Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-06-07 @ 1:47 AM
Study NCT ID:
NCT03248492
Status:
TERMINATED
Last Update Posted:
2025-06-26
First Post:
2017-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000614160', 'term': 'trastuzumab deruxtecan'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CTRinfo_us@daiichisankyo.com', 'phone': '1-908-992-6400', 'title': 'Contact for Clinical Trial Information', 'organization': 'Daiichi Sankyo'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.', 'description': 'A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: DS-8201a Low Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 50, 'seriousNumAtRisk': 50, 'deathsNumAffected': 33, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Part 1: DS-8201a Medium Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 48, 'seriousNumAtRisk': 48, 'deathsNumAffected': 30, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Part 1: DS-8201a High Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 21, 'seriousNumAtRisk': 21, 'deathsNumAffected': 18, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'Part 2a: DS-8201a Low Dose', 'description': 'All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 2a in the continuation phase.', 'otherNumAtRisk': 130, 'deathsNumAtRisk': 130, 'otherNumAffected': 129, 'seriousNumAtRisk': 130, 'deathsNumAffected': 86, 'seriousNumAffected': 42}, {'id': 'EG004', 'title': 'Part 2b (Exploratory): DS-8201a Low Dose', 'description': 'All participants who were T-DM1 intolerant and treated at the recommend dose (5.4 mg/kg) in Part 2b in the continuation phase.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 3, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 37, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 102}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 61}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 50}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 41}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 28}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 70}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Odema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 and Part 2a: DS-8201a Low Dose', 'description': 'All T-DM1 resistant/refractory (R/R) participants who were treated in Part 1 or Part 2a at the recommended (5.4 mg/kg) dose.'}, {'id': 'OG001', 'title': 'Part 1 + Part 2a + Part 2b: DS-8201a Low Dose', 'description': 'All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.'}, {'id': 'OG002', 'title': 'Part 1: DS-8201a Medium Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.'}, {'id': 'OG003', 'title': 'Part 1: DS-8201a High Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.'}], 'classes': [{'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)', 'description': "The number of participants with objective response is assessed every six weeks from Cycle 1 Day 1 through discontinuation of treatment. Investigator-assessed objective response rate (ORR) was defined as the proportion of participants who achieved a best overall response of complete response or partial response based on local radiologists/investigators' tumor assessments.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Objective response rate (ORR) was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.'}, {'type': 'SECONDARY', 'title': 'Best Overall Tumor Response as Confirmed By the Investigator Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}, {'value': '184', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: DS-8201a Medium Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.'}, {'id': 'OG001', 'title': 'Part 1: DS-8201a High Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.'}, {'id': 'OG002', 'title': 'Part 1 + Part 2a: DS-8201a Low Dose', 'description': 'All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 1 or Part 2a.'}, {'id': 'OG003', 'title': 'Part 1 + Part 2a + Part 2b: DS-8201a Low Dose', 'description': 'All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.'}], 'classes': [{'title': 'Complete response', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Partial response', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}]}, {'title': 'Stable disease', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}]}, {'title': 'Progressive disease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Non-evaluable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)', 'description': 'Best overall tumor response was defined as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) by the investigator based on RECIST v1.1. Participants who were non-evaluable (NE) are also reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Best overall tumor response was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate and Clinical Benefit Rate as Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}, {'value': '184', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: DS-8201a Medium Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.'}, {'id': 'OG001', 'title': 'Part 1: DS-8201a High Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.'}, {'id': 'OG002', 'title': 'Part 1 + Part 2a: DS-8201a Low Dose', 'description': 'All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 1 or Part 2a.'}, {'id': 'OG003', 'title': 'Part 1 + Part 2a + Part 2b: DS-8201a Low Dose', 'description': 'All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.'}], 'classes': [{'title': 'Disease control rate', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '175', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}]}, {'title': 'Clinical benefit rate', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '130', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)', 'description': 'Number of participants with controlled disease and who received clinical benefit from treatment as assessed by independent central review. DCR was defined as the proportion of participants who achieved a best overall response of complete response, partial response, or stable disease. CBR was defined as the proportion of participants who achieved a best overall response of complete response or partial response or more than 6 months of stable disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Disease control rate (DCR) and clinical benefit rate (CBR) were assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (Complete Response or Partial Response) as Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: DS-8201a Medium Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.'}, {'id': 'OG001', 'title': 'Part 1: DS-8201a High Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.'}, {'id': 'OG002', 'title': 'Part 1 + Part 2a: DS-8201a Low Dose', 'description': 'All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 1 or Part 2a.'}, {'id': 'OG003', 'title': 'Part 1 + Part 2a + Part 2b: DS-8201a Low Dose', 'description': 'All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'There were not enough events to estimate a standard error for the median survival time.', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': 'NA'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '8.3'}, {'value': 'NA', 'comment': 'Lack of a median value is due to less than 50% of the participants experiencing the event.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Lack of a median value is due to less than 50% of the participants experiencing the event.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)', 'description': 'The estimated duration of confirmed response (complete response \\[CR\\] or partial response \\[PR\\]) was assessed by independent central review. Duration of response was defined as the time interval between the date of first documentation of objective response (CR or PR) and the date of the first objective documentation of disease progression or death due to any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with CR or PR were analyzed. Estimated duration of response was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival Estimate As Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}, {'value': '184', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: DS-8201a Medium Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.'}, {'id': 'OG001', 'title': 'Part 1: DS-8201a High Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.'}, {'id': 'OG002', 'title': 'Part 1 + Part 2a: DS-8201a Low Dose', 'description': 'All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 1 or Part 2a.'}, {'id': 'OG003', 'title': 'Part 1 + Part 2a + Part 2b: DS-8201a Low Dose', 'description': 'All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Lack of a median value is due to less than 50% of the participants experiencing the event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '13.2'}, {'value': 'NA', 'comment': 'There were not enough events to estimate a standard error for the median survival time.', 'groupId': 'OG002', 'lowerLimit': '10.6', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'There were not enough events to estimate a standard error for the median survival time.', 'groupId': 'OG003', 'lowerLimit': '10.6', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)', 'description': 'The point estimate of progression-free survival (PFS) is reported. PFS was defined as the time interval between the date of randomization/registration and the first documentation of disease progression or death due to any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Progression-free survival was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Sum of Diameters Over Time as Determined by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}, {'value': '184', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: DS-8201a Medium Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.'}, {'id': 'OG001', 'title': 'Part 1: DS-8201a High Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.'}, {'id': 'OG002', 'title': 'Part 1 + Part 2a: DS-8201a Low Dose', 'description': 'All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 1 or Part 2a.'}, {'id': 'OG003', 'title': 'Part 1 + Part 2a + Part 2b: DS-8201a Low Dose', 'description': 'All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.'}], 'classes': [{'title': 'Baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '167', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-26.2', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '-32.9', 'spread': '25.4', 'groupId': 'OG001'}, {'value': '-26.9', 'spread': '21.6', 'groupId': 'OG002'}, {'value': '-26.9', 'spread': '22.5', 'groupId': 'OG003'}]}]}, {'title': 'Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-39.6', 'spread': '22.7', 'groupId': 'OG000'}, {'value': '-43.6', 'spread': '28.1', 'groupId': 'OG001'}, {'value': '-39.9', 'spread': '24.5', 'groupId': 'OG002'}, {'value': '-40.1', 'spread': '24.9', 'groupId': 'OG003'}]}]}, {'title': 'Baseline to Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-50.1', 'spread': '22.1', 'groupId': 'OG000'}, {'value': '-58.5', 'spread': '29.4', 'groupId': 'OG001'}, {'value': '-44.4', 'spread': '27.8', 'groupId': 'OG002'}, {'value': '-44.9', 'spread': '28.0', 'groupId': 'OG003'}]}]}, {'title': 'Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-56.3', 'spread': '22.1', 'groupId': 'OG000'}, {'value': '-61.9', 'spread': '32.0', 'groupId': 'OG001'}, {'value': '-49.2', 'spread': '30.6', 'groupId': 'OG002'}, {'value': '-49.3', 'spread': '30.5', 'groupId': 'OG003'}]}]}, {'title': 'Baseline to Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-59.1', 'spread': '26.1', 'groupId': 'OG000'}, {'value': '-63.9', 'spread': '32.2', 'groupId': 'OG001'}, {'value': '-51.2', 'spread': '29.2', 'groupId': 'OG002'}, {'value': '-51.5', 'spread': '29.2', 'groupId': 'OG003'}]}]}, {'title': 'Baseline to Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-61.0', 'spread': '26.7', 'groupId': 'OG000'}, {'value': '-54.6', 'spread': '32.2', 'groupId': 'OG001'}, {'value': '-55.5', 'spread': '29.9', 'groupId': 'OG002'}, {'value': '-55.5', 'spread': '29.9', 'groupId': 'OG003'}]}]}, {'title': 'Best percent change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}, {'value': '169', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-59.5', 'spread': '28.2', 'groupId': 'OG000'}, {'value': '-65.3', 'spread': '27.7', 'groupId': 'OG001'}, {'value': '-50.5', 'spread': '28.3', 'groupId': 'OG002'}, {'value': '-50.6', 'spread': '28.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 6, 12, 18, 24, 30, 36 post dose', 'description': 'Best percent change in sum of diameters of measurable tumors was based on RECIST 1.1. The best percent change was defined as the percent change in the smallest sum of diameters from all post-baseline tumor assessments, taking as reference the baseline sum of diameters.', 'unitOfMeasure': 'Percent change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Best percent change from baseline in sum of diameters was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.'}, {'type': 'SECONDARY', 'title': 'Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Safety Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '130', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: DS-8201a Low Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.'}, {'id': 'OG001', 'title': 'Part 1: DS-8201a Medium Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.'}, {'id': 'OG002', 'title': 'Part 1: DS-8201a High Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.'}, {'id': 'OG003', 'title': 'Part 2a: DS-8201a Low Dose', 'description': 'All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in the continuation phase.'}, {'id': 'OG004', 'title': 'Part 2b (Exploratory): DS-8201a Low Dose', 'description': 'All participants who were T-DM1 intolerant and treated at the recommend dose (5.4 mg/kg) in the continuation phase.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Drug-related TEAEs', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Drug-related TEAEs of CTCAE ≥Grade 3', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Any serious TEAE', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Drug-related serious TEAEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'TEAEs associated with drug discontinuation', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Related TEAEs associated with drug discontinuation', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'TEAEs associated with dose reduction', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Drug-related TEAEs associated with dose reduction', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'TEAEs associated with dose interruption', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Related TEAEs associated with drug interruption', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'TEAEs associated with death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Drug-related TEAEs associated with death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 to Day 47 post last dose', 'description': 'TEAEs were assessed by severity and seriousness according to unique criteria. Severity described the intensity of an event and was graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL; Grade 4: Life-threatening consequences; urgent intervention indicated; and Grade 5: Death related to AE. Serious TEAEs were defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires inpatient hospitalization, or causes prolongation of existing hospitalization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Adverse event data were assessed in the Safety Analysis Set t data cut-off date of 21 March 2019.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: DS-8201a Low Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.'}, {'id': 'FG001', 'title': 'Part 1: DS-8201a Medium Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.'}, {'id': 'FG002', 'title': 'Part 1: DS-8201a High Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phase.'}, {'id': 'FG003', 'title': 'Part 2a: DS-8201a Low Dose', 'description': 'All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 2a in the continuation phase.'}, {'id': 'FG004', 'title': 'Part 2b (Exploratory): DS-8201a Low Dose', 'description': 'All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 2b in the continuation phase.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '130'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '130'}, {'groupId': 'FG004', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '66'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants who met all of the inclusion and none of the exclusion criteria were enrolled and randomized to treatment (Part 1) or received DS-8201a at the recommended dose (Part 2).', 'preAssignmentDetails': 'In Part 1, participants were randomized 1:1:1 to either 5.4 mg/kg, 6.4 mg/kg, or 7.4 mg/kg dose of DS-8201a. Two doses randomized 1:1 (5.4 or 6.4 mg/kg) were further evaluated. In Part 2, all T-DM1 resistant refractory participants (cohort 2a) or T-DM1 intolerant (cohort 2b) received DS-8201a at the recommended dose.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '130', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '253', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: DS-8201a Low Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.'}, {'id': 'BG001', 'title': 'Part 1: DS-8201a Medium Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.'}, {'id': 'BG002', 'title': 'Part 1: DS-8201a High Dose', 'description': 'T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.'}, {'id': 'BG003', 'title': 'Part 2a: DS-8201a Low Dose', 'description': 'All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 2a in the continuation phase.'}, {'id': 'BG004', 'title': 'Part 2b (Exploratory): DS-8201a Low Dose', 'description': 'All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 2b in the continuation phase.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '189', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '64', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.9', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '55.8', 'spread': '13.0', 'groupId': 'BG001'}, {'value': '54.4', 'spread': '10.5', 'groupId': 'BG002'}, {'value': '55.4', 'spread': '11.9', 'groupId': 'BG003'}, {'value': '49.8', 'spread': '9.2', 'groupId': 'BG004'}, {'value': '55.8', 'spread': '11.8', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '130', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '253', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '104', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '132', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Korea', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '40', 'groupId': 'BG005'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '77', 'groupId': 'BG005'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '56', 'groupId': 'BG005'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '29', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-26', 'size': 2555289, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-13T13:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'In Part 1, about 60 trastuzumab emtansine (T-DM1) resistant/refractory patients initially will be randomized into three treatment groups (low, medium and high doses) for Pharmacokinetics (PK), then about another 60 will be randomized into low and high doses to determine recommended dose (RD). After that, about 100 will receive the recommended dose in an open-label continuation stage (Part 2). About 10 TDM-1 intolerant patients will join the continuation stage as an exploratory only arm.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'HER2-positive patients will be classified into two groups: T-DM1 resistant/refractory (experimental) and T-DM1 intolerant (exploratory only).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 253}}, 'statusModule': {'whyStopped': 'The last participant was transitioned to alternative study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-09', 'studyFirstSubmitDate': '2017-08-10', 'resultsFirstSubmitDate': '2020-01-17', 'studyFirstSubmitQcDate': '2017-08-10', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-13', 'studyFirstPostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate as Confirmed by Independent Central Review Following Intravenous Administration of 5.4 mg/kg DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)', 'timeFrame': 'at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)', 'description': 'The number of participants with objective response was assessed every six weeks from Cycle 1 Day 1 through discontinuation of treatment, by independent central imaging facility review based on RECIST version 1.1.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate as Confirmed By the Investigator Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)', 'timeFrame': 'at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)', 'description': "The number of participants with objective response is assessed every six weeks from Cycle 1 Day 1 through discontinuation of treatment. Investigator-assessed objective response rate (ORR) was defined as the proportion of participants who achieved a best overall response of complete response or partial response based on local radiologists/investigators' tumor assessments."}, {'measure': 'Best Overall Tumor Response as Confirmed By the Investigator Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)', 'timeFrame': 'at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)', 'description': 'Best overall tumor response was defined as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) by the investigator based on RECIST v1.1. Participants who were non-evaluable (NE) are also reported.'}, {'measure': 'Disease Control Rate and Clinical Benefit Rate as Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)', 'timeFrame': 'at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)', 'description': 'Number of participants with controlled disease and who received clinical benefit from treatment as assessed by independent central review. DCR was defined as the proportion of participants who achieved a best overall response of complete response, partial response, or stable disease. CBR was defined as the proportion of participants who achieved a best overall response of complete response or partial response or more than 6 months of stable disease.'}, {'measure': 'Duration of Response (Complete Response or Partial Response) as Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)', 'timeFrame': 'at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)', 'description': 'The estimated duration of confirmed response (complete response \\[CR\\] or partial response \\[PR\\]) was assessed by independent central review. Duration of response was defined as the time interval between the date of first documentation of objective response (CR or PR) and the date of the first objective documentation of disease progression or death due to any cause.'}, {'measure': 'Progression-Free Survival Estimate As Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)', 'timeFrame': 'at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)', 'description': 'The point estimate of progression-free survival (PFS) is reported. PFS was defined as the time interval between the date of randomization/registration and the first documentation of disease progression or death due to any cause.'}, {'measure': 'Percent Change From Baseline in Sum of Diameters Over Time as Determined by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)', 'timeFrame': 'Baseline up to Week 6, 12, 18, 24, 30, 36 post dose', 'description': 'Best percent change in sum of diameters of measurable tumors was based on RECIST 1.1. The best percent change was defined as the percent change in the smallest sum of diameters from all post-baseline tumor assessments, taking as reference the baseline sum of diameters.'}, {'measure': 'Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Safety Analysis Set)', 'timeFrame': 'Day 0 to Day 47 post last dose', 'description': 'TEAEs were assessed by severity and seriousness according to unique criteria. Severity described the intensity of an event and was graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL; Grade 4: Life-threatening consequences; urgent intervention indicated; and Grade 5: Death related to AE. Serious TEAEs were defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires inpatient hospitalization, or causes prolongation of existing hospitalization.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HER-2 positive breast cancer', 'Metastatic or Unresectable', 'Resistant or refractory to T-DM1', 'DESTINY - Breast 01', 'Trastuzumab deruxtecan', 'T-DXd'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '36342619', 'type': 'DERIVED', 'citation': 'Dunton K, Vondeling G, Hancock E, Petrou M, Burn O, Paine A. Methods for Estimating Long-Term Outcomes for Trastuzumab Deruxtecan in HER2-Positive Unresectable or Metastatic Breast Cancer After Two or More Anti-HER2 Therapies. Target Oncol. 2022 Nov;17(6):655-663. doi: 10.1007/s11523-022-00923-9. Epub 2022 Nov 7.'}, {'pmid': '35964548', 'type': 'DERIVED', 'citation': 'Rugo HS, Bianchini G, Cortes J, Henning JW, Untch M. Optimizing treatment management of trastuzumab deruxtecan in clinical practice of breast cancer. ESMO Open. 2022 Aug;7(4):100553. doi: 10.1016/j.esmoop.2022.100553. Epub 2022 Aug 11.'}, {'pmid': '35642907', 'type': 'DERIVED', 'citation': 'Bardia A, Harnden K, Mauro L, Pennisi A, Armitage M, Soliman H. Clinical Practices and Institutional Protocols on Prophylaxis, Monitoring, and Management of Selected Adverse Events Associated with Trastuzumab Deruxtecan. Oncologist. 2022 Aug 5;27(8):637-645. doi: 10.1093/oncolo/oyac107.'}, {'pmid': '34263665', 'type': 'DERIVED', 'citation': 'Modi S. Trastuzumab deruxtecan in previously treated HER2-positive metastatic breast cancer: Plain language summary of the DESTINY-Breast01 study. Future Oncol. 2021 Sep 1;17(26):3415-3423. doi: 10.2217/fon-2021-0427. Epub 2021 Jul 15.'}, {'pmid': '33999422', 'type': 'DERIVED', 'citation': 'Yin O, Iwata H, Lin CC, Tamura K, Watanabe J, Wada R, Kastrissios H, AbuTarif M, Garimella T, Lee C, Zhang L, Shahidi J, LaCreta F. Exposure-Response Relationships in Patients With HER2-Positive Metastatic Breast Cancer and Other Solid Tumors Treated With Trastuzumab Deruxtecan. Clin Pharmacol Ther. 2021 Oct;110(4):986-996. doi: 10.1002/cpt.2291. Epub 2021 Jun 10.'}, {'pmid': '31825192', 'type': 'DERIVED', 'citation': 'Modi S, Saura C, Yamashita T, Park YH, Kim SB, Tamura K, Andre F, Iwata H, Ito Y, Tsurutani J, Sohn J, Denduluri N, Perrin C, Aogi K, Tokunaga E, Im SA, Lee KS, Hurvitz SA, Cortes J, Lee C, Chen S, Zhang L, Shahidi J, Yver A, Krop I; DESTINY-Breast01 Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer. N Engl J Med. 2020 Feb 13;382(7):610-621. doi: 10.1056/NEJMoa1914510. Epub 2019 Dec 11.'}]}, 'descriptionModule': {'briefSummary': 'Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug. It has not yet been approved for use. DS-8201a may slow down tumor growth. This might improve outcomes for these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women the age of majority in their country\n* Has pathologically documented breast cancer that:\n\n 1. is unresectable or metastatic\n 2. has HER2 positive expression confirmed per protocol\n* Has an adequate tumor sample\n* Has at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1\n* Has protocol-defined adequate cardiac, renal and hepatic function\n* Agrees to follow protocol-defined method(s) of contraception\n\nExclusion Criteria:\n\n* Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia\n* Has a corrected QT interval (QTc) prolongation to \\> 450 millisecond (ms) in males and \\> 470 ms in females\n* Has a medical history of clinically significant lung disease\n* Is suspected to have certain other protocol-defined diseases based on imaging at screening period\n* Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:\n\n 1. safety or well-being of the participant or offspring\n 2. safety of study staff\n 3. analysis of results'}, 'identificationModule': {'nctId': 'NCT03248492', 'briefTitle': 'A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Phase 2, Multicenter, Open-Label Study of DS-8201a, an Anti-HER2-Antibody Drug Conjugate (ADC) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1 (DESTINY-Breast01)', 'orgStudyIdInfo': {'id': 'DS8201-A-U201'}, 'secondaryIdInfos': [{'id': '2016-004986-18', 'type': 'EUDRACT_NUMBER'}, {'id': 'JapicCTI-173693(en)', 'type': 'REGISTRY', 'domain': 'JapicCTI'}, {'id': 'DESTINY-Breast01', 'type': 'OTHER', 'domain': 'Daiichi Sankyo and AstraZeneca'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DS-8201a Low Dose', 'description': 'T-DM1 resistant/refractory (R/R) patients in the low dose treatment group', 'interventionNames': ['Drug: DS-8201a']}, {'type': 'EXPERIMENTAL', 'label': 'DS-8201a Medium Dose', 'description': 'T-DM1 resistant/refractory (R/R) patients in the medium dose treatment group', 'interventionNames': ['Drug: DS-8201a']}, {'type': 'EXPERIMENTAL', 'label': 'DS-8201a High Dose', 'description': 'T-DM1 resistant/refractory (R/R) patients in the high dose treatment group', 'interventionNames': ['Drug: DS-8201a']}, {'type': 'OTHER', 'label': 'Exploratory Arm', 'description': 'In Part 2b- Continuation Stage, about 10 T-DM1 Intolerant patients will receive the DS-8201a recommended dose (RD) as an exploratory arm', 'interventionNames': ['Drug: DS-8201a']}], 'interventions': [{'name': 'DS-8201a', 'type': 'DRUG', 'otherNames': ['Experimental product'], 'description': 'DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as low, medium and high intravenous (IV) doses for Part 1 of the trial. 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'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/daiichi-sankyo/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/', 'accessCriteria': "Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. 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