Viewing Study NCT03262935

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Ignite Creation Date: 2025-12-24 @ 10:13 PM
Ignite Modification Date: 2025-12-31 @ 3:27 AM
Study NCT ID: NCT03262935
Status: COMPLETED
Last Update Posted: 2023-10-19
First Post: 2017-08-16
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}}}}, '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': 'C000656468', 'term': 'trastuzumab duocarmazine'}, {'id': 'D000077341', 'term': 'Lapatinib'}, {'id': 'D022782', 'term': 'CCAAT-Enhancer-Binding Protein-beta'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D002214', 'term': 'Capsules'}, {'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'C490954', 'term': 'eribulin'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D022762', 'term': 'CCAAT-Enhancer-Binding Proteins'}, {'id': 'D050976', 'term': 'Basic-Leucine Zipper Transcription Factors'}, {'id': 'D004268', 'term': 'DNA-Binding Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009687', 'term': 'Nuclear Proteins'}, {'id': 'D014157', 'term': 'Transcription Factors'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'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': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@byondis.com', 'phone': '0031246795101', 'title': 'Clinical Development', 'organization': 'Byondis B.V.'}, 'certainAgreement': {'otherDetails': 'The PI agrees to provide to the Sponsor 60 days prior to intended submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study. The Sponsor has the right to review and comment with respect to publications, abstracts, slides, and manuscripts including the data analysis and presentation. In case of disagreement, efforts will be undertaken to resolve any such issues, but the ultimate decision remains with the Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected from signing of the ICF up to the treatment discontinuation visit. The safety data reported here is based on data collected up to the data cut off date of 31 March 2021.', 'eventGroups': [{'id': 'EG000', 'title': '(Vic-)Trastuzumab Duocarmazine', 'description': 'SYD985, every 3 weeks (Q3W)\n\n(vic-)trastuzumab duocarmazine: Intravenous SYD985, Q3W', 'otherNumAtRisk': 288, 'deathsNumAtRisk': 288, 'otherNumAffected': 278, 'seriousNumAtRisk': 288, 'deathsNumAffected': 181, 'seriousNumAffected': 53}, {'id': 'EG001', 'title': "Physician's Choice", 'description': "1. Lap/Cap\n2. T/Cap\n3. T/Vino\n4. T/Eri\n\nPhysician's choice: See drug label", 'otherNumAtRisk': 137, 'deathsNumAtRisk': 137, 'otherNumAffected': 132, 'seriousNumAtRisk': 137, 'deathsNumAffected': 94, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 45, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 26, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 28, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 25, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 26, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 19, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 17, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 37, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 23, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 26, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 29, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 16, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 162, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 66, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 91, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 34, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 26, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 30, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 85, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 35, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 75, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 76, 'numAffected': 33}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 23, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 13, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 218, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 202, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 117, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 74, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 53, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 45, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 30, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Periorbital oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 29, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 103, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 64, 'numAffected': 43}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 82, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 92, 'numAffected': 49}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 74, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 28, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 52, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 37, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 28, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 34, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 30, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 17, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 60, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 52, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 27, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 23, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 74, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 21, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 36, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 70, 'numAffected': 32}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 36, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 23, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 19, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 28, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 75, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 20, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'seriousEvents': [{'term': 'Chronic myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Haemorrhagic tumour necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Infected neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and 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23.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Uterine haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 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[{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumothorax', 'stats': 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'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Staphylococcus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Eyelid ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Livedo reticularis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Infectious pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Neutropenic sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '(Vic-)Trastuzumab Duocarmazine', 'description': 'SYD985, every 3 weeks (Q3W)\n\n(vic-)trastuzumab duocarmazine: Intravenous SYD985, Q3W'}, {'id': 'OG001', 'title': "Physician's Choice", 'description': "1. Lap/Cap\n2. T/Cap\n3. T/Vino\n4. T/Eri\n\nPhysician's choice: See drug label"}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '7.2'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '5.5'}]}]}], 'analyses': [{'pValue': '=0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6401', 'ciLowerLimit': '0.4885', 'ciUpperLimit': '0.8389', 'pValueComment': 'P-value from stratified log-rank test for median estimate of PFS: stratified according to the randomization stratification factors.', 'groupDescription': 'A stratified Cox regression analysis was used to estimate the hazard ratio of PFS, along with 95% CIs. Stratification factors assigned at randomization were world region (Europe, Singapore, and North America), number of prior treatment lines for locally advanced or metastatic breast cancer (excluding hormone therapy) (1 to 2, \\>2), and prior treatment with pertuzumab (yes, no).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline until primary analysis data cut-off date of 31March2021', 'description': 'Progression-free survival is defined as the time from the date of randomization to the date of first documented disease progression by central assessment according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurred earlier.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full-analysis set (FAS) was used for this primary endpoint analysis. FAS comprises all randomized patients, which were analyzed according to the treatment group and strata they have been assigned to during the randomization procedure.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '(Vic-)Trastuzumab Duocarmazine', 'description': 'SYD985, every 3 weeks (Q3W)\n\n(vic-)trastuzumab duocarmazine: Intravenous SYD985, Q3W'}, {'id': 'OG001', 'title': "Physician's Choice", 'description': "1. Lap/Cap\n2. T/Cap\n3. T/Vino\n4. T/Eri\n\nPhysician's choice: See drug label"}], 'classes': [{'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000', 'lowerLimit': '18.1', 'upperLimit': '25.0'}, {'value': '19.5', 'groupId': 'OG001', 'lowerLimit': '14.2', 'upperLimit': '23.1'}]}]}], 'analyses': [{'pValue': '=0.236', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.868', 'ciLowerLimit': '0.676', 'ciUpperLimit': '1.1145', 'pValueComment': 'P-value from stratified log-rank test for Kaplan-Meier estimate of median OS: stratified according to the randomization stratification factors.', 'groupDescription': 'A stratified Cox regression analysis was used to estimate the hazard ratio of OS, along with 95% CIs. Stratification factors assigned at randomization were world region (Europe, Singapore, and North America), number of prior treatment lines for locally advanced or metastatic breast cancer (excluding hormone therapy) (1 to 2, \\>2), and prior treatment with pertuzumab (yes, no).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline until final Overall Survival analysis data cut-off date of 30June2022', 'description': 'Overall survival is defined as the time from date of randomization to death due to any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full-analysis set (FAS) was used for the overall survival analysis. FAS comprises all randomized patients, which were analyzed according to the treatment group and strata they have been assigned to during the randomization procedure.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '(Vic-)Trastuzumab Duocarmazine', 'description': 'SYD985, every 3 weeks (Q3W)\n\n(vic-)trastuzumab duocarmazine: Intravenous SYD985, Q3W'}, {'id': 'OG001', 'title': "Physician's Choice", 'description': "1. Lap/Cap\n2. T/Cap\n3. T/Vino\n4. T/Eri\n\nPhysician's choice: See drug label"}], 'classes': [{'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000', 'lowerLimit': '22.3', 'upperLimit': '33.7'}, {'value': '29.5', 'groupId': 'OG001', 'lowerLimit': '21.6', 'upperLimit': '38.4'}]}]}], 'analyses': [{'pValue': '=0.732', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value from Cochran-Mantel-Haenszel test including the randomization stratification factors.', 'groupDescription': 'The Cochran-Mantel-Haenszel test (strata based on the baseline stratification factors) was used to compare the two treatment groups with respect to the ORR at two-sided 5% level of significance.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'baseline until primary analysis data cut-off date of 31March2021', 'description': 'Objective Response Rate is defined as the proportion of patients with a centrally assessed best overall response of complete response or partial response according to RECIST v1.1.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full-analysis set (FAS) was used for this primary endpoint analysis. FAS comprises all randomized patients, which were analyzed according to the treatment group and strata they have been assigned to during the randomization procedure. Only patients with measurable disease at baseline were included in the analysis of ORR.'}, {'type': 'SECONDARY', 'title': 'Investigator Assessed Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '(Vic-)Trastuzumab Duocarmazine', 'description': 'SYD985, every 3 weeks (Q3W)\n\n(vic-)trastuzumab duocarmazine: Intravenous SYD985, Q3W'}, {'id': 'OG001', 'title': "Physician's Choice", 'description': "1. Lap/Cap\n2. T/Cap\n3. T/Vino\n4. T/Eri\n\nPhysician's choice: See drug label"}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '7.2'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '5.6'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5995', 'ciLowerLimit': '0.4666', 'ciUpperLimit': '0.7703', 'pValueComment': 'P-value from stratified log-rank test for median estimate of PFS: stratified according to the randomization stratification factors.', 'groupDescription': 'A stratified Cox regression analysis was used to estimate the HR of PFS, along with the 95% CI. The treatment groups were compared using the 2-sided stratified log-rank test.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline until primary analysis data cut-off date of 31March2021', 'description': 'Progression-free survival is defined as the time from the date of randomization to the date of first documented disease progression by investigator assessment according to RECIST v1.1 or death due to any cause, whichever occurred earlier.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full-analysis set (FAS) was used for this primary endpoint analysis. FAS comprises all randomized patients, which were analyzed according to the treatment group and strata they have been assigned to during the randomization procedure.'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcomes for Health Related Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '(Vic-)Trastuzumab Duocarmazine', 'description': 'SYD985, every 3 weeks (Q3W)\n\n(vic-)trastuzumab duocarmazine: Intravenous SYD985, Q3W'}, {'id': 'OG001', 'title': "Physician's Choice", 'description': "1. Lap/Cap\n2. T/Cap\n3. T/Vino\n4. T/Eri\n\nPhysician's choice: See drug label"}], 'classes': [{'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG000', 'lowerLimit': '-2.70', 'upperLimit': '3.04'}, {'value': '-3.88', 'groupId': 'OG001', 'lowerLimit': '-7.79', 'upperLimit': '0.03'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.88', 'groupId': 'OG000', 'lowerLimit': '-4.83', 'upperLimit': '1.07'}, {'value': '-2.99', 'groupId': 'OG001', 'lowerLimit': '-7.00', 'upperLimit': '1.02'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.48', 'groupId': 'OG000', 'lowerLimit': '-5.46', 'upperLimit': '0.50'}, {'value': '-9.01', 'groupId': 'OG001', 'lowerLimit': '-13.23', 'upperLimit': '-4.80'}]}]}, {'title': 'Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.51', 'groupId': 'OG000', 'lowerLimit': '-5.69', 'upperLimit': '0.67'}, {'value': '-5.77', 'groupId': 'OG001', 'lowerLimit': '-10.34', 'upperLimit': '-1.21'}]}]}, {'title': 'Cycle 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.65', 'groupId': 'OG000', 'lowerLimit': '-9.19', 'upperLimit': '-2.10'}, {'value': '-6.75', 'groupId': 'OG001', 'lowerLimit': '-11.92', 'upperLimit': '-1.58'}]}]}, {'title': 'Cycle 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.14', 'groupId': 'OG000', 'lowerLimit': '-12.27', 'upperLimit': '-4.02'}, {'value': '-11.25', 'groupId': 'OG001', 'lowerLimit': '-17.41', 'upperLimit': '-5.09'}]}]}, {'title': 'Cycle 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.70', 'groupId': 'OG000', 'lowerLimit': '-15.66', 'upperLimit': '-5.75'}, {'value': '-10.38', 'groupId': 'OG001', 'lowerLimit': '-18.08', 'upperLimit': '-2.69'}]}]}, {'title': 'Cycle 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-13.40', 'groupId': 'OG000', 'lowerLimit': '-20.31', 'upperLimit': '-6.48'}, {'value': '-12.89', 'groupId': 'OG001', 'lowerLimit': '-21.33', 'upperLimit': '-4.45'}]}]}, {'title': 'Cycle 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.90', 'groupId': 'OG000', 'lowerLimit': '-20.41', 'upperLimit': '-3.39'}, {'value': '-14.12', 'groupId': 'OG001', 'lowerLimit': '-23.91', 'upperLimit': '-4.33'}]}]}, {'title': 'Cycle 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.31', 'groupId': 'OG000', 'lowerLimit': '-14.48', 'upperLimit': '5.86'}, {'value': '-0.71', 'groupId': 'OG001', 'lowerLimit': '-13.26', 'upperLimit': '11.83'}]}]}, {'title': 'Cycle 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.45', 'groupId': 'OG000', 'lowerLimit': '-21.05', 'upperLimit': '10.16'}, {'value': '1.66', 'groupId': 'OG001', 'lowerLimit': '-13.84', 'upperLimit': '17.16'}]}]}, {'title': 'Cycle 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.68', 'groupId': 'OG000', 'lowerLimit': '-9.76', 'upperLimit': '33.12'}, {'value': '-11.23', 'groupId': 'OG001', 'lowerLimit': '-26.16', 'upperLimit': '3.71'}]}]}, {'title': 'Cycle 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.30', 'groupId': 'OG000', 'lowerLimit': '-26.04', 'upperLimit': '36.65'}, {'value': '-7.00', 'groupId': 'OG001', 'lowerLimit': '-29.18', 'upperLimit': '15.17'}]}]}, {'title': 'Cycle 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.76', 'groupId': 'OG000', 'lowerLimit': '-14.63', 'upperLimit': '52.16'}, {'value': '-11.48', 'groupId': 'OG001', 'lowerLimit': '-42.96', 'upperLimit': '19.99'}]}]}, {'title': 'Cycle 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.49', 'groupId': 'OG000', 'lowerLimit': '-33.40', 'upperLimit': '34.37'}, {'value': '-5.41', 'groupId': 'OG001', 'lowerLimit': '-38.83', 'upperLimit': '28.02'}]}]}, {'title': 'Cycle 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.54', 'groupId': 'OG001', 'lowerLimit': '-40.45', 'upperLimit': '27.37'}]}]}, {'title': 'Cycle 33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.11', 'groupId': 'OG001', 'lowerLimit': '-41.14', 'upperLimit': '26.92'}]}]}, {'title': 'Cycle 35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.73', 'groupId': 'OG001', 'lowerLimit': '-49.79', 'upperLimit': '18.33'}]}]}], 'analyses': [{'pValue': '0.473', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The change from baseline in the global health status/QoL scale transformed score was analyzed using a mixed model repeated measurement (MMRM) approach.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline until primary analysis data cut-off date of 31March2021', 'description': 'Change in the global health status/Quality of Life (QoL) scale score of the European Organization for Research and Treatment for Cancer (EORTC) Quality of Life Questionnaire C30 from baseline (cycle 1). The raw score (1 to 7) has been transformed to a score ranging from 0 to 100. A higher score means a better outcome: hence a positive change from baseline means an improvement in global health status/Quality of Life and a negative change from baseline means a worsening of global health status/Quality of Life.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Full-analysis set (FAS) was used for the overall survival analysis. FAS comprises all randomized patients, which were analyzed according to the treatment group and strata they have been assigned to during the randomization procedure. Here, 'Number analyzed' = participants with available QoL for each specified cycle."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '(Vic-)Trastuzumab Duocarmazine', 'description': 'SYD985, every 3 weeks (Q3W)\n\n(vic-)trastuzumab duocarmazine: Intravenous SYD985, Q3W'}, {'id': 'FG001', 'title': "Physician's Choice", 'description': "1. Lap/Cap\n2. T/Cap\n3. T/Vino\n4. T/Eri\n\nPhysician's choice: See drug label"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '291'}, {'groupId': 'FG001', 'numSubjects': '146'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '291'}, {'groupId': 'FG001', 'numSubjects': '146'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'End Of Follow Up By Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '181'}, {'groupId': 'FG001', 'numSubjects': '94'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 751 participants were screened, out of which, 437 participants were randomized into the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '(Vic-)Trastuzumab Duocarmazine', 'description': 'SYD985, every 3 weeks (Q3W)\n\n(vic-)trastuzumab duocarmazine: Intravenous SYD985, Q3W'}, {'id': 'BG001', 'title': "Physician's Choice", 'description': "1. Lap/Cap\n2. T/Cap\n3. T/Vino\n4. T/Eri\n\nPhysician's choice: See drug label"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '55.9', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '57.3', 'spread': '10.97', 'groupId': 'BG001'}, {'value': '56.4', 'spread': '11.13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '291', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '225', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '328', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '297', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Singapore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25.14', 'spread': '5.0', 'groupId': 'BG000'}, {'value': '25.54', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '25.28', 'spread': '5.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': "The number analyzed differs from the overall because height was missing for 3 patients in the SYD985 group and for 1 patient in the Physician's choice group."}, {'title': 'Childbearing potential', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'No - postmenopausal', 'measurements': [{'value': '204', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}]}, {'title': 'No - surgically sterilized', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-18', 'size': 2484322, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-06-30T16:16', 'hasProtocol': True}, {'date': '2021-04-29', 'size': 1674332, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-06-30T16:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 437}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-28', 'studyFirstSubmitDate': '2017-08-16', 'resultsFirstSubmitDate': '2023-06-30', 'studyFirstSubmitQcDate': '2017-08-23', 'lastUpdatePostDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-28', 'studyFirstPostDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': 'baseline until primary analysis data cut-off date of 31March2021', 'description': 'Progression-free survival is defined as the time from the date of randomization to the date of first documented disease progression by central assessment according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurred earlier.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'baseline until final Overall Survival analysis data cut-off date of 30June2022', 'description': 'Overall survival is defined as the time from date of randomization to death due to any cause.'}, {'measure': 'Objective Response Rate', 'timeFrame': 'baseline until primary analysis data cut-off date of 31March2021', 'description': 'Objective Response Rate is defined as the proportion of patients with a centrally assessed best overall response of complete response or partial response according to RECIST v1.1.'}, {'measure': 'Investigator Assessed Progression Free Survival', 'timeFrame': 'baseline until primary analysis data cut-off date of 31March2021', 'description': 'Progression-free survival is defined as the time from the date of randomization to the date of first documented disease progression by investigator assessment according to RECIST v1.1 or death due to any cause, whichever occurred earlier.'}, {'measure': 'Patient Reported Outcomes for Health Related Quality of Life', 'timeFrame': 'baseline until primary analysis data cut-off date of 31March2021', 'description': 'Change in the global health status/Quality of Life (QoL) scale score of the European Organization for Research and Treatment for Cancer (EORTC) Quality of Life Questionnaire C30 from baseline (cycle 1). The raw score (1 to 7) has been transformed to a score ranging from 0 to 100. A higher score means a better outcome: hence a positive change from baseline means an improvement in global health status/Quality of Life and a negative change from baseline means a worsening of global health status/Quality of Life.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '39442070', 'type': 'DERIVED', 'citation': "Turner N, Saura C, Aftimos P, van den Tweel E, Oesterholt M, Koper N, Colleoni M, Kaczmarek E, Punie K, Song X, Armstrong A, Bianchi G, Stradella A, Ladoire S, Lim JSJ, Quenel-Tueux N, Tan TJ, Escriva-de-Romani S, O'Shaughnessy J; TULIP Trial Investigators. Trastuzumab Duocarmazine in Pretreated Human Epidermal Growth Factor Receptor 2-Positive Advanced or Metastatic Breast Cancer: An Open-Label, Randomized, Phase III Trial (TULIP). J Clin Oncol. 2025 Feb 10;43(5):513-523. doi: 10.1200/JCO.24.00529. Epub 2024 Oct 23."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to demonstrate that SYD985 \\[(vic-)trastuzumab duocarmazine\\] is superior to physician's choice in prolonging progression free survival.", 'detailedDescription': "This study is designed as a randomized, active-controlled, superiority study in patients with unresectable locally advanced or metastatic HER2-positive breast cancer. The patients should have had either progression during or after at least two HER2-targeting treatment regimens for locally advanced or metastatic disease or progression during or after (ado-)trastuzumab emtansine treatment.\n\nEligible patients will be randomly assigned (2:1) to receive SYD985 or physician's choice treatment until disease progression, unacceptable toxicity or study termination by the Sponsor. During treatment, patients will have to visit the clinical site to assess efficacy, quality of life (QoL), and safety using standardized criteria."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Female patients with histologically-confirmed, unresectable locally advanced or metastatic breast cancer;\n* Patients should have had either progression during or after at least two HER2-targeting treatment regimens for locally advanced or metastatic disease or progression during or after (ado-)trastuzumab emtansine treatment for locally advanced or metastatic disease;\n* HER2-positive tumor status;\n* Patients must have measurable or non-measurable disease that is evaluable per RECIST 1.1;\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;\n* Estimated life expectancy \\> 12 weeks at randomization;\n* Adequate organ function and blood cell counts.\n\nMain Exclusion Criteria:\n\n* Current or previous use of a prohibited medication as listed in the protocol;\n* History of infusion-related reactions and/or hypersensitivity to trastuzumab, (ado-)trastuzumab emtansine;\n* History of keratitis;\n* Severe, uncontrolled systemic disease at screening;\n* Left Ventricular Ejection Fraction (LVEF) \\< 50%, or a history of clinically significant decrease in LVEF during previous treatment with trastuzumab or (ado-)trastuzumab emtansine;\n* Cardiac troponin value above the Upper Limit of Normal (ULN);\n* History of clinically significant cardiovascular disease;\n* Untreated brain metastases, symptomatic brain metastases, brain metastases requiring steroids to manage symptoms, or treatment for brain metastases within 8 weeks prior to randomization;\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.'}, 'identificationModule': {'nctId': 'NCT03262935', 'acronym': 'TULIP', 'briefTitle': "SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer", 'organization': {'class': 'INDUSTRY', 'fullName': 'Byondis B.V.'}, 'officialTitle': "A Multi-centre, Open-label, Randomized Clinical Trial Comparing the Efficacy and Safety of the Antibody-drug Conjugate SYD985 to Physician's Choice in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer", 'orgStudyIdInfo': {'id': 'SYD985.002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '(vic-)trastuzumab duocarmazine', 'description': 'SYD985, every 3 weeks (Q3W)', 'interventionNames': ['Drug: (vic-)trastuzumab duocarmazine']}, {'type': 'ACTIVE_COMPARATOR', 'label': "Physician's choice", 'description': '1. Lap/Cap\n2. T/Cap\n3. T/Vino\n4. T/Eri', 'interventionNames': ["Drug: Physician's choice"]}], 'interventions': [{'name': '(vic-)trastuzumab duocarmazine', 'type': 'DRUG', 'otherNames': ['SYD985', 'Trastuzumab vc-seco-DUBA'], 'description': 'Intravenous SYD985, Q3W', 'armGroupLabels': ['(vic-)trastuzumab duocarmazine']}, {'name': "Physician's choice", 'type': 'DRUG', 'otherNames': ['Lapatinib (Lap)', 'Capecitabine (Cap)', 'Trastuzumab (T)', 'Vinorelbine (Vino)', 'Eribulin (Eri)'], 'description': 'See drug label', 'armGroupLabels': ["Physician's choice"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Southern Cancer Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85715', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Clinical Research Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92093', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Moores UCSD Cancer Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32503', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Woodlands Medical Specialists', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '21144', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Greenebaum Cancer Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21204', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Greater Baltimore Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Saint Luke's Hospital of Kansas City", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '28374', 'city': 'Pinehurst', 'state': 'North Carolina', 'country': 'United States', 'facility': 'FirstHealth Outpatient Cancer Center', 'geoPoint': {'lat': 35.19543, 'lon': -79.46948}}, {'zip': '43623', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Toledo Clinic Cancer Center', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Northwest Cancer Specialists', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Magee-Womens Hospital of UPMS', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology PA (Texas Oncology-Dallas Presbyterian Hospital)', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology- Baylor Charles A. 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