OG001', 'lowerLimit': '3.47', 'upperLimit': '5.49'}, {'value': '7.29', 'groupId': 'OG002', 'lowerLimit': '6.09', 'upperLimit': '8.64'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until time of event (maximum up to 10 years)', 'description': 'Secondary cardiac endpoint events included NYHA Class I or II CHF with a drop in LVEF measured by multiple-gated acquisition or electrocardiogram, unless the subsequent assessment of LVEF indicated a return to levels that did not meet the definition of a significant LVEF drop. A significant LVEF drop was defined as an absolute reduction of at least 10 percentage points from Baseline and to a value \\<50%. The percentage of participants with at least one secondary cardiac endpoint event was reported, excluding those with both a primary and secondary cardiac endpoint event. The 95% CI was calculated by the Pearson-Clopper method for a one-sample binomial.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'FG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'FG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Included all participants with available signed Informed Consent Form.', 'groupId': 'FG000', 'numSubjects': '1697'}, {'comment': 'Included all participants with available signed Informed Consent Form.', 'groupId': 'FG001', 'numSubjects': '1702'}, {'comment': 'Included all participants with available signed Informed Consent Form.', 'groupId': 'FG002', 'numSubjects': '1700'}]}, {'type': 'Crossover to Adjuvant Herceptin', 'achievements': [{'groupId': 'FG000', 'numSubjects': '888'}, {'comment': 'This milestone is not applicable to participants who were already randomized to Herceptin.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'This milestone is not applicable to participants who were already randomized to Herceptin.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '834'}, {'groupId': 'FG001', 'numSubjects': '994'}, {'groupId': 'FG002', 'numSubjects': '974'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '863'}, {'groupId': 'FG001', 'numSubjects': '708'}, {'groupId': 'FG002', 'numSubjects': '726'}]}], 'dropWithdraws': [{'type': 'Adverse Event/Intercurrent Illness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'Insufficient Therapeutic Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '542'}, {'groupId': 'FG001', 'numSubjects': '437'}, {'groupId': 'FG002', 'numSubjects': '445'}]}, {'type': 'Violation of Selection Criteria at Entry', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Other Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Refused/Did Not Cooperate/Withdrew', 'reasons': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '93'}, {'groupId': 'FG002', 'numSubjects': '84'}]}, {'type': 'Failure to Return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '62'}, {'groupId': 'FG002', 'numSubjects': '61'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '84'}, {'groupId': 'FG002', 'numSubjects': '105'}]}]}], 'preAssignmentDetails': 'After the release of initial study results, participants in the Observation Arm without disease recurrence were given the opportunity to cross over to receive 1 or 2 years of adjuvant Herceptin. Efficacy analyses were still performed according to original randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1697', 'groupId': 'BG000'}, {'value': '1702', 'groupId': 'BG001'}, {'value': '1700', 'groupId': 'BG002'}, {'value': '5099', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Observation Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.'}, {'id': 'BG001', 'title': 'Herceptin 1-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'BG002', 'title': 'Herceptin 2-Year Arm', 'description': 'Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.2', 'spread': '10.08', 'groupId': 'BG000'}, {'value': '49.0', 'spread': '10.06', 'groupId': 'BG001'}, {'value': '49.2', 'spread': '10.09', 'groupId': 'BG002'}, {'value': '49.1', 'spread': '10.08', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1697', 'groupId': 'BG000'}, {'value': '1702', 'groupId': 'BG001'}, {'value': '1700', 'groupId': 'BG002'}, {'value': '5099', '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': 'Full Analysis Set (FAS) Population: All enrolled/randomized participants who had an available signed Informed Consent Form.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5099}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-17', 'studyFirstSubmitDate': '2002-09-06', 'resultsFirstSubmitDate': '2016-10-19', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-17', 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Disease-Free Survival (DFS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up', 'timeFrame': 'From Baseline until time of event (median of 1 year)', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an Independent Data Monitoring Committee (IDMC) in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.'}, {'measure': 'Percentage of Participants With DFS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up', 'timeFrame': 'From Baseline until time of event (median of 1 year)', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.'}, {'measure': 'DFS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up', 'timeFrame': 'Year 2', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95 percent (%) confidence interval (CI) were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.'}, {'measure': 'DFS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up', 'timeFrame': 'Year 2', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.'}, {'measure': 'Percentage of Participants With DFS Events Compared to Observation: 8-Year Median Follow-Up', 'timeFrame': 'From Baseline until time of event (median of 8 years)', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.'}, {'measure': 'DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up', 'timeFrame': 'Year 3', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.'}, {'measure': 'DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up', 'timeFrame': 'Year 5', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.'}, {'measure': 'DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up', 'timeFrame': 'Year 7', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.'}, {'measure': 'DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up', 'timeFrame': 'Year 8', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.'}, {'measure': 'Percentage of Participants With DFS Events Compared to Observation: 10-Year Maximum Follow-Up', 'timeFrame': 'From Baseline until time of event (maximum of 10 years)', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.'}, {'measure': 'DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up', 'timeFrame': 'Year 3', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.'}, {'measure': 'DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up', 'timeFrame': 'Year 5', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.'}, {'measure': 'DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up', 'timeFrame': 'Year 7', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.'}, {'measure': 'DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up', 'timeFrame': 'Year 8', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.'}, {'measure': 'DFS Rate at Year 9 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up', 'timeFrame': 'Year 9', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.'}, {'measure': 'DFS Rate at Year 10 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up', 'timeFrame': 'Year 10', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With DFS Events in 1-Year Versus 2-Year Herceptin: 10-Year Maximum Follow-Up', 'timeFrame': 'From Baseline until time of event (maximum of 10 years)', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.'}, {'measure': 'DFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 10-Year Maximum Follow-Up', 'timeFrame': 'Years 3, 5, 7, 8, 9, 10', 'description': 'DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.'}, {'measure': 'Percentage of Participants With Overall Survival (OS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up', 'timeFrame': 'From Baseline until time of event (median of 1 year)', 'description': 'OS events referred to death from any cause. The percentage of participants who died was reported. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.'}, {'measure': 'Percentage of Participants With OS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up', 'timeFrame': 'From Baseline until time of event (median of 1 year)', 'description': 'OS events referred to death from any cause. The percentage of participants who died was reported. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.'}, {'measure': 'OS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up', 'timeFrame': 'Year 2', 'description': 'OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.'}, {'measure': 'OS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up', 'timeFrame': 'Year 2', 'description': 'OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.'}, {'measure': 'Percentage of Participants With OS Events Compared to Observation: 8-Year Median Follow-Up', 'timeFrame': 'From Baseline until time of event (median of 8 years)', 'description': 'OS events referred to death from any cause. The percentage of participants who died was reported.'}, {'measure': 'OS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up', 'timeFrame': 'Years 3, 5, 7, 8', 'description': 'OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.'}, {'measure': 'Percentage of Participants With OS Events Compared to Observation: 11-Year Median Follow-Up', 'timeFrame': 'From Baseline until time of event (median of 11 years)', 'description': 'OS events referred to death from any cause. The percentage of participants who died was reported.'}, {'measure': 'OS Rate According to Kaplan-Meier Analysis Compared to Observation: 11-Year Median Follow-Up', 'timeFrame': 'Years 3, 5, 7, 9, 10, 11, 12', 'description': 'OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with an 11-year median follow-up for OS events.'}, {'measure': 'Percentage of Participants With OS Events in 1-Year Versus 2-Year Herceptin: 11-Year Median Follow-Up', 'timeFrame': 'From Baseline until time of event (median of 11 years)', 'description': 'OS events referred to death from any cause. The percentage of participants who died was reported.'}, {'measure': 'OS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 11-Year Median Follow-Up', 'timeFrame': 'Years 3, 5, 7, 9, 10, 11, 12', 'description': 'OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with an 11-year median follow-up for OS events.'}, {'measure': 'Percentage of Participants With Recurrence-Free Survival (RFS) Events Compared to Observation: 8-Year Median Follow-Up', 'timeFrame': 'From Baseline until time of event (median of 8 years)', 'description': 'RFS events included local, regional, or distant tumor recurrence. The percentage of participants with at least one RFS event was reported.'}, {'measure': 'RFS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up', 'timeFrame': 'Years 3, 5, 7, 8', 'description': 'RFS events included local, regional, or distant tumor recurrence. The percentage of participants free of RFS events (i.e., the RFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.'}, {'measure': 'Percentage of Participants With RFS Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up', 'timeFrame': 'From Baseline until time of event (median of 8 years)', 'description': 'RFS events included local, regional, or distant tumor recurrence. The percentage of participants with at least one RFS event was reported.'}, {'measure': 'RFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up', 'timeFrame': 'Years 3, 5, 7, 8', 'description': 'RFS events included local, regional, or distant tumor recurrence. The percentage of participants free of RFS events (i.e., the RFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.'}, {'measure': 'Percentage of Participants With Distant Disease-Free Survival (DDFS) Events Compared to Observation: 8-Year Median Follow-Up', 'timeFrame': 'From Baseline until time of event (median of 8 years)', 'description': 'DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants with at least one DDFS event was reported.'}, {'measure': 'DDFS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up', 'timeFrame': 'Years 3, 5, 7, 8', 'description': 'DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants free of DDFS events (i.e., the DDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.'}, {'measure': 'Percentage of Participants With DDFS Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up', 'timeFrame': 'From Baseline until time of event (median of 8 years)', 'description': 'DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants with at least one DDFS event was reported.'}, {'measure': 'DDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up', 'timeFrame': 'Years 3, 5, 7, 8', 'description': 'DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants free of DDFS events (i.e., the DDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.'}, {'measure': 'Percentage of Participants With Tumor Recurrence (TR) Compared to Observation: 8-Year Median Follow-Up', 'timeFrame': 'From Baseline until time of event (median of 8 years)', 'description': 'The percentage of participants with TR of the present breast cancer was reported. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.'}, {'measure': 'TR-Free Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up', 'timeFrame': 'Years 3, 5, 7, 8', 'description': 'The percentage of participants without TR of the present breast cancer (i.e., the TR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.'}, {'measure': 'Percentage of Participants With TR in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up', 'timeFrame': 'From Baseline until time of event (median of 8 years)', 'description': 'The percentage of participants with TR of the present breast cancer was reported. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.'}, {'measure': 'TR-Free Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up', 'timeFrame': 'Years 3, 5, 7, 8', 'description': 'The percentage of participants without TR of the present breast cancer (i.e., the TR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.'}, {'measure': 'Percentage of Participants With Distant Tumor Recurrence (DTR) Compared to Observation: 8-Year Median Follow-Up', 'timeFrame': 'From Baseline until time of event (median of 8 years)', 'description': 'The percentage of participants with DTR was reported. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.'}, {'measure': 'DTR-Free Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up', 'timeFrame': 'Years 3, 5, 7, 8', 'description': 'The percentage of participants without DTR (i.e., the DTR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.'}, {'measure': 'Percentage of Participants With DTR in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up', 'timeFrame': 'From Baseline until time of event (median of 8 years)', 'description': 'The percentage of participants with DTR was reported. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.'}, {'measure': 'DTR-Free Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up', 'timeFrame': 'Years 3, 5, 7, 8', 'description': 'The percentage of participants without DTR (i.e., the DTR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.'}, {'measure': 'Percentage of Participants With Restricted Disease-Free Survival (RDFS) Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up', 'timeFrame': 'From Baseline until time of event (median of 8 years)', 'description': 'RDFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer, or death from any cause. The percentage of participants with at least one RDFS event was reported.'}, {'measure': 'RDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up', 'timeFrame': 'Years 3, 5, 7, 8', 'description': 'RDFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer, or death from any cause. The percentage of participants free of RDFS events (i.e., the RDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.'}, {'measure': 'Percentage of Participants With Primary Cardiac Endpoint Events Compared to Observation: 10-Year Maximum Follow-Up', 'timeFrame': 'From Baseline until time of event (maximum up to 10 years)', 'description': 'Primary cardiac endpoint events included the occurrence of any of the following between randomization and new therapy for recurrent disease: symptomatic New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF) confirmed by a cardiologist with a drop in left ventricular ejection fraction (LVEF) at least 10 percentage points from Baseline and to a value less than (\\<) 50%, and documentation of definite or probable cardiac death. Definite cardiac death included CHF, myocardial infarction, or primary arrhythmia. Probable cardiac death included unexpected sudden death within 24 hours of a cardiac event (syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology. The percentage of participants with at least one primary cardiac endpoint event was reported. The 95% CI was calculated by the Pearson-Clopper method for a one-sample binomial.'}, {'measure': 'Percentage of Participants With Secondary Cardiac Endpoint Events Compared to Observation: 10-Year Maximum Follow-Up', 'timeFrame': 'From Baseline until time of event (maximum up to 10 years)', 'description': 'Secondary cardiac endpoint events included NYHA Class I or II CHF with a drop in LVEF measured by multiple-gated acquisition or electrocardiogram, unless the subsequent assessment of LVEF indicated a return to levels that did not meet the definition of a significant LVEF drop. A significant LVEF drop was defined as an absolute reduction of at least 10 percentage points from Baseline and to a value \\<50%. The percentage of participants with at least one secondary cardiac endpoint event was reported, excluding those with both a primary and secondary cardiac endpoint event. The 95% CI was calculated by the Pearson-Clopper method for a one-sample binomial.'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '18757259', 'type': 'BACKGROUND', 'citation': 'Jahanzeb M. Adjuvant trastuzumab therapy for HER2-positive breast cancer. Clin Breast Cancer. 2008 Aug;8(4):324-33. doi: 10.3816/CBC.2008.n.037.'}, {'pmid': '17661170', 'type': 'BACKGROUND', 'citation': 'Shiroiwa T, Fukuda T, Shimozuma K, Ohashi Y, Tsutani K. The model-based cost-effectiveness analysis of 1-year adjuvant trastuzumab treatment: based on 2-year follow-up HERA trial data. Breast Cancer Res Treat. 2008 Jun;109(3):559-66. doi: 10.1007/s10549-007-9679-4. 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J Clin Oncol. 2007 Sep 1;25(25):3859-65. doi: 10.1200/JCO.2006.09.1611. Epub 2007 Jul 23.'}, {'pmid': '16236737', 'type': 'RESULT', 'citation': 'Piccart-Gebhart MJ, Procter M, Leyland-Jones B, Goldhirsch A, Untch M, Smith I, Gianni L, Baselga J, Bell R, Jackisch C, Cameron D, Dowsett M, Barrios CH, Steger G, Huang CS, Andersson M, Inbar M, Lichinitser M, Lang I, Nitz U, Iwata H, Thomssen C, Lohrisch C, Suter TM, Ruschoff J, Suto T, Greatorex V, Ward C, Straehle C, McFadden E, Dolci MS, Gelber RD; Herceptin Adjuvant (HERA) Trial Study Team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005 Oct 20;353(16):1659-72. doi: 10.1056/NEJMoa052306.'}, {'pmid': '40175431', 'type': 'DERIVED', 'citation': 'Bae SJ, Moon S, Kook Y, Baek SH, Lee M, Kim JH, Ahn SG, Jeong J. Clinical relevance of clinical treatment score post-5 years (CTS5) in HR-positive, HER2-positive breast cancer. 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Efficacy of Adjuvant Trastuzumab for Patients With Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer and Tumors </= 2 cm: A Meta-Analysis of the Randomized Trastuzumab Trials. J Clin Oncol. 2015 Aug 20;33(24):2600-8. doi: 10.1200/JCO.2015.60.8620. Epub 2015 Jun 22."}, {'pmid': '24912899', 'type': 'DERIVED', 'citation': 'de Azambuja E, Procter MJ, van Veldhuisen DJ, Agbor-Tarh D, Metzger-Filho O, Steinseifer J, Untch M, Smith IE, Gianni L, Baselga J, Jackisch C, Cameron DA, Bell R, Leyland-Jones B, Dowsett M, Gelber RD, Piccart-Gebhart MJ, Suter TM. Trastuzumab-associated cardiac events at 8 years of median follow-up in the Herceptin Adjuvant trial (BIG 1-01). J Clin Oncol. 2014 Jul 10;32(20):2159-65. doi: 10.1200/JCO.2013.53.9288. Epub 2014 Jun 9.'}, {'pmid': '23894039', 'type': 'DERIVED', 'citation': 'Zabaglo L, Stoss O, Ruschoff J, Zielinski D, Salter J, Arfi M, Bradbury I, Dafni U, Piccart-Gebhart M, Procter M, Dowsett M; HERA Trial Study Team. HER2 staining intensity in HER2-positive disease: relationship with FISH amplification and clinical outcome in the HERA trial of adjuvant trastuzumab. Ann Oncol. 2013 Nov;24(11):2761-6. doi: 10.1093/annonc/mdt275. Epub 2013 Jul 25.'}, {'pmid': '23871490', 'type': 'DERIVED', 'citation': 'Goldhirsch A, Gelber RD, Piccart-Gebhart MJ, de Azambuja E, Procter M, Suter TM, Jackisch C, Cameron D, Weber HA, Heinzmann D, Dal Lago L, McFadden E, Dowsett M, Untch M, Gianni L, Bell R, Kohne CH, Vindevoghel A, Andersson M, Brunt AM, Otero-Reyes D, Song S, Smith I, Leyland-Jones B, Baselga J; Herceptin Adjuvant (HERA) Trial Study Team. 2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial. Lancet. 2013 Sep 21;382(9897):1021-8. doi: 10.1016/S0140-6736(13)61094-6. Epub 2013 Jul 18.'}, {'pmid': '23589556', 'type': 'DERIVED', 'citation': 'Metzger-Filho O, Procter M, de Azambuja E, Leyland-Jones B, Gelber RD, Dowsett M, Loi S, Saini KS, Cameron D, Untch M, Smith I, Gianni L, Baselga J, Jackisch C, Bell R, Sotiriou C, Viale G, Piccart-Gebhart M. Magnitude of trastuzumab benefit in patients with HER2-positive, invasive lobular breast carcinoma: results from the HERA trial. J Clin Oncol. 2013 Jun 1;31(16):1954-60. doi: 10.1200/JCO.2012.46.2440. Epub 2013 Apr 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years (versus observation/no Herceptin) in women with HER2-overexpressing primary breast cancer who have completed (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable. Efficacy and safety will be assessed for 10 years from randomization for each participant. All participants will continue to be followed for survival until 10 years after enrollment of the last participant.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-metastatic primary invasive breast cancer overexpressing HER2 (determined by immunohistochemistry 3+ or positive fluorescence in situ hybridization test) that has been histologically confirmed, adequately excised, axillary node positive or negative, and tumor size at least T1c according to Tumor/Node/Metastasis (TNM) staging\n* Completion of at least 4 cycles of (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable\n* Known hormone receptor status\n* Baseline left ventricular ejection fraction (LVEF) greater than or equal to (≥) 55 percent (%)\n\nExclusion Criteria:\n\n* Prior invasive breast carcinoma\n* Other malignancies except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix\n* Clinical T4 tumors\n* Cumulative doxorubicin exposure greater than (\\>) 360 milligrams per meter-squared (mg/m\\^2) or epirubicin \\>720 mg/m\\^2 or any prior anthracyclines unrelated to the present breast cancer\n* Peripheral stem cell or bone marrow stem cell support\n* Prior mediastinal irradiation except for internal mammary node irradiation for the present breast cancer\n* Non-irradiated internal mammary nodes or supraclavicular lymph node involvement\n* Prior anti-HER2 therapy for any other reason or other prior biologic or immunotherapy for breast cancer\n* Concurrent anti-cancer treatment in another investigational trial\n* Serious cardiac or pulmonary conditions/illness, or any other conditions that could interfere with planned treatment\n* Poor hematologic, hepatic, or renal function\n* Pregnancy or lactation\n* Women of childbearing potential or less than 1 year post-menopause unwilling to use adequate contraceptive measures'}, 'identificationModule': {'nctId': 'NCT00045032', 'acronym': 'HERA', 'briefTitle': 'Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized Three-Arm, Multicenter Comparison of 1 Year and 2 Years of Herceptin Versus No Herceptin in Women With HER2-Positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy', 'orgStudyIdInfo': {'id': 'BO16348'}, 'secondaryIdInfos': [{'id': 'BIG-01-01'}, {'id': 'EU-20216'}, {'id': 'ROCHE-B016348E'}, {'id': 'ROCHE-B016348C'}, {'id': 'EORTC-10011'}, {'id': 'CAN-NCIC-MA24'}, {'id': 'IBCSG-28-02'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Observation Arm', 'description': 'Participants who have completed definitive surgery and systemic adjuvant chemotherapy will be observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin will be provided.'}, {'type': 'EXPERIMENTAL', 'label': 'Herceptin 1-Year Arm', 'description': 'Participants who have completed definitive surgery and systemic adjuvant chemotherapy will receive Herceptin for 1 year or until disease recurrence, whichever occurs first. Participants will be observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.', 'interventionNames': ['Drug: Herceptin']}, {'type': 'EXPERIMENTAL', 'label': 'Herceptin 2-Year Arm', 'description': 'Participants who have completed definitive surgery and systemic adjuvant chemotherapy will receive Herceptin for 2 years or until disease recurrence, whichever occurs first. Participants will be observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.', 'interventionNames': ['Drug: Herceptin']}], 'interventions': [{'name': 'Herceptin', 'type': 'DRUG', 'otherNames': ['Trastuzumab'], 'description': 'Herceptin will be given as a loading dose of 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks.', 'armGroupLabels': ['Herceptin 1-Year Arm']}, {'name': 'Herceptin', 'type': 'DRUG', 'otherNames': ['Trastuzumab'], 'description': 'Herceptin will be given as a loading dose of 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks.', 'armGroupLabels': ['Herceptin 2-Year Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1118', 'city': 'Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Aleman de Buenos Aires'}, {'zip': '3220', 'city': 'Geelong', 'state': 'Australian Capital Territory', 'country': 'Australia', 'facility': 'Saint John of God Hospital'}, {'zip': '4350', 'city': 'Toowoomba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Toowoomba Hospital', 'geoPoint': {'lat': -27.56056, 'lon': 151.95386}}, {'zip': '3220', 'city': 'Geelong', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Andrew Love Cancer Centre', 'geoPoint': {'lat': -38.14711, 'lon': 144.36069}}, {'zip': '6000', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Mount Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '6807', 'city': 'Feldkirch-Tisis', 'country': 'Austria', 'facility': 'Landeskrankenhaus Feldkirch'}, {'zip': 'A-6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Innsbruck Universitaetsklinik', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '9026', 'city': 'Klagenfurt', 'country': 'Austria', 'facility': 'Landeskrankenhaus Klagenfurt', 'geoPoint': {'lat': 46.62472, 'lon': 14.30528}}, {'zip': 'A-4010', 'city': 'Linz Donau', 'country': 'Austria', 'facility': "St. Vincent's Hospital"}, {'zip': 'A-5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Landeskrankenanstalten - Salzburg', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '3100', 'city': 'Sankt Pölten', 'country': 'Austria', 'facility': 'Landeskrankenhaus St. Poelten', 'geoPoint': {'lat': 48.20762, 'lon': 15.63725}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Universitaetsklinik fuer Innere Medizin I', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'A-1160', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Wilhelminenspital der Stadt Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '9500', 'city': 'Villach', 'country': 'Austria', 'facility': 'LKH Villach', 'geoPoint': {'lat': 46.61028, 'lon': 13.85583}}, {'zip': '4840', 'city': 'Vöcklabruck', 'country': 'Austria', 'facility': 'LKH Voecklabruck', 'geoPoint': {'lat': 48.00279, 'lon': 13.65652}}, {'zip': 'A-2700', 'city': 'Wiener Neustadt', 'country': 'Austria', 'facility': 'A. oe. 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Marie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Algoma Regional Cancer Program at Sault Area Hospital', 'geoPoint': {'lat': 46.51677, 'lon': -84.33325}}, {'zip': 'L2R 5K3', 'city': 'St. Catharines', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hotel Dieu Health Sciences Hospital - Niagara', 'geoPoint': {'lat': 43.17126, 'lon': -79.24267}}, {'zip': 'M4C 3E7', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto East General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital - Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N8W 2X3', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Windsor Regional Cancer Centre at Windsor Regional Hospital', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'C1A 8T5', 'city': 'Charlottetown', 'state': 'Prince Edward Island', 'country': 'Canada', 'facility': 'Prince Edward Island Cancer Centre at Queen Elizabeth Hospital', 'geoPoint': {'lat': 46.23459, 'lon': -63.1256}}, {'zip': 'G1S 4L8', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital du Saint-Sacrement, Quebec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'S4T 7T1', 'city': 'Regina', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Allan Blair Cancer Centre at Pasqua Hospital', 'geoPoint': {'lat': 50.45008, 'lon': -104.6178}}, {'zip': 'S7N 4H4', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Saskatoon Cancer Centre at the University of Saskatchewan', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}, {'zip': '29', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Fundacion Arturo Lopez Perez', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Hospital Clinico San Borja Arriaran', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Hospital Dr. Sotero Del Rio', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Hospital Militar', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Instituto Nacional Del Cancer', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Hong Kong', 'country': 'China', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'China', 'facility': 'Tuen Mun Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '430030', 'city': 'Wuhan', 'country': 'China', 'facility': 'Tongji Medical University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Instituto Nacional De Cancerologia', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'zip': '21000', 'city': 'Split', 'country': 'Croatia', 'facility': 'Clinical Hospital Center Split', 'geoPoint': {'lat': 43.50891, 'lon': 16.43915}}, {'zip': '6700', 'city': 'Esbjerg', 'country': 'Denmark', 'facility': 'Centralsygehus I Esbjerg', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}, {'zip': '7400', 'city': 'Herning', 'country': 'Denmark', 'facility': 'Herning Central Hospital', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}, {'zip': '3400', 'city': 'Hillerød', 'country': 'Denmark', 'facility': 'Hillerod Hospital', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}, {'zip': '4700', 'city': 'Næstved', 'country': 'Denmark', 'facility': 'Centralsygehuset I Naestved', 'geoPoint': {'lat': 55.22992, 'lon': 11.76092}}, {'zip': '6400', 'city': 'Sønderborg', 'country': 'Denmark', 'facility': 'Sonderborg Sygehus', 'geoPoint': {'lat': 54.90896, 'lon': 9.78917}}, {'zip': '14076', 'city': 'Caen', 'country': 'France', 'facility': 'Centre Regional Francois Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Centre Hospital Regional Universitaire de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '57072', 'city': 'Metz', 'country': 'France', 'facility': 'Hopital Clinique Claude Bernard', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'zip': 'D-10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite - Campus Charite Mitte', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'D-45355', 'city': 'Essen', 'country': 'Germany', 'facility': 'Evangelisches Bethesda Krankenhaus GmbH', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': 'D-79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Universitaetsklinikum Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': 'D-06097', 'city': 'Halle', 'country': 'Germany', 'facility': 'Martin Luther Universitaet', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': 'D-30559', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Henriettenstiftung Krankenhaus', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': 'D-69115', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universitaets-Hautklinik Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': 'D-76137', 'city': 'Karlsruhe', 'country': 'Germany', 'facility': 'St. Vincentius-Kliniken', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': 'D-24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'University Hospital Schleswig-Holstein - 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